Trial Outcomes & Findings for Regorafenib and Methotrexate in Treating Participants With Recurrent or Metastatic KRAS Mutated Non-Small Cell Lung Cancer (NCT NCT03520842)
NCT ID: NCT03520842
Last Updated: 2023-08-01
Results Overview
Progression free survival (PFS), measured from time of first study treatment until objective tumor progression as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria or death from any cause, whichever occurs earlier. PFS was calculated using the Kaplan-Meier method along with 95% confidence interval. RECIST v1.1 criteria are: * Complete Response (CR) = Disappearance of all target lesions * Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions * Overall Response (OR) = CR + PR * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) * Stable disease (SD) = Small changes that do not meet any of the above criteria
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
From first study treatment assessed up to 15 months
Results posted on
2023-08-01
Participant Flow
22 patients signed consent, 18 were allocated to treatment.
Participant milestones
| Measure |
Treatment (Regorafenib, Methotrexate)
Participants receive regorafenib PO once daily (QD) on days 1-21, and methotrexate PO twice weekly with 2-3 days apart on a 3 week on/ 1 week off cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Regorafenib and Methotrexate in Treating Participants With Recurrent or Metastatic KRAS Mutated Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Regorafenib, Methotrexate)
n=18 Participants
Participants receive regorafenib PO QD on days 1-21, and methotrexate PO twice weekly with 2-3 days apart on a 3 week on/ 1 week off cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
68.9 years
STANDARD_DEVIATION 7.7 • n=39 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=39 Participants
|
|
Smoking Status
Never
|
4 Participants
n=39 Participants
|
|
Smoking Status
Former
|
14 Participants
n=39 Participants
|
|
ECOG Performance Status
0
|
2 Participants
n=39 Participants
|
|
ECOG Performance Status
1
|
16 Participants
n=39 Participants
|
|
Disease Presentation
Recurrent
|
11 Participants
n=39 Participants
|
|
Disease Presentation
Metastatic
|
7 Participants
n=39 Participants
|
|
History of Pleural Effusion
Yes
|
9 Participants
n=39 Participants
|
|
History of Pleural Effusion
No
|
9 Participants
n=39 Participants
|
|
Brain Metastases
Previously treated
|
3 Participants
n=39 Participants
|
|
Brain Metastases
Untreated stable
|
1 Participants
n=39 Participants
|
|
Brain Metastases
None
|
14 Participants
n=39 Participants
|
|
Tumor Histology: Adenocarcinoma
|
18 Participants
n=39 Participants
|
|
KRAS Mutation Subtype
G12C
|
5 Participants
n=39 Participants
|
|
KRAS Mutation Subtype
G12D
|
6 Participants
n=39 Participants
|
|
KRAS Mutation Subtype
G12R
|
2 Participants
n=39 Participants
|
|
KRAS Mutation Subtype
G12V
|
2 Participants
n=39 Participants
|
|
KRAS Mutation Subtype
Q61L
|
1 Participants
n=39 Participants
|
|
KRAS Mutation Subtype
G12C/K117N
|
1 Participants
n=39 Participants
|
|
KRAS Mutation Subtype
G12S/A146V
|
1 Participants
n=39 Participants
|
|
Previous Lines of Systemic Therapy
1
|
10 Participants
n=39 Participants
|
|
Previous Lines of Systemic Therapy
2-3
|
5 Participants
n=39 Participants
|
|
Previous Lines of Systemic Therapy
4-5
|
3 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: From first study treatment assessed up to 15 monthsProgression free survival (PFS), measured from time of first study treatment until objective tumor progression as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria or death from any cause, whichever occurs earlier. PFS was calculated using the Kaplan-Meier method along with 95% confidence interval. RECIST v1.1 criteria are: * Complete Response (CR) = Disappearance of all target lesions * Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions * Overall Response (OR) = CR + PR * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) * Stable disease (SD) = Small changes that do not meet any of the above criteria
Outcome measures
| Measure |
Treatment (Regorafenib, Methotrexate)
n=18 Participants
Participants receive regorafenib PO QD on days 1-21, and methotrexate PO twice weekly with 2-3 days apart on a 3 week on/ 1 week off cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Progression Free Survival (PFS)
|
3.7 months
Interval 1.8 to 8.6
|
SECONDARY outcome
Timeframe: Up to 24 monthsObjective response rate (ORR; as determined by RECIST v1.1) will be assessed as the proportion (percent) of participants with either complete response (CR; disappearance of all target lesions) or partial response (PR; ≥ 30% decrease in the sum of the longest diameter of target lesions), with exact 95% confidence intervals based on a binomial distribution.
