Trial Outcomes & Findings for Topical Imiquimod and Abraxane in Treating Patients With Advanced Breast Cancer (NCT NCT00821964)
NCT ID: NCT00821964
Last Updated: 2018-01-02
Results Overview
Tumor responses will be determined using the sum of the products of the largest perpendicular dimensions. Target lesions will be evaluated by the following response criteria: complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). Evaluation of target lesions per modified WHO response criteria: * Complete response (CR): complete clearance (100%) of target lesion(s) * Partial response (PR): ≥ 50% decrease in target lesion size * Stable disease (SD): \< 50% decrease in target lesion size * Progressive (PD): ≥ 25% increase in target lesion size Overall Response Rate (ORR) determined at end of study treatment which was 1 week after cycle #3, unless patient was withdrawn from study. If patient was withdrawn from study, then ORR was determined after their last cycle of treatment received.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Baseline and then every 4 weeks until week 24
Results posted on
2018-01-02
Participant Flow
Participant milestones
| Measure |
Treatment (Biological Therapy, Chemo)
Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
imiquimod: Given topically
Abraxane: Given IV
laboratory biomarker analysis: Correlative studies
RNA analysis: Correlative studies
immunoenzyme technique: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
Evaluable for Clinical Response
|
14
|
|
Overall Study
Evaluable for Pathologic Response
|
7
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topical Imiquimod and Abraxane in Treating Patients With Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Biological Therapy, Chemo)
n=15 Participants
Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
imiquimod: Given topically
Abraxane: Given IV
laboratory biomarker analysis: Correlative studies
RNA analysis: Correlative studies
immunoenzyme technique: Correlative studies
|
|---|---|
|
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
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 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
|
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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and then every 4 weeks until week 24Tumor responses will be determined using the sum of the products of the largest perpendicular dimensions. Target lesions will be evaluated by the following response criteria: complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). Evaluation of target lesions per modified WHO response criteria: * Complete response (CR): complete clearance (100%) of target lesion(s) * Partial response (PR): ≥ 50% decrease in target lesion size * Stable disease (SD): \< 50% decrease in target lesion size * Progressive (PD): ≥ 25% increase in target lesion size Overall Response Rate (ORR) determined at end of study treatment which was 1 week after cycle #3, unless patient was withdrawn from study. If patient was withdrawn from study, then ORR was determined after their last cycle of treatment received.
Outcome measures
| Measure |
Treatment (Biological Therapy, Chemo)
n=14 Participants
Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
imiquimod: Given topically
Abraxane: Given IV
laboratory biomarker analysis: Correlative studies
RNA analysis: Correlative studies
immunoenzyme technique: Correlative studies
|
HER2, IGFBP-2, MAGE3, Topo IIa Antigen - Baseline to Week 24
Precursor frequency of HER2, IGFBP-2, MAGE3, Topo IIa Antigen - Baseline to Week 24
|
|---|---|---|
|
Anti-tumor Effects of Imiquimod as Assessed by Modified World Health Organization (WHO) Criteria
Total Evaluated in this Outcome Measure
|
14 Participants
|
—
|
|
Anti-tumor Effects of Imiquimod as Assessed by Modified World Health Organization (WHO) Criteria
Complete Response (CR)
|
5 Participants
|
—
|
|
Anti-tumor Effects of Imiquimod as Assessed by Modified World Health Organization (WHO) Criteria
Partial Response (PR)
|
5 Participants
|
—
|
|
Anti-tumor Effects of Imiquimod as Assessed by Modified World Health Organization (WHO) Criteria
Stable Disease (SD)
|
3 Participants
|
—
|
|
Anti-tumor Effects of Imiquimod as Assessed by Modified World Health Organization (WHO) Criteria
Progressive Disease (PD)
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline and weeks 5, 9 13, 16, 20, and 24Evaluated according to the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 and monitoring of adverse events will be done per Food and Drug Administration (FDA) and National Cancer Institute (NCI) guidelines for the time frame below. Number of Participants with at Least 1 Adverse Event as Assessed by a Review of Medical History, Physical Exam, Systems, Performance Status, and Clinical Labs (CBC and CMP) under the following CTCAE categories: Constitutional (Fatigue) Neurological (Neuropathy (sensory or motor)) Cardiac (Arrhythemia) Pulmonary (Cough, Pharyngitis) GI (Constipation, Diarrhea, Mucositis, Vomiting) Dermatology (Ulceration, Hairloss/alopecia) Pain (Headache, other pain) Syndrome (Flu-like) Visual Changes Hearing/Auditory Edema Other (General) In addition they were asked the severity of the event so that a clinician could grade the event.
