Trial Outcomes & Findings for Avelumab for People With Recurrent Respiratory Papillomatosis (NCT NCT02859454)
NCT ID: NCT02859454
Last Updated: 2021-11-02
Results Overview
The Derkay is an objective score based on the number of sites and bulkiness of papillomas within the pharynx, larynx and trachea and a subjective score determined by voice and treating symptoms. Complete response is assessed by The Derkay Staging System which is defined as a physical exam and/or clinic-based flexible nasopharyngolaryngoscopy and/or tracheoscopy, exam under anesthesia with endoscopy and biopsies; no evidence of papillomas on physical exam and/or clinic based flexible nasopharyngolaryngoscopy and/or tracheoscopy; and no evidence of papillomas by exam under anesthesia (sedation or general anesthesia) with endoscopy and biopsies.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Disease response was performed at 6 and 12 weeks after the first dose of Avelumab. Patients who experience a complete response will be evaluated every 6 weeks x 3, then every 12 weeks x 3, then every 26 weeks x 2 or until disease progression,up to 3 years
Results posted on
2021-11-02
Participant Flow
Participant milestones
| Measure |
Avelumab
Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Avelumab
Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
|
|---|---|
|
Overall Study
PI discretion/off study prior to trtmt
|
1
|
Baseline Characteristics
Avelumab for People With Recurrent Respiratory Papillomatosis
Baseline characteristics by cohort
| Measure |
Avelumab
n=13 Participants
Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
46.95 years
STANDARD_DEVIATION 15.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 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
|
2 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
|
Patients Who Had Repeated Endoscopic Debulking to Remove Paillomatosis Lesions Prior to Treatment
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Disease response was performed at 6 and 12 weeks after the first dose of Avelumab. Patients who experience a complete response will be evaluated every 6 weeks x 3, then every 12 weeks x 3, then every 26 weeks x 2 or until disease progression,up to 3 yearsPopulation: Nine of twelve patients had evaluable laryngotracheal disease as assessed by clinical endoscopy.
The Derkay is an objective score based on the number of sites and bulkiness of papillomas within the pharynx, larynx and trachea and a subjective score determined by voice and treating symptoms. Complete response is assessed by The Derkay Staging System which is defined as a physical exam and/or clinic-based flexible nasopharyngolaryngoscopy and/or tracheoscopy, exam under anesthesia with endoscopy and biopsies; no evidence of papillomas on physical exam and/or clinic based flexible nasopharyngolaryngoscopy and/or tracheoscopy; and no evidence of papillomas by exam under anesthesia (sedation or general anesthesia) with endoscopy and biopsies.
Outcome measures
| Measure |
Avelumab
n=9 Participants
Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
|
All Participants at 6 Weeks
All participants Voice Handicap Index-10 Score at 6 Weeks.
Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
|
All Participants at 12 Weeks
All participants Voice Handicap Index-10 Score at 12 Weeks.
Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
|
|---|---|---|---|
|
Number of Patients With Laryngotracheal Recurrent Respiratory Papillomatosis (RPP) Who Achieve a Complete Response With Avelumab as Measured by Derkay Score Calculated From Clinical Endoscopy
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Disease response was performed at 6 and 12 weeks after the first dose of Avelumab. Patients who experience a complete response will be evaluated every 6 weeks x 3, then every 12 weeks x 3, then every 26 weeks x 2 or until disease progression,up to 3 yearsPopulation: Four of twelve patients had evaluable pulmonary disease as assessed by CT scan.
Complete response is measured by The Response Criteria in Solid Tumors (RECIST) v1.1 calculated from chest CT scans. Complete response is absence of disease (e.g., lesions) by imaging.
Outcome measures
| Measure |
Avelumab
n=4 Participants
Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
|
All Participants at 6 Weeks
All participants Voice Handicap Index-10 Score at 6 Weeks.
Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
|
All Participants at 12 Weeks
All participants Voice Handicap Index-10 Score at 12 Weeks.
Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
|
|---|---|---|---|
|
Number of Patients With Pulmonary Recurrent Respiratory Papillomatosis (RPP) Who Achieve a Complete Response With Avelumab as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Calculated From Chest Computed Tomography (CT) Scans
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, and 12 weeks after the first dose of Avelumab.Population: Only one participant in each row contributed data in each row.
The Voice Handicap Index-10 questionnaire (as measured by derkay score) consists of 10 questions and determines whether a participant has a voice handicap. The scoring options for each question range from 0 (for never) to 4 (for always). The total scores (combined value from all 10 questions) range from 0 - 40. Higher scores represent a worse voice handicap. Lower scores represent a less voice handicap.
