Trial Outcomes & Findings for Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer (NCT NCT00843726)
NCT ID: NCT00843726
Last Updated: 2021-06-15
Results Overview
Count of patients experiencing at least one grade 3 or higher adverse event. The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 is used for assessing the adverse events. High grades AEs are considered worse.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
98 participants
Primary outcome timeframe
1year
Results posted on
2021-06-15
Participant Flow
Participant milestones
| Measure |
1 High-dose Fraction SBRT
Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).
stereotactic body radiation therapy: Patients undergo 1 high-dose fraction
|
3 High-dose Fractions SBRT
Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.
stereotactic body radiation therapy: Patients undergo 3 high-dose fractions
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
49
|
|
Overall Study
COMPLETED
|
48
|
48
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
1 High-dose Fraction SBRT
Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).
stereotactic body radiation therapy: Patients undergo 1 high-dose fraction
|
3 High-dose Fractions SBRT
Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.
stereotactic body radiation therapy: Patients undergo 3 high-dose fractions
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
1 High-dose Fraction SBRT
n=49 Participants
Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).
stereotactic body radiation therapy: Patients undergo 1 high-dose fraction
|
3 High-dose Fractions SBRT
n=49 Participants
Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.
stereotactic body radiation therapy: Patients undergo 3 high-dose fractions
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
45 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Age, Continuous
|
76.5 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
74.5 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
75.5 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1yearPopulation: All treated and eligible patients
Count of patients experiencing at least one grade 3 or higher adverse event. The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 is used for assessing the adverse events. High grades AEs are considered worse.
Outcome measures
| Measure |
I High-dose Fraction SBRT
n=49 Participants
Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).
stereotactic body radiation therapy: Patients undergo 1 high-dose fraction
|
3 High-dose Fractions SBRT
n=49 Participants
Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.
stereotactic body radiation therapy: Patients undergo 3 high-dose fractions
|
|---|---|---|
|
Incidence of AE Grade 3 or Higher Toxicity
|
24 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: All treated and eligible patients
Median overall survival
Outcome measures
| Measure |
I High-dose Fraction SBRT
n=49 Participants
Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).
stereotactic body radiation therapy: Patients undergo 1 high-dose fraction
|
3 High-dose Fractions SBRT
n=49 Participants
Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.
stereotactic body radiation therapy: Patients undergo 3 high-dose fractions
|
|---|---|---|
|
Overall Survival
|
39.0 months
Interval 27.2 to 51.9
|
38.3 months
Interval 21.1 to 49.0
|
PRIMARY outcome
Timeframe: 4 yearsPopulation: Data was not collected for this outcome
Outcome measures
Outcome data not reported
Adverse Events
1 High-dose Fraction SBRT
Serious events: 2 serious events
Other events: 38 other events
Deaths: 33 deaths
3 High-dose Fractions SBRT
Serious events: 5 serious events
Other events: 36 other events
Deaths: 29 deaths
Serious adverse events
| Measure |
1 High-dose Fraction SBRT
n=49 participants at risk
Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).
stereotactic body radiation therapy: Patients undergo 1 high-dose fraction
|
3 High-dose Fractions SBRT
n=49 participants at risk
Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.
stereotactic body radiation therapy: Patients undergo 3 high-dose fractions
|
|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Infections and infestations
Lung infection
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 2 • Baseline, weekly until 30 day follow-up.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Nervous system disorders
Syncope
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
Other adverse events
| Measure |
1 High-dose Fraction SBRT
n=49 participants at risk
Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).
stereotactic body radiation therapy: Patients undergo 1 high-dose fraction
|
3 High-dose Fractions SBRT
n=49 participants at risk
Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.
stereotactic body radiation therapy: Patients undergo 3 high-dose fractions
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.1%
2/49 • Number of events 2 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Ear and labyrinth disorders
Deafness
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Ear and labyrinth disorders
Vertigo
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 2 • Baseline, weekly until 30 day follow-up.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.1%
2/49 • Number of events 2 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Gastrointestinal disorders
Dysphagia
|
4.1%
2/49 • Number of events 2 • Baseline, weekly until 30 day follow-up.
|
6.1%
3/49 • Number of events 3 • Baseline, weekly until 30 day follow-up.
