Trial Outcomes & Findings for Reduced-intensity Therapy for Oropharyngeal Cancer in Non-smoking HPV-16 Positive Patients (NCT NCT01663259)
NCT ID: NCT01663259
Last Updated: 2021-01-19
Results Overview
Number of patients whose tumors recur (includes local, regional, and distant recurrence; and second primaries). Note: Research indicates that freedom from local and regional progression (FFLRP) is a more meaningful measure. Therefore, the percentage of patients with FFLRP is included below as a Post-Hoc measure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
43 participants
Primary outcome timeframe
2 years
Results posted on
2021-01-19
Participant Flow
43 patients consented, but one never began treatment.
Participant milestones
| Measure |
Cetuximab + Radiotherapy
Patients received a single loading dose public) of cetuximab 400 mg/m (Day 0), then weekly cetuximab 250 mg/m concurrent with radiation. Within approximately 4 days after first (loading) dose of cetuximab, patients received radiation administered as 70 Gy in 35 fractions to the gross tumor, 50-60 Gy to subclinical target volumes.
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reduced-intensity Therapy for Oropharyngeal Cancer in Non-smoking HPV-16 Positive Patients
Baseline characteristics by cohort
| Measure |
Cetuximab + Radiotherapy
n=42 Participants
Patients received a single loading dose public) of cetuximab 400 mg/m (Day 0), then weekly cetuximab 250 mg/m concurrent with radiation. Within approximately 4 days after first (loading) dose of cetuximab, patients received radiation administered as 70 Gy in 35 fractions to the gross tumor, 50-60 Gy to subclinical target volumes.
|
|---|---|
|
Age, Continuous
|
58 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
42 Participants
n=99 Participants
|
|
Smoking
Yes, current
|
1 Participants
n=99 Participants
|
|
Smoking
Yes, past
|
5 Participants
n=99 Participants
|
|
Smoking
No
|
36 Participants
n=99 Participants
|
|
Cancer Location
Oropharynx
|
42 Participants
n=99 Participants
|
|
Cancer Location
Oral Cavity
|
0 Participants
n=99 Participants
|
|
Cancer Location
Auditory Canal
|
0 Participants
n=99 Participants
|
|
Cancer Location
Hypopharynx
|
0 Participants
n=99 Participants
|
|
Cancer Location
Unknown Primary
|
0 Participants
n=99 Participants
|
|
HPV Status
Positive
|
42 Participants
n=99 Participants
|
|
HPV Status
Negative
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 yearsNumber of patients whose tumors recur (includes local, regional, and distant recurrence; and second primaries). Note: Research indicates that freedom from local and regional progression (FFLRP) is a more meaningful measure. Therefore, the percentage of patients with FFLRP is included below as a Post-Hoc measure.
Outcome measures
| Measure |
Cetuximab + Radiotherapy
n=42 Participants
Patients received a single loading dose of cetuximab and a Cetuximab infusion delivered once a week during radiotherapy.
|
|---|---|
|
Rate of Recurrence
|
8 Participants
|
SECONDARY outcome
Timeframe: 3 yearsIn order to evaluate the toxicity in patients receiving cetuximab-RT, adverse events were clustered into three categories: None, Mild-Moderate (grade 1 or 2), and Severe (grade 3 or 4). Graded according to the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4).
Outcome measures
| Measure |
Cetuximab + Radiotherapy
n=42 Participants
Patients received a single loading dose of cetuximab and a Cetuximab infusion delivered once a week during radiotherapy.
|
|---|---|
|
Number of Participants With Adverse Events
None
|
0 Participants
|
|
Number of Participants With Adverse Events
Mild-Moderate
|
14 Participants
|
|
Number of Participants With Adverse Events
Severe
|
28 Participants
|
SECONDARY outcome
Timeframe: 3 yearsToxicities are measured by number of participants who experience one or more types or indicator of toxicity, shown as all grades and grades 3-4. As each participant could have multiple toxicities, the number of incidents outnumbers the number of participants. Toxicities graded according to the CTCAE v4.
Outcome measures
| Measure |
Cetuximab + Radiotherapy
n=42 Participants
Patients received a single loading dose of cetuximab and a Cetuximab infusion delivered once a week during radiotherapy.
|
|---|---|
|
Treatment Related Toxicities
All Grades : Cutaneous Toxicity
|
38 participants
|
|
Treatment Related Toxicities
All Grades : Mucositis
|
42 participants
|
|
Treatment Related Toxicities
All Grades : Dysphagia
|
37 participants
|
|
Treatment Related Toxicities
All Grades : Hematologic Toxicity
|
13 participants
|
|
Treatment Related Toxicities
Grades 3-4 : Cutaneous Toxicity
|
3 participants
|
|
Treatment Related Toxicities
Grades 3-4 : Mucositis
|
19 participants
|
|
Treatment Related Toxicities
Grades 3-4 : Dysphagia
|
7 participants
|
|
Treatment Related Toxicities
Grades 3-4 : Hematologic Toxicity
|
6 participants
|
SECONDARY outcome
Timeframe: Day 7Population: 8 participants had a sample size sufficient for EGFR analysis.