Outcome measures
| Measure |
Treatment (Regorafenib, Methotrexate)
n=18 Participants
Participants receive regorafenib PO QD on days 1-21, and methotrexate PO twice weekly with 2-3 days apart on a 3 week on/ 1 week off cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Objective Response Rate (ORR)
|
16.7 percentage of participants
Interval 3.5 to 41.4
|
SECONDARY outcome
Timeframe: At 8 weeksDisease control rate (DCR) will be assessed as the proportion of complete responses (CR) + partial responses (PR) + stable disease (SD) after 8 weeks of treatment (+/- 1 week), as determined by using RECIST v1.1
Outcome measures
| Measure |
Treatment (Regorafenib, Methotrexate)
n=18 Participants
Participants receive regorafenib PO QD on days 1-21, and methotrexate PO twice weekly with 2-3 days apart on a 3 week on/ 1 week off cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Disease Control Rate (DCR)
|
66.7 percentage of participants
Interval 41.0 to 86.7
|
SECONDARY outcome
Timeframe: Up to 38 monthsParticipants who experienced any treatment emergent adverse event and any ≥ grade 3 adverse event is reported.
Outcome measures
| Measure |
Treatment (Regorafenib, Methotrexate)
n=18 Participants
Participants receive regorafenib PO QD on days 1-21, and methotrexate PO twice weekly with 2-3 days apart on a 3 week on/ 1 week off cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Participants With Adverse Events
Any grade
|
17 Participants
|
|
Number of Participants With Adverse Events
≥ grade 3
|
14 Participants
|
SECONDARY outcome
Timeframe: Cycle 1, Days 1, 8, 15, and 22Pharmacokinetics (PK) of methotrexate when co-administered with regorafenib, as indicated by the trough serum concentration, was accessed by a fluorescent polarization immunoassay, and is reported as the mean with standard deviation. Participants treated with at least 1 dose of regorafenib and methotrexate and with at least one evaluable baseline pharmacokinetic sample and one follow up trough pharmacokinetic sample treated were included.
Outcome measures
| Measure |
Treatment (Regorafenib, Methotrexate)
n=18 Participants
Participants receive regorafenib PO QD on days 1-21, and methotrexate PO twice weekly with 2-3 days apart on a 3 week on/ 1 week off cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Trough Serum Concentration of Methotrexate
Cycle 1, Day 1
|
0.04 μmol/L
Standard Deviation 0.02
|
|
Trough Serum Concentration of Methotrexate
Cycle 1, Day 8
|
0.04 μmol/L
Standard Deviation 0.01
|
|
Trough Serum Concentration of Methotrexate
Cycle 1, Day 15
|
0.05 μmol/L
Standard Deviation 0.03
|
|
Trough Serum Concentration of Methotrexate
Cycle 1, Day 22
|
0.05 μmol/L
Standard Deviation 0.02
|
SECONDARY outcome
Timeframe: Cycle 1, Days 1, 8, and 15Pharmacokinetics (PK) of methotrexate when co-administered with regorafenib, as indicated by the maximum serum concentration (Cmax) of methotrexate, was assessed by a fluorescent polarization immunoassay, and is reported as the mean with standard deviation. Participants treated with at least 1 dose of regorafenib and methotrexate and with at least one evaluable Cmax pharmacokinetic sample were included in the assessment.