|
|
Gastrointestinal disorders
Haematochezia
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Gastrointestinal disorders
Nausea
|
6.1%
3/49 • Number of events 3 • Baseline, weekly until 30 day follow-up.
|
8.2%
4/49 • Number of events 4 • Baseline, weekly until 30 day follow-up.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
6.1%
3/49 • Number of events 3 • Baseline, weekly until 30 day follow-up.
|
|
General disorders
Asthenia
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
General disorders
Chest discomfort
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
General disorders
Chest pain
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
6.1%
3/49 • Number of events 5 • Baseline, weekly until 30 day follow-up.
|
|
General disorders
Chills
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
General disorders
Disease progression
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
General disorders
Fatigue
|
36.7%
18/49 • Number of events 21 • Baseline, weekly until 30 day follow-up.
|
42.9%
21/49 • Number of events 22 • Baseline, weekly until 30 day follow-up.
|
|
General disorders
Oedema peripheral
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
General disorders
Pain
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
General disorders
Pyrexia
|
2.0%
1/49 • Number of events 2 • Baseline, weekly until 30 day follow-up.
|
4.1%
2/49 • Number of events 2 • Baseline, weekly until 30 day follow-up.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
4.1%
2/49 • Number of events 2 • Baseline, weekly until 30 day follow-up.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Infections and infestations
Orchitis
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Infections and infestations
Pneumonia
|
6.1%
3/49 • Number of events 4 • Baseline, weekly until 30 day follow-up.
|
6.1%
3/49 • Number of events 3 • Baseline, weekly until 30 day follow-up.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Infections and infestations
Sinusitis
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
4.1%
2/49 • Number of events 2 • Baseline, weekly until 30 day follow-up.
|
|
Infections and infestations
Urinary tract infection
|
4.1%
2/49 • Number of events 2 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Injury, poisoning and procedural complications
Contusion
|
4.1%
2/49 • Number of events 2 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
4.1%
2/49 • Number of events 2 • Baseline, weekly until 30 day follow-up.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 2 • Baseline, weekly until 30 day follow-up.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Investigations
Weight decreased
|
6.1%
3/49 • Number of events 3 • Baseline, weekly until 30 day follow-up.
|
8.2%
4/49 • Number of events 4 • Baseline, weekly until 30 day follow-up.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.1%
3/49 • Number of events 4 • Baseline, weekly until 30 day follow-up.
|
8.2%
4/49 • Number of events 4 • Baseline, weekly until 30 day follow-up.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
8.2%
4/49 • Number of events 5 • Baseline, weekly until 30 day follow-up.
|
4.1%
2/49 • Number of events 2 • Baseline, weekly until 30 day follow-up.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 2 • Baseline, weekly until 30 day follow-up.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
6.1%
3/49 • Number of events 3 • Baseline, weekly until 30 day follow-up.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Nervous system disorders
Dementia
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Nervous system disorders
Dizziness
|
4.1%
2/49 • Number of events 2 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Nervous system disorders
Tremor
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Psychiatric disorders
Confusional state
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Psychiatric disorders
Depression
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Psychiatric disorders
Hallucination
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
4.1%
2/49 • Number of events 2 • Baseline, weekly until 30 day follow-up.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Renal and urinary disorders
Micturition urgency
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Renal and urinary disorders
Pollakiuria
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.3%
8/49 • Number of events 8 • Baseline, weekly until 30 day follow-up.
|
8.2%
4/49 • Number of events 4 • Baseline, weekly until 30 day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
26.5%
13/49 • Number of events 16 • Baseline, weekly until 30 day follow-up.
|
22.4%
11/49 • Number of events 12 • Baseline, weekly until 30 day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
6.1%
3/49 • Number of events 3 • Baseline, weekly until 30 day follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.1%
2/49 • Number of events 2 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
4.1%
2/49 • Number of events 2 • Baseline, weekly until 30 day follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Vascular disorders
Haematoma
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
|
Vascular disorders
Hypertension
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
2.0%
1/49 • Number of events 1 • Baseline, weekly until 30 day follow-up.
|
|
Vascular disorders
Hypotension
|
4.1%
2/49 • Number of events 2 • Baseline, weekly until 30 day follow-up.
|
0.00%
0/49 • Baseline, weekly until 30 day follow-up.
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 7168451300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place