Trial Outcomes & Findings for Sulindac in Preventing Lung Cancer in Current or Former Smokers With Bronchial Dysplasia (NCT NCT00368927)
NCT ID: NCT00368927
Last Updated: 2014-05-23
Results Overview
Definition of response: complete response = regression of all dysplastic lesions (DL) to normal, hyperplasia or metaplasia with no new DL identified; partial response = regression of one or more, but not all of the DL with no new DL identified and no lesions worsening; progression = worsening at one or more sites by at least 2 histologic grades or appearance of any new DL that were not previously biopsied; stable disease = participants not classified as having a complete response, partial response, or progressive disease
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2014-05-23
Participant Flow
409 subjects were pre-registered through 6 Cancer Prevention Network (CPN) member organizations from 2006 to 2009.
346 subjects were excluded pre-assignment: 256 ineligible via sputum cytology/bronchoscopy, 37 patient/treating physician reasons, 12 comorbidities, 9 concomitant medications, 24 unable to adhere to the study timelines for tests/procedures, 8 other eligibility criteria. 2 subjects did not receive study intervention, were excluded from all analyses.
Participant milestones
| Measure |
Arm A (Sulindac)
Patients receive oral sulindac twice daily for 6 months.
|
Arm B (Placebo)
Patients receive oral placebo twice daily for 6 months.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
|
Overall Study
COMPLETED
|
26
|
27
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
Arm A (Sulindac)
Patients receive oral sulindac twice daily for 6 months.
|
Arm B (Placebo)
Patients receive oral placebo twice daily for 6 months.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Sulindac in Preventing Lung Cancer in Current or Former Smokers With Bronchial Dysplasia
Baseline characteristics by cohort
| Measure |
Arm A (Sulindac)
n=31 Participants
Patients receive oral sulindac twice daily for 6 months.
|
Arm B (Placebo)
n=30 Participants
Patients receive oral placebo twice daily for 6 months.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
60 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
16 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Body mass index
|
27.5 kg/m^2
n=5 Participants
|
28.8 kg/m^2
n=7 Participants
|
27.9 kg/m^2
n=5 Participants
|
|
Smoking status
Current
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Smoking status
Former
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Prior lung cancer
Yes
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Prior lung cancer
No
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Number of baseline dysplastic lesions
1 to 3
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Number of baseline dysplastic lesions
> 3
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: The population used for the analysis is patients completing both the pre- and post-intervention bronchoscopy.
Definition of response: complete response = regression of all dysplastic lesions (DL) to normal, hyperplasia or metaplasia with no new DL identified; partial response = regression of one or more, but not all of the DL with no new DL identified and no lesions worsening; progression = worsening at one or more sites by at least 2 histologic grades or appearance of any new DL that were not previously biopsied; stable disease = participants not classified as having a complete response, partial response, or progressive disease
Outcome measures
| Measure |
Arm A (Sulindac)
n=26 Participants
Patients receive oral sulindac twice daily for 6 months.
|
Arm B (Placebo)
n=27 Participants
Patients receive oral placebo twice daily for 6 months.
|
|---|---|---|
|
Percentage of Participants With Response Determined by Change in Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples Before and After Treatment
Stable
|
11.5 percentage of participants
|
7.4 percentage of participants
|
|
Percentage of Participants With Response Determined by Change in Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples Before and After Treatment
Complete response
|
38.5 percentage of participants
|
48.2 percentage of participants
|
|
Percentage of Participants With Response Determined by Change in Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples Before and After Treatment
Partial response
|
19.2 percentage of participants
|
7.4 percentage of participants
|
|
Percentage of Participants With Response Determined by Change in Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples Before and After Treatment
Progression
|
30.8 percentage of participants
|
37.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: The population used for the analysis is patients completing both the pre- and post- intervention bronchoscopy.
The number of dysplastic lesions was recorded pre-intervention and post-intervention for each participant in each group. Change in the number of lesions was compared between the two intervention groups.
Outcome measures
| Measure |
Arm A (Sulindac)
n=26 Participants
Patients receive oral sulindac twice daily for 6 months.
|
Arm B (Placebo)
n=27 Participants
Patients receive oral placebo twice daily for 6 months.
|
|---|---|---|
|
Percent Change in Number of Dysplastic Lesions (DL) as Measured by Mucosal Biopsy Samples Before and After the Intervention
|
-55 Percent change in number of DL
Interval -100.0 to 100.0
|
-100 Percent change in number of DL
Interval -100.0 to 200.0
|
Adverse Events
Arm A (Sulindac)
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Arm B (Placebo)
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (Sulindac)
n=31 participants at risk
Patients receive oral sulindac twice daily for 6 months.
|
Arm B (Placebo)
n=30 participants at risk
Patients receive oral placebo twice daily for 6 months.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
0.00%
0/30 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Psychiatric disorders
Depression
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
0.00%
0/30 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
Other adverse events
| Measure |
Arm A (Sulindac)
n=31 participants at risk
Patients receive oral sulindac twice daily for 6 months.