Outcome measures
| Measure |
Treatment (Biological Therapy, Chemo)
n=15 Participants
Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
imiquimod: Given topically
Abraxane: Given IV
laboratory biomarker analysis: Correlative studies
RNA analysis: Correlative studies
immunoenzyme technique: Correlative studies
|
HER2, IGFBP-2, MAGE3, Topo IIa Antigen - Baseline to Week 24
Precursor frequency of HER2, IGFBP-2, MAGE3, Topo IIa Antigen - Baseline to Week 24
|
|---|---|---|
|
Safety and Systemic Toxicity as Assessed by a Review of Medical History, Physical Exam, Systems, Performance Status, and Clinical Labs (CBC and CMP)
|
15 Participants
|
—
|
PRIMARY outcome
Timeframe: Pre-and post-treatmentThis is done by IHC staining reviewed by a pathologist. This is done by comparing the baseline to the post-treatment biopsy tissue. Yes equals absence of residual disease.
Outcome measures
| Measure |
Treatment (Biological Therapy, Chemo)
n=7 Participants
Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
imiquimod: Given topically
Abraxane: Given IV
laboratory biomarker analysis: Correlative studies
RNA analysis: Correlative studies
immunoenzyme technique: Correlative studies
|
HER2, IGFBP-2, MAGE3, Topo IIa Antigen - Baseline to Week 24
Precursor frequency of HER2, IGFBP-2, MAGE3, Topo IIa Antigen - Baseline to Week 24
|
|---|---|---|
|
Pathologic Response by Immunohistochemical (IHC)as Assessed by Skin Punch Biopsy of the Target Lesion
Total Number of Evaluable for Pathologic Response
|
7 Participants
|
—
|
|
Pathologic Response by Immunohistochemical (IHC)as Assessed by Skin Punch Biopsy of the Target Lesion
Evaluable Pts. with Pathologic Response Post Tx
|
5 Participants
|
—
|
|
Pathologic Response by Immunohistochemical (IHC)as Assessed by Skin Punch Biopsy of the Target Lesion
Evaluable Pts. without Pathologic Response Post Tx
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and at weeks 13 and 24Peripheral blood will be obtained at baseline, after cycle 3 (end of study treatment) and at week 24 (end of study) to assess the immune response. A positive antigen-specific T cell immune response will be defined as a T cell precursor frequency more robust than 1:20,000 PBMC if the patients did not have a detectable response prior to treatment. In patients with a pre-existent immune response, the development of an immune response twice baseline will constitute augmentation.
Outcome measures
| Measure |
Treatment (Biological Therapy, Chemo)
n=8 Participants
Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
imiquimod: Given topically
Abraxane: Given IV
laboratory biomarker analysis: Correlative studies
RNA analysis: Correlative studies
immunoenzyme technique: Correlative studies
|
HER2, IGFBP-2, MAGE3, Topo IIa Antigen - Baseline to Week 24
n=3 Participants
Precursor frequency of HER2, IGFBP-2, MAGE3, Topo IIa Antigen - Baseline to Week 24
|
|---|---|---|
|
Endogenous Immunity to Common Breast Tumor Antigens (HER2, IGFBP-2, Topoisomerase II-alpha, and p53) in Peripheral Blood as Assessed by IFN-gamma and ELISPOT Assay
HER2 Antigen · Positive antigen-specific T cell immune response
|
0 Participants
|
0 Participants
|
|
Endogenous Immunity to Common Breast Tumor Antigens (HER2, IGFBP-2, Topoisomerase II-alpha, and p53) in Peripheral Blood as Assessed by IFN-gamma and ELISPOT Assay
HER2 Antigen · Negative antigen specific T cell immune response
|
8 Participants
|
3 Participants
|
|
Endogenous Immunity to Common Breast Tumor Antigens (HER2, IGFBP-2, Topoisomerase II-alpha, and p53) in Peripheral Blood as Assessed by IFN-gamma and ELISPOT Assay
IGFBP-2 Antigen · Positive antigen-specific T cell immune response
|
2 Participants
|
1 Participants
|
|
Endogenous Immunity to Common Breast Tumor Antigens (HER2, IGFBP-2, Topoisomerase II-alpha, and p53) in Peripheral Blood as Assessed by IFN-gamma and ELISPOT Assay
IGFBP-2 Antigen · Negative antigen specific T cell immune response
|
6 Participants
|
2 Participants
|
|
Endogenous Immunity to Common Breast Tumor Antigens (HER2, IGFBP-2, Topoisomerase II-alpha, and p53) in Peripheral Blood as Assessed by IFN-gamma and ELISPOT Assay
MAGE3 Antigen · Positive antigen-specific T cell immune response