Outcome measures
| Measure |
Treatment (Regorafenib, Methotrexate)
n=18 Participants
Participants receive regorafenib PO QD on days 1-21, and methotrexate PO twice weekly with 2-3 days apart on a 3 week on/ 1 week off cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Maximum Serum Concentration (Cmax) of Methotrexate
Cycle 1, Day 1
|
0.43 μmol/L
Standard Deviation 0.23
|
|
Maximum Serum Concentration (Cmax) of Methotrexate
Cycle 1, Day 8
|
0.60 μmol/L
Standard Deviation 0.30
|
|
Maximum Serum Concentration (Cmax) of Methotrexate
Cycle 1, Day 15
|
0.60 μmol/L
Standard Deviation 0.43
|
Adverse Events
Treatment (Regorafenib, Methotrexate)
Serious events: 8 serious events
Other events: 17 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Treatment (Regorafenib, Methotrexate)
n=18 participants at risk
Participants receive regorafenib PO QD on days 1-21, and methotrexate PO twice weekly with 2-3 days apart on a 3 week on/ 1 week off cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
5.6%
1/18 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
3/18 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.1%
2/18 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.6%
1/18 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
5.6%
1/18 • Up to 38 months
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
1/18 • Up to 38 months
|
|
Vascular disorders
Thromboembolic event: pulmonary embolism
|
5.6%
1/18 • Up to 38 months
|
|
Cardiac disorders
Atrial fibrillation
|
5.6%
1/18 • Up to 38 months
|
|
Gastrointestinal disorders
Pancreatitis
|
5.6%
1/18 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
5.6%
1/18 • Up to 38 months
|
Other adverse events
| Measure |
Treatment (Regorafenib, Methotrexate)
n=18 participants at risk
Participants receive regorafenib PO QD on days 1-21, and methotrexate PO twice weekly with 2-3 days apart on a 3 week on/ 1 week off cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
1/18 • Up to 38 months
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
3/18 • Up to 38 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
22.2%
4/18 • Up to 38 months
|
|
Investigations
Amylase increased
|
16.7%
3/18 • Up to 38 months
|
|
Metabolism and nutrition disorders
Anorexia
|
44.4%
8/18 • Up to 38 months
|
|
Blood and lymphatic system disorders
Anemia
|
5.6%
1/18 • Up to 38 months
|
|
Psychiatric disorders
Anxiety
|
5.6%
1/18 • Up to 38 months
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
3/18 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
5.6%
1/18 • Up to 38 months
|
|
Cardiac disorders
Atrial fibrillation
|
5.6%
1/18 • Up to 38 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
3/18 • Up to 38 months
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
5.6%
1/18 • Up to 38 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.6%
1/18 • Up to 38 months
|
|
Investigations
Blood bilirubin increased
|
11.1%
2/18 • Up to 38 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.6%
1/18 • Up to 38 months
|
|
Injury, poisoning and procedural complications
Bruising
|
5.6%
1/18 • Up to 38 months
|
|
Cardiac disorders
Cardiomyopathy
|
5.6%
1/18 • Up to 38 months
|
|
Cardiac disorders
Tachycardia
|
5.6%
1/18 • Up to 38 months
|
|
General disorders
Chills
|
5.6%
1/18 • Up to 38 months
|
|
Gastrointestinal disorders
Colitis
|
5.6%
1/18 • Up to 38 months
|
|
Nervous system disorders
Concentration impairment
|
5.6%
1/18 • Up to 38 months
|
|
Gastrointestinal disorders
Constipation
|
22.2%
4/18 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
3/18 • Up to 38 months
|
|
Investigations
Creatinine increased
|
5.6%
1/18 • Up to 38 months
|
|
Psychiatric disorders
Delirium
|
5.6%
1/18 • Up to 38 months
|
|