The ratio (fold change) of tumor EGFR post/pre loading dose of cetuximab. Reported as the mean of fold changes across all participants who had an evaluable tumor sample.
Outcome measures
| Measure |
Cetuximab + Radiotherapy
n=8 Participants
Patients received a single loading dose of cetuximab and a Cetuximab infusion delivered once a week during radiotherapy.
|
|---|---|
|
Mean Change in Tumor Epidermal Growth Factor Receptor (EGFR)
|
1.2 fold change
Interval 0.1 to 2.5
|
SECONDARY outcome
Timeframe: Day 7Population: 2 participants had a sample size sufficient for pEGFR analysis.
The ratio (fold change) of tumor pEGFR post/pre loading dose of cetuximab. Reported as the mean of fold changes across all participants who had an evaluable tumor sample.
Outcome measures
| Measure |
Cetuximab + Radiotherapy
n=2 Participants
Patients received a single loading dose of cetuximab and a Cetuximab infusion delivered once a week during radiotherapy.
|
|---|---|
|
Mean Change in Tumor Phosphorylated EGFR (pEGFR)
|
0.55 fold change
Interval 0.5 to 0.6
|
SECONDARY outcome
Timeframe: Day 7Population: 7 participants had a sample size sufficient for EGFR analysis.
Normal mucosa EGFR was assessed for comparison with EGFR in tumor sample. The fold change in tumor EGFR level post/pre loading dose of cetuximab, relative to fold change in normal mucosa EGFR level post/pre loading dose of cetuximab was summarized across all participants who had an evaluable tumor sample and normal mucosa sample. The value reported is the ratio of fold change in tumor/fold change in buccal EGFR.
Outcome measures
| Measure |
Cetuximab + Radiotherapy
n=7 Participants
Patients received a single loading dose of cetuximab and a Cetuximab infusion delivered once a week during radiotherapy.
|
|---|---|
|
Change in Tumor EGFR Level Relative to EGFR in Normal Mucosa
|
1.31 ratio
Interval 0.1 to 2.5
|
POST_HOC outcome
Timeframe: 2 yearsPercentage of participants who survived without recurrent disease, from the time of enrollment to 1 and 2 years.
Outcome measures
| Measure |
Cetuximab + Radiotherapy
n=42 Participants
Patients received a single loading dose of cetuximab and a Cetuximab infusion delivered once a week during radiotherapy.
|
|---|---|
|
Disease Free Survival Rate
1 year
|
85.7 Percentage of participants
Interval 75.8 to 97.0
|
|
Disease Free Survival Rate
2 year
|
81 Percentage of participants
Interval 69.9 to 93.7
|
POST_HOC outcome
Timeframe: 2 yearsPercentage of participants alive at 1 and 2 years after enrollment.
Outcome measures
| Measure |
Cetuximab + Radiotherapy
n=42 Participants
Patients received a single loading dose of cetuximab and a Cetuximab infusion delivered once a week during radiotherapy.
|
|---|---|
|
Overall Survival Rate
1 year
|
97.6 Percentage of participants
Interval 93.1 to 100.0
|
|
Overall Survival Rate
2 year
|
95.2 Percentage of participants
Interval 89.0 to 100.0
|
POST_HOC outcome
Timeframe: 2 yearsPercentage of participants without first local or regional recurrence at one and at two years from the time of enrollment. Local recurrence refers to mouth or throat; regional recurrence refers to nearby lymph nodes.
Outcome measures
| Measure |
Cetuximab + Radiotherapy
n=42 Participants
Patients received a single loading dose of cetuximab and a Cetuximab infusion delivered once a week during radiotherapy.
|
|---|---|
|
Freedom From Local Regional Progression (FFLRP)
1 year
|
87.9 percentage of participants
Interval 75.8 to 97.0
|
|
Freedom From Local Regional Progression (FFLRP)
2 years
|
87.9 percentage of participants
Interval 69.9 to 93.7
|
Adverse Events
Cetuximab
Serious events: 9 serious events
Other events: 42 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cetuximab
n=42 participants at risk
Patients received a single loading dose of cetuximab and a Cetuximab infusion delivered once a week during radiotherapy.