|
5 Participants
|
1 Participants
|
|
Endogenous Immunity to Common Breast Tumor Antigens (HER2, IGFBP-2, Topoisomerase II-alpha, and p53) in Peripheral Blood as Assessed by IFN-gamma and ELISPOT Assay
MAGE3 Antigen · Negative antigen specific T cell immune response
|
3 Participants
|
2 Participants
|
|
Endogenous Immunity to Common Breast Tumor Antigens (HER2, IGFBP-2, Topoisomerase II-alpha, and p53) in Peripheral Blood as Assessed by IFN-gamma and ELISPOT Assay
TopoII-alpha Antigen · Positive antigen-specific T cell immune response
|
2 Participants
|
0 Participants
|
|
Endogenous Immunity to Common Breast Tumor Antigens (HER2, IGFBP-2, Topoisomerase II-alpha, and p53) in Peripheral Blood as Assessed by IFN-gamma and ELISPOT Assay
TopoII-alpha Antigen · Negative antigen specific T cell immune response
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and at weeks 13Incidence of reduction of serum TGF-beta levels as assessed by ELISA and correlation with Th1 adaptive immunity and clinical response is defined as a reduction of at least 25% from baseline value to the value measured at week 13.
Outcome measures
| Measure |
Treatment (Biological Therapy, Chemo)
n=8 Participants
Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
imiquimod: Given topically
Abraxane: Given IV
laboratory biomarker analysis: Correlative studies
RNA analysis: Correlative studies
immunoenzyme technique: Correlative studies
|
HER2, IGFBP-2, MAGE3, Topo IIa Antigen - Baseline to Week 24
Precursor frequency of HER2, IGFBP-2, MAGE3, Topo IIa Antigen - Baseline to Week 24
|
|---|---|---|
|
Incidence of Reduction of Serum TGF-beta Levels as Assessed by ELISA and Correlation With Th1 Adaptive Immunity and Clinical Response
No incidence of 25% reduction of TGF-beta at week1
|
8 Participants
|
—
|
|
Incidence of Reduction of Serum TGF-beta Levels as Assessed by ELISA and Correlation With Th1 Adaptive Immunity and Clinical Response
Incidence of 25% reduction of TGF-beta at week 13
|
0 Participants
|
—
|
Adverse Events
Treatment (Biological Therapy, Chemo)
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Biological Therapy, Chemo)
n=15 participants at risk
Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
imiquimod: Given topically
Abraxane: Given IV
laboratory biomarker analysis: Correlative studies
RNA analysis: Correlative studies
immunoenzyme technique: Correlative studies
|
|---|---|
|
General disorders
Pain
|
6.7%
1/15 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Biological Therapy, Chemo)
n=15 participants at risk
Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
imiquimod: Given topically
Abraxane: Given IV
laboratory biomarker analysis: Correlative studies
RNA analysis: Correlative studies
immunoenzyme technique: Correlative studies
|
|---|---|
|
Investigations
ANC/AGC High
|
13.3%
2/15 • Number of events 2
|
|
Blood and lymphatic system disorders
Other - Low HCT
|
73.3%
11/15 • Number of events 23
|
|
Blood and lymphatic system disorders
Other - High immature granulocytes
|
46.7%
7/15 • Number of events 13
|
|
Blood and lymphatic system disorders
Other - Low immuature granulocytes
|
6.7%
1/15 • Number of events 1
|
|
Blood and lymphatic system disorders
Other - High MCH
|
6.7%
1/15 • Number of events 1
|
|
Blood and lymphatic system disorders
Other - Low MCHC
|
26.7%
4/15 • Number of events 8
|
|
Blood and lymphatic system disorders
Other High MCV
|
20.0%
3/15 • Number of events 8
|
|
Blood and lymphatic system disorders
Other - High monocytes
|
6.7%
1/15 • Number of events 2
|
|
Blood and lymphatic system disorders
Other - Low RBC
|
53.3%
8/15 • Number of events 14
|
|
Blood and lymphatic system disorders
Others - High RDWCV
|
26.7%
4/15 • Number of events 5
|
|
Blood and lymphatic system disorders
Anemia
|
86.7%
13/15 • Number of events 28
|
|
Blood and lymphatic system disorders
Lymphopenia
|
73.3%
11/15 • Number of events 23
|
|
Blood and lymphatic system disorders
Leukocytes High
|
6.7%
1/15 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
86.7%
13/15 • Number of events 37
|
|
Blood and lymphatic system disorders
Neutropenia
|
53.3%
8/15 • Number of events 17
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.3%