Gastrointestinal disorders
Diarrhea
|
27.8%
5/18 • Up to 38 months
|
|
Nervous system disorders
Dizziness
|
16.7%
3/18 • Up to 38 months
|
|
Eye disorders
Dry eye
|
5.6%
1/18 • Up to 38 months
|
|
Gastrointestinal disorders
Dry mouth
|
5.6%
1/18 • Up to 38 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.1%
2/18 • Up to 38 months
|
|
Nervous system disorders
Dysgeusia
|
16.7%
3/18 • Up to 38 months
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
3/18 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
9/18 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
3/18 • Up to 38 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
5.6%
1/18 • Up to 38 months
|
|
Gastrointestinal disorders
Esophageal stenosis
|
5.6%
1/18 • Up to 38 months
|
|
Gastrointestinal disorders
Esophagitis
|
5.6%
1/18 • Up to 38 months
|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
1/18 • Up to 38 months
|
|
General disorders
Fatigue
|
50.0%
9/18 • Up to 38 months
|
|
Gastrointestinal disorders
Fecal incontinence
|
5.6%
1/18 • Up to 38 months
|
|
General disorders
Fever
|
5.6%
1/18 • Up to 38 months
|
|
General disorders
Flu like symptoms
|
5.6%
1/18 • Up to 38 months
|
|
Injury, poisoning and procedural complications
Fracture
|
5.6%
1/18 • Up to 38 months
|
|
Gastrointestinal disorders
Gastroesphogeal reflux disease
|
11.1%
2/18 • Up to 38 months
|
|
Gastrointestinal disorders
Gas Pain (chest)
|
5.6%
1/18 • Up to 38 months
|
|
General disorders
Hyperhidrosis
|
5.6%
1/18 • Up to 38 months
|
|
General disorders
Bleeding gums
|
5.6%
1/18 • Up to 38 months
|
|
Nervous system disorders
Headache
|
16.7%
3/18 • Up to 38 months
|
|
Nervous system disorders
Hiccups
|
5.6%
1/18 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
38.9%
7/18 • Up to 38 months
|
|
Vascular disorders
Hot flashes
|
5.6%
1/18 • Up to 38 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.6%
1/18 • Up to 38 months
|
|
Vascular disorders
Hypertension
|
27.8%
5/18 • Up to 38 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.6%
1/18 • Up to 38 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.1%
2/18 • Up to 38 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
3/18 • Up to 38 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
27.8%
5/18 • Up to 38 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
50.0%
9/18 • Up to 38 months
|
|
Vascular disorders
Hypotension
|
11.1%
2/18 • Up to 38 months
|
|
Endocrine disorders
Hypothyroidism
|
5.6%
1/18 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.1%
2/18 • Up to 38 months
|
|
Investigations
Thyroid stimulating hormone increased
|
5.6%
1/18 • Up to 38 months
|
|
Investigations
Hyperbilirubinemia
|
5.6%
1/18 • Up to 38 months
|
|
Investigations
Lipase increased
|
16.7%
3/18 • Up to 38 months
|
|
General disorders
Localized edema
|
16.7%
3/18 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
5.6%
1/18 • Up to 38 months
|
|
Investigations
Lymphocyte count decreased
|
5.6%
1/18 • Up to 38 months
|
|
Nervous system disorders
Memory impairment
|
5.6%
1/18 • Up to 38 months
|
|
Gastrointestinal disorders
Mucositis oral
|
50.0%
9/18 • Up to 38 months
|
|
Infections and infestations
Mucosal infection
|
5.6%
1/18 • Up to 38 months
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp (bottom of feet)
|
5.6%
1/18 • Up to 38 months
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
5.6%
1/18 • Up to 38 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
27.8%
5/18 • Up to 38 months
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
5.6%
1/18 • Up to 38 months
|
|
Gastrointestinal disorders
Nausea
|
44.4%
8/18 • Up to 38 months
|
|
Nervous system disorders
Anosmia
|
5.6%
1/18 • Up to 38 months
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