Outcome measures
| Measure |
Avelumab
n=12 Participants
Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
|
All Participants at 6 Weeks
n=12 Participants
All participants Voice Handicap Index-10 Score at 6 Weeks.
Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
|
All Participants at 12 Weeks
n=12 Participants
All participants Voice Handicap Index-10 Score at 12 Weeks.
Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
|
|---|---|---|---|
|
Effect of Treatment With Avelumab on Voice Handicap Index-10 Score
Patient 1
|
26 scores on a scale
|
22 scores on a scale
|
23 scores on a scale
|
|
Effect of Treatment With Avelumab on Voice Handicap Index-10 Score
Patient 2
|
9 scores on a scale
|
12 scores on a scale
|
3 scores on a scale
|
|
Effect of Treatment With Avelumab on Voice Handicap Index-10 Score
Patient 6
|
19 scores on a scale
|
0 scores on a scale
|
0 scores on a scale
|
|
Effect of Treatment With Avelumab on Voice Handicap Index-10 Score
Patient 7
|
40 scores on a scale
|
21 scores on a scale
|
18 scores on a scale
|
|
Effect of Treatment With Avelumab on Voice Handicap Index-10 Score
Patient 3
|
40 scores on a scale
|
37 scores on a scale
|
38 scores on a scale
|
|
Effect of Treatment With Avelumab on Voice Handicap Index-10 Score
Patient 4
|
17 scores on a scale
|
16 scores on a scale
|
16 scores on a scale
|
|
Effect of Treatment With Avelumab on Voice Handicap Index-10 Score
Patient 5
|
12 scores on a scale
|
2 scores on a scale
|
1 scores on a scale
|
|
Effect of Treatment With Avelumab on Voice Handicap Index-10 Score
Patient 8
|
30 scores on a scale
|
35 scores on a scale
|
29 scores on a scale
|
|
Effect of Treatment With Avelumab on Voice Handicap Index-10 Score
Patient 9
|
37 scores on a scale
|
40 scores on a scale
|
40 scores on a scale
|
|
Effect of Treatment With Avelumab on Voice Handicap Index-10 Score
Patient 10
|
18 scores on a scale
|
11 scores on a scale
|
12 scores on a scale
|
|
Effect of Treatment With Avelumab on Voice Handicap Index-10 Score
Patient 11
|
18 scores on a scale
|
9 scores on a scale
|
0 scores on a scale
|
|
Effect of Treatment With Avelumab on Voice Handicap Index-10 Score
Patient 13
|
18 scores on a scale
|
19 scores on a scale
|
15 scores on a scale
|
SECONDARY outcome
Timeframe: Disease response was performed at 6 and 12 weeks after the first dose of Avelumab. Patients who experience a complete response will be evaluated every 6 weeks x 3, then every 12 weeks x 3, then every 26 weeks x 2 or until disease progression,up to 3 yearsPopulation: Nine of twelve patients had evaluable laryngotracheal disease as assessed by clinical endoscopy.
Partial response is assessed by flexible nasopharyngolaryngoscopy and/or tracheoscopy using the Derkay staging system if the patient does not have pulmonary disease. The Derkay is an objective score based on the number of sites and bulkiness of papillomas within the pharynx, larynx and trachea and a subjective score determined by voice and treating symptoms. Partial response is a decrease in Derkay anatomic score of 30% or greater.
Outcome measures
| Measure |
Avelumab
n=9 Participants
Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
|
All Participants at 6 Weeks
All participants Voice Handicap Index-10 Score at 6 Weeks.
Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
|
All Participants at 12 Weeks
All participants Voice Handicap Index-10 Score at 12 Weeks.
Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
|
|---|---|---|---|
|
Number of Patients With Laryngotracheal Recurrent Respiratory Papillomatosis (RPP) Who Achieve a Partial Response With Avelumab as Measured by Derkay Score Calculated From Clinical Endoscopy
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Disease response was performed at 6 and 12 weeks after the first dose of Avelumab. Patients who experience a complete response will be evaluated every 6 weeks x 3, then every 12 weeks x 3, then every 26 weeks x 2 or until disease progression, up to 3 yearPopulation: Four of twelve patients had evaluable pulmonary disease as assessed by CT scan.
Partial response assessed by imaging using RECIST v1.1. is defined as a ≥ 30% decrease in the sum of the longest diameters of target lesions compared with baseline.