|
|---|---|
|
Gastrointestinal disorders
Colitis
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - other
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
9.5%
4/42 • Number of events 4 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Oral pain
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Infections and infestations
Lung infection
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Investigations
Alanine aminotransferase increased
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Investigations
Lymphocyte count decreased
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Nervous system disorders
Cognitive disturbance
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Confusion
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.4%
1/42 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Cetuximab
n=42 participants at risk
Patients received a single loading dose of cetuximab and a Cetuximab infusion delivered once a week during radiotherapy.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
11.9%
5/42 • Number of events 5 • 3 years
|
|
Blood and lymphatic system disorders
Lymph node pain
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Cardiac disorders
Sinus tachycardia
|
7.1%
3/42 • Number of events 5 • 3 years
|
|
Ear and labyrinth disorders
External ear inflammation
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
21.4%
9/42 • Number of events 9 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
9.5%
4/42 • Number of events 6 • 3 years
|
|
Gastrointestinal disorders
Dry mouth
|
95.2%
40/42 • Number of events 92 • 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
95.2%
40/42 • Number of events 96 • 3 years
|
|
Gastrointestinal disorders
Esophagitis
|
97.6%
41/42 • Number of events 84 • 3 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.8%
2/42 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
50.0%
21/42 • Number of events 51 • 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
100.0%
42/42 • Number of events 115 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
57.1%
24/42 • Number of events 46 • 3 years
|
|
Gastrointestinal disorders
Oral pain
|
14.3%
6/42 • Number of events 15 • 3 years
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
28.6%
12/42 • Number of events 18 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
21.4%
9/42 • Number of events 16 • 3 years
|
|
General disorders
Chills
|
14.3%
6/42 • Number of events 7 • 3 years
|
|
General disorders
Facial pain
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
General disorders
Fatigue
|
61.9%
26/42 • Number of events 45 • 3 years
|
|
General disorders
Fever
|
9.5%
4/42 • Number of events 5 • 3 years
|
|
General disorders
Flu like symptoms
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
General disorders
Infusion related reaction
|
7.1%
3/42 • Number of events 3 • 3 years
|
|
General disorders
Pain
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Immune system disorders
Allergic reaction
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Infections and infestations
Lung infection
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Infections and infestations
Papulopustular rash
|
4.8%
2/42 • Number of events 4 • 3 years
|
|
Infections and infestations
Paronychia
|
7.1%
3/42 • Number of events 3 • 3 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
90.5%
38/42 • Number of events 64 • 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Investigations
Alanine aminotransferase increased
|
21.4%
9/42 • Number of events 13 • 3 years
|
|
Investigations
Alkaline phosphatase increased
|
4.8%
2/42 • Number of events 2 • 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
7/42 • Number of events 9 • 3 years
|
|
Investigations
Blood bilirubin increased
|
7.1%
3/42 • Number of events 3 • 3 years
|
|
Investigations
Creatinine increased
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Investigations
Lymphocyte count decreased
|
33.3%
14/42 • Number of events 43 • 3 years
|
|
Investigations
Platelet count decreased
|
9.5%
4/42 • Number of events 4 • 3 years
|
|
Investigations
Urine output decreased
|
4.8%
2/42 • Number of events 2 • 3 years
|
|
Investigations
Weight loss
|
26.2%
11/42 • Number of events 14 • 3 years
|
|
Investigations
White blood cell decreased
|
9.5%
4/42 • Number of events 8 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
19.0%
8/42 • Number of events 10 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
42.9%
18/42 • Number of events 31 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
7/42 • Number of events 11 • 3 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.8%
2/42 • Number of events 3 • 3 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.8%
2/42 • Number of events 2 • 3 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.8%
2/42 • Number of events 3 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.4%
1/42 • Number of events 5 • 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
11.9%
5/42 • Number of events 6 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
7.1%
3/42 • Number of events 3 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.8%
2/42 • Number of events 2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.8%
2/42 • Number of events 2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
7.1%
3/42 • Number of events 4 • 3 years
|
|
Nervous system disorders
Akathisia
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Nervous system disorders
Dizziness
|
7.1%
3/42 • Number of events 3 • 3 years
|
|
Nervous system disorders
Dysgeusia
|
100.0%
42/42 • Number of events 91 • 3 years
|
|
Nervous system disorders
Dysphasia
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Nervous system disorders
Headache
|
21.4%
9/42 • Number of events 11 • 3 years
|
|
Nervous system disorders
Myelitis
|
4.8%
2/42 • Number of events 2 • 3 years
|
|
Nervous system disorders
Paresthesia
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Nervous system disorders
Tremor
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Anxiety
|
4.8%
2/42 • Number of events 2 • 3 years
|
|
Psychiatric disorders
Confusion
|
2.4%
1/42 • Number of events 2 • 3 years
|
|
Psychiatric disorders
Depression
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Hematuria
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Urinary frequency
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Urine discoloration
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.8%
2/42 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.8%
2/42 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
7.1%
3/42 • Number of events 3 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
3/42 • Number of events 3 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.4%
1/42 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
11.9%
5/42 • Number of events 7 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
19.0%
8/42 • Number of events 8 • 3 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Fat atrophy
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
4.8%
2/42 • Number of events 2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
7.1%
3/42 • Number of events 3 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.9%
5/42 • Number of events 5 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
83.3%
35/42 • Number of events 59 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
4.8%
2/42 • Number of events 3 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Vascular disorders
Hypotension
|
2.4%
1/42 • Number of events 2 • 3 years
|
|
Vascular disorders
Superficial thrombophlebitis
|
2.4%
1/42 • Number of events 1 • 3 years
|
Additional Information
Michelle Mierzwa
University of Michigan Rogel Cancer Center
Phone: 734-936-7810
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place