16.7%
3/18 • Up to 38 months
|
|
Gastrointestinal disorders
Oral pain
|
5.6%
1/18 • Up to 38 months
|
|
General disorders
Pain
|
38.9%
7/18 • Up to 38 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erthryodysesthesia syndrome
|
44.4%
8/18 • Up to 38 months
|
|
Gastrointestinal disorders
Pancreatitis
|
5.6%
1/18 • Up to 38 months
|
|
Infections and infestations
Papulopustular rash
|
5.6%
1/18 • Up to 38 months
|
|
Nervous system disorders
Paresthesia
|
11.1%
2/18 • Up to 38 months
|
|
Infections and infestations
Paronychia
|
5.6%
1/18 • Up to 38 months
|
|
Nervous system disorders
Peripheral neuropathy
|
5.6%
1/18 • Up to 38 months
|
|
Investigations
Platelet count decreased
|
11.1%
2/18 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.6%
1/18 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.6%
1/18 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
5.6%
1/18 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.7%
3/18 • Up to 38 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
27.8%
5/18 • Up to 38 months
|
|
Vascular disorders
Pulmonary hypertension
|
5.6%
1/18 • Up to 38 months
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
11.1%
2/18 • Up to 38 months
|
|
Renal and urinary disorders
Urine output decreased
|
5.6%
1/18 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
5.6%
1/18 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
11.1%
2/18 • Up to 38 months
|
|
Cardiac disorders
Sinus tachycardia
|
5.6%
1/18 • Up to 38 months
|
|
Skin and subcutaneous tissue disorders
Tenderness
|
5.6%
1/18 • Up to 38 months
|
|
Skin and subcutaneous tissue disorders
Finger fissures
|
5.6%
1/18 • Up to 38 months
|
|
Skin and subcutaneous tissue disorders
Scrotal erosion
|
5.6%
1/18 • Up to 38 months
|
|
Skin and subcutaneous tissue disorders
Papules
|
5.6%
1/18 • Up to 38 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
1/18 • Up to 38 months
|
|
Skin and subcutaneous tissue disorders
Erythematous plaques
|
5.6%
1/18 • Up to 38 months
|
|
Skin and subcutaneous tissue disorders
Rash scalp
|
5.6%
1/18 • Up to 38 months
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis (feet)
|
5.6%
1/18 • Up to 38 months
|
|
Skin and subcutaneous tissue disorders
scalp flaking
|
5.6%
1/18 • Up to 38 months
|
|
Skin and subcutaneous tissue disorders
pustule/cyst (labia)
|
5.6%
1/18 • Up to 38 months
|
|
Skin and subcutaneous tissue disorders
erythema (nasal region/scalp)
|
5.6%
1/18 • Up to 38 months
|
|
Skin and subcutaneous tissue disorders
skin peeling/blisters (fingers, feet, toes)
|
5.6%
1/18 • Up to 38 months
|
|
Skin and subcutaneous tissue disorders
Rash (face)
|
5.6%
1/18 • Up to 38 months
|
|
Skin and subcutaneous tissue disorders
Nonpruritic rash (upper chest, shoulders, back)
|
5.6%
1/18 • Up to 38 months
|
|
Skin and subcutaneous tissue disorders
Rash (groin)
|
5.6%
1/18 • Up to 38 months
|
|
Gastrointestinal disorders
Sore throat
|
11.1%
2/18 • Up to 38 months
|
|
Gastrointestinal disorders
Stomach pain
|
11.1%
2/18 • Up to 38 months
|
|
Nervous system disorders
Syncope
|
5.6%
1/18 • Up to 38 months
|
|
Vascular disorders
Thromboembolic event
|
5.6%
1/18 • Up to 38 months
|
|
Ear and labyrinth disorders
Tinnitus
|
5.6%
1/18 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
5.6%
1/18 • Up to 38 months
|
|
Renal and urinary disorders
Urinary retention
|
5.6%
1/18 • Up to 38 months
|
|
Gastrointestinal disorders
Vomiting
|
27.8%
5/18 • Up to 38 months
|
|
Investigations
Weight loss
|
27.8%
5/18 • Up to 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.6%
1/18 • Up to 38 months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
5.6%
1/18 • Up to 38 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place