Outcome measures
| Measure |
Avelumab
n=4 Participants
Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
|
All Participants at 6 Weeks
All participants Voice Handicap Index-10 Score at 6 Weeks.
Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
|
All Participants at 12 Weeks
All participants Voice Handicap Index-10 Score at 12 Weeks.
Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
|
|---|---|---|---|
|
Number of Patients With Pulmonary Recurrent Respiratory Papillomatosis (RPP) Who Achieve a Partial Response With Avelumab as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Calculated From Chest Computed Tomography (CT) Scans
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Disease response was performed at 6 and 12 weeks after the first dose of Avelumab. Patients who experience a complete response will be evaluated every 6 weeks x 3, then every 12 weeks x 3, then every 26 weeks x 2 or until disease progression,up to 4.5 yrsPopulation: 5/12 participants were evaluable for this outcome measure.
The duration of clinical responses to Avelumab is calculated from the protocol end of treatment endoscopic debulking to the next clinically indicated endoscopic debulking procedure.
Outcome measures
| Measure |
Avelumab
n=5 Participants
Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
|
All Participants at 6 Weeks
All participants Voice Handicap Index-10 Score at 6 Weeks.
Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
|
All Participants at 12 Weeks
All participants Voice Handicap Index-10 Score at 12 Weeks.
Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
|
|---|---|---|---|
|
Duration of Clinical Responses to Avelumab
|
14.7 Months
Interval 4.5 to 51.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 28 months and 20 days.Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Avelumab
n=13 Participants
Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
|
All Participants at 6 Weeks
All participants Voice Handicap Index-10 Score at 6 Weeks.
Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
|
All Participants at 12 Weeks
All participants Voice Handicap Index-10 Score at 12 Weeks.
Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
|
|---|---|---|---|
|
Number of Participants With Serious and Non-serious Adverse Events
|
13 Participants
|
—
|
—
|
Adverse Events
Avelumab
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Avelumab
n=13 participants at risk
Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
|
|---|---|
|
Cardiac disorders
Cardiac disorders - Other, Stress cardiomyopathy
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Gastrointestinal disorders
Diarrhea
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Vascular disorders
Hypotension
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Gastrointestinal disorders
Ileus
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
Other adverse events
| Measure |
Avelumab
n=13 participants at risk
Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
Avelumab: Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • Number of events 2 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Blood and lymphatic system disorders
Anemia
|
15.4%
2/13 • Number of events 3 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Cardiac disorders
Cardiac disorders - Other, Stress cardiomyopathy
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Cardiac disorders
Cardiac troponin I increased
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
General disorders
Chills
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Gastrointestinal disorders
Constipation
|
15.4%
2/13 • Number of events 2 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Gastrointestinal disorders
Dry mouth
|
38.5%
5/13 • Number of events 9 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.7%
1/13 • Number of events 2 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Nervous system disorders
Dysgeusia
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
General disorders
Edema limbs
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Cardiac disorders
Ejection fraction decreased
|
7.7%
1/13 • Number of events 2 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
General disorders
Fatigue
|
53.8%
7/13 • Number of events 11 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
General disorders
Fever
|
23.1%
3/13 • Number of events 4 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Nervous system disorders
Headache
|
30.8%
4/13 • Number of events 7 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Vascular disorders
Hypertension
|
61.5%
8/13 • Number of events 41 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Endocrine disorders
Hyperthyroidism
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
15.4%
2/13 • Number of events 3 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Vascular disorders
Hypotension
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Infections and infestations
Infections and infestations - Other, yeast infection
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
General disorders
Infusion related reaction
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Psychiatric disorders
Insomnia
|
15.4%
2/13 • Number of events 2 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
General disorders
Malaise
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Infections and infestations
Mucosal infection
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Gastrointestinal disorders
Nausea
|
30.8%
4/13 • Number of events 8 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Investigations
Neutrophil count decreased
|
7.7%
1/13 • Number of events 2 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
General disorders
Pain
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.4%
2/13 • Number of events 3 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Cardiac disorders
Sinus bradycardia
|
38.5%
5/13 • Number of events 10 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Cardiac disorders
Sinus tachycardia
|
23.1%
3/13 • Number of events 8 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
15.4%
2/13 • Number of events 2 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
2/13 • Number of events 3 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
|
Investigations
White blood cell decreased
|
15.4%
2/13 • Number of events 3 • Date treatment consent signed to date off study, approximately 28 months and 20 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place