2/15 • Number of events 2
|
|
General disorders
Fatigue
|
46.7%
7/15 • Number of events 12
|
|
General disorders
Sweating (diaphoresis)
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Weight Loss
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia (scalp or body)
|
73.3%
11/15 • Number of events 12
|
|
General disorders
Nail Changes
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus/Itching
|
6.7%
1/15 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
20.0%
3/15 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Rash: Acne/Acneiform
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash: Hand-Foot Skin Reaction
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
53.3%
8/15 • Number of events 11
|
|
Gastrointestinal disorders
Constipation
|
26.7%
4/15 • Number of events 7
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
26.7%
4/15 • Number of events 6
|
|
Gastrointestinal disorders
Mucositis/Stomatitis
|
20.0%
3/15 • Number of events 3
|
|
Gastrointestinal disorders
Mucositis/Stromatitis
|
13.3%
2/15 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
46.7%
7/15 • Number of events 13
|
|
Gastrointestinal disorders
Vomiting
|
26.7%
4/15 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Nose Bleeds
|
6.7%
1/15 • Number of events 2
|
|
Vascular disorders
Edema: Limb
|
13.3%
2/15 • Number of events 3
|
|
Investigations
Alkaline Phosphatase
|
20.0%
3/15 • Number of events 3
|
|
Investigations
ALT/ SGPT High
|
13.3%
2/15 • Number of events 2
|
|
Investigations
AST/SGOT High
|
6.7%
1/15 • Number of events 2
|
|
Investigations
AST/SGOT Low
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Creatinine High
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Creatinine Low
|
6.7%
1/15 • Number of events 1
|
|
Investigations
GFR Low
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.7%
1/15 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
5/15 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.7%
1/15 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
5/15 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.7%
1/15 • Number of events 1
|
|
Investigations
BUN High
|
20.0%
3/15 • Number of events 3
|
|
Investigations
BUN Low
|
13.3%
2/15 • Number of events 2
|
|
Investigations
Chloride High
|
13.3%
2/15 • Number of events 2
|
|
Investigations
Ion gap high
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Protein Low
|
13.3%
2/15 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
20.0%
3/15 • Number of events 3
|
|
Nervous system disorders
Neuropathy: Motor
|
13.3%
2/15 • Number of events 2
|
|
Nervous system disorders
Neuropathy: Sensory
|
60.0%
9/15 • Number of events 13
|
|
Eye disorders
Ocular/Visual Other
|
6.7%
1/15 • Number of events 1
|
|
Eye disorders
Blurred Vision
|
6.7%
1/15 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Headache
|
40.0%
6/15 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.3%
2/15 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain (unspecified)
|
20.0%
3/15 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Shoulder (right) - muscular/bony
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
40.0%
6/15 • Number of events 10
|
|
Cardiac disorders
Hypertension
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Psoriasis-like rash
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Distension/Bloating, abdominal
|
6.7%
1/15 • Number of events 1
|
|
Injury, poisoning and procedural complications
Seroma Axillary on Right Side
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Beta-Hemolytic Streptococcus Bacteria
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Renal Pyelonephritis
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Upper Respiratory Infection
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Axilla (left)
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Axilla (right), shoulder, lateral back
|
6.7%
1/15 • Number of events 1
|
|
Reproductive system and breast disorders
Pain - Breast
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Pain - Chest, Noncardiac
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
2/15 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place