|
Arm B (Placebo)
n=30 participants at risk
Patients receive oral placebo twice daily for 6 months.
|
|---|---|---|
|
Cardiac disorders
Arrhythmia
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
0.00%
0/30 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Cardiac disorders
Cardiac disorder
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
0.00%
0/30 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/31 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/31 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Eye disorders
Diplopia
|
0.00%
0/31 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Eye disorders
Dry eye syndrome
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
0.00%
0/30 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Eye disorders
Glaucoma
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
0.00%
0/30 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Eye disorders
Vision blurred
|
0.00%
0/31 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Gastrointestinal disorders
Abdominal distension
|
9.7%
3/31 • Number of events 3 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
6.7%
2/30 • Number of events 2 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Gastrointestinal disorders
Abdominal pain
|
6.5%
2/31 • Number of events 2 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
0.00%
0/30 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/31 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Gastrointestinal disorders
Constipation
|
6.5%
2/31 • Number of events 2 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
6.7%
2/30 • Number of events 2 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Gastrointestinal disorders
Diarrhea
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
6.7%
2/30 • Number of events 2 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Gastrointestinal disorders
Dyspepsia
|
6.5%
2/31 • Number of events 2 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Gastrointestinal disorders
Flatulence
|
9.7%
3/31 • Number of events 3 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/31 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Gastrointestinal disorders
Nausea
|
6.5%
2/31 • Number of events 2 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/31 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Gastrointestinal disorders
Vomiting
|
6.5%
2/31 • Number of events 2 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
0.00%
0/30 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
General disorders
Chest pain
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
0.00%
0/30 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
General disorders
Chills
|
0.00%
0/31 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
6.7%
2/30 • Number of events 2 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
General disorders
Edema limbs
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
0.00%
0/30 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
General disorders
Fatigue
|
19.4%
6/31 • Number of events 6 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
13.3%
4/30 • Number of events 5 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
General disorders
Fever
|
0.00%
0/31 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
10.0%
3/30 • Number of events 3 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
General disorders
Flu-like symptoms
|
6.5%
2/31 • Number of events 2 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
0.00%
0/30 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
General disorders
General symptom
|
0.00%
0/31 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
General disorders
Pain
|
3.2%
1/31 • Number of events 2 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
10.0%
3/30 • Number of events 3 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Infections and infestations
Bronchitis
|
6.5%
2/31 • Number of events 2 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Infections and infestations
Sinusitis
|
0.00%
0/31 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Infections and infestations
Upper respiratory infection
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
0.00%
0/30 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Injury, poisoning and procedural complications
Fracture
|
6.5%
2/31 • Number of events 2 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
0.00%
0/30 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Injury, poisoning and procedural complications
Intraoperative musculoskeletal injury - Joint
|
0.00%
0/31 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Investigations
Alanine aminotransferase increased
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
0.00%
0/30 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Investigations
Creatinine increased
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Investigations
Leukocyte count decreased
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
0.00%
0/30 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/31 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
2/31 • Number of events 2 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
16.7%
5/30 • Number of events 5 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
3.2%
1/31 • Number of events 2 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
0.00%
0/30 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
0.00%
0/30 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/31 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
6.7%
2/30 • Number of events 2 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Nervous system disorders
Depressed level of consciousness
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
0.00%
0/30 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Nervous system disorders
Dizziness
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
6.7%
2/30 • Number of events 2 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/31 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Nervous system disorders
Headache
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
20.0%
6/30 • Number of events 6 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/31 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Nervous system disorders
Neurological disorder NOS
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.9%
4/31 • Number of events 4 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
0.00%
0/30 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Psychiatric disorders
Anxiety
|
6.5%
2/31 • Number of events 2 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
6.7%
2/30 • Number of events 2 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Psychiatric disorders
Depression
|
0.00%
0/31 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
6.7%
2/30 • Number of events 2 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Psychiatric disorders
Insomnia
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
6.7%
2/30 • Number of events 2 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/31 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/31 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Reproductive system and breast disorders
Reproductive tract disorder
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
0.00%
0/30 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.7%
3/31 • Number of events 3 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
26.7%
8/30 • Number of events 8 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/31 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
16.7%
5/30 • Number of events 6 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
10.0%
3/30 • Number of events 4 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
16.7%
5/30 • Number of events 5 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/31 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
0.00%
0/31 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
13.3%
4/30 • Number of events 4 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract hemorrhage
|
0.00%
0/31 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/31 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
0.00%
0/30 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
0.00%
0/30 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
9.7%
3/31 • Number of events 3 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
6.7%
2/30 • Number of events 2 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/31 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Skin and subcutaneous tissue disorders
Sweating
|
3.2%
1/31 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
3.3%
1/30 • Number of events 1 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
|
Vascular disorders
Hypertension
|
6.5%
2/31 • Number of events 2 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
0.00%
0/30 • Month 1 to ≤30 days after the end of intervention
CTCAE Version 3.0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60