Trial Outcomes & Findings for Combination Chemotherapy, Radiation Therapy, and Bevacizumab in Treating Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery (NCT NCT00334815)
NCT ID: NCT00334815
Last Updated: 2025-08-24
Results Overview
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Up to one year
Results posted on
2025-08-24
Participant Flow
Participant milestones
| Measure |
Low Risk Patient Stratum
Patients with non-squamous histology, a primary tumor with no cavitation and not within 1 cm of a major blood vessel, and no history of hemoptysis.
Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
cisplatin: Given IV
etoposide: Given IV
radiation therapy: Undergo thoracic radiotherapy
docetaxel: Given IV
filgrastim: Given SC
pegfilgrastim: Given SC
|
High Risk Patient Stratum
Patients with at least one of the following characteristics: squamous histology, a primary tumor with cavitation or within 1 cm of a major blood vessel, a history of hemoptysis.
Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
cisplatin: Given IV
etoposide: Given IV
radiation therapy: Undergo thoracic radiotherapy
docetaxel: Given IV
filgrastim: Given SC
pegfilgrastim: Given SC
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
13
|
|
Overall Study
COMPLETED
|
9
|
3
|
|
Overall Study
NOT COMPLETED
|
7
|
10
|
Reasons for withdrawal
| Measure |
Low Risk Patient Stratum
Patients with non-squamous histology, a primary tumor with no cavitation and not within 1 cm of a major blood vessel, and no history of hemoptysis.
Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
cisplatin: Given IV
etoposide: Given IV
radiation therapy: Undergo thoracic radiotherapy
docetaxel: Given IV
filgrastim: Given SC
pegfilgrastim: Given SC
|
High Risk Patient Stratum
Patients with at least one of the following characteristics: squamous histology, a primary tumor with cavitation or within 1 cm of a major blood vessel, a history of hemoptysis.
Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
cisplatin: Given IV
etoposide: Given IV
radiation therapy: Undergo thoracic radiotherapy
docetaxel: Given IV
filgrastim: Given SC
pegfilgrastim: Given SC
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Progression
|
1
|
0
|
|
Overall Study
ineligible
|
1
|
1
|
|
Overall Study
patient refused treatment
|
0
|
1
|
|
Overall Study
Physician Decision
|
2
|
4
|
Baseline Characteristics
Combination Chemotherapy, Radiation Therapy, and Bevacizumab in Treating Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Low Risk Patient Stratum
n=15 Participants
|
High Risk Patient Stratum
n=11 Participants
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.5 years
n=5 Participants
|
63.4 years
n=7 Participants
|
60.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
11 participants
n=7 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to one yearPopulation: All eligible patients, both low-risk and high-risk strata combined, who received protocol therapy.
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome measures
| Measure |
Concurrent Chemotherapy and Radiotherapy
n=26 Participants
|
Consolidation Therapy With Docetaxel and Bevacizumab.
n=21 Participants
|
|---|---|---|
|
Adverse Events
Hemoglobin
|
2 Participants
|
2 Participants
|
|
Adverse Events
Acidosis (metabolic or respiratory)
|
0 Participants
|
1 Participants
|
|
Adverse Events
Arthritis (non-septic)
|
0 Participants
|
1 Participants
|
|
Adverse Events
Calcium, serum-low (hypocalcemia)
|
0 Participants
|
1 Participants
|
|
Adverse Events
Carbon monoxide diffusion capacity (DL(co))
|
1 Participants
|
0 Participants
|
|
Adverse Events
Creatinine
|
1 Participants
|
0 Participants
|
|
Adverse Events
Dehydration
|
1 Participants
|
0 Participants
|
|
Adverse Events
Dyspnea (shortness of breath)
|
1 Participants
|
1 Participants
|
|
Adverse Events
Esophagitis
|
2 Participants
|
0 Participants
|
|
Adverse Events
FEV(1)
|
1 Participants
|
0 Participants
|
|
Adverse Events
Febrile neutropenia
|
3 Participants
|
0 Participants
|
|
Adverse Events
Glucose, serum-high (hyperglycemia)
|
1 Participants
|
0 Participants
|
|
Adverse Events
Hemorrhage, Respiratory tract NOS
|
0 Participants
|
1 Participants
|
|
Adverse Events
Hemorrhage, GI - Peritoneal cavity
|
0 Participants
|
1 Participants
|
|
Adverse Events
Hemorrhage, pulmonary/upper respiratory - Lung
|
0 Participants
|
1 Participants
|
|
Adverse Events
Hypotension
|
1 Participants
|
0 Participants
|
|
Adverse Events
Hypoxia
|
0 Participants
|
1 Participants
|
|
Adverse Events
INR (of prothrombin time)
|
1 Participants
|
0 Participants
|
|
Adverse Events
Inf (clin/microbio) w/Gr 3-4 neuts - Nose
|
1 Participants
|
0 Participants
|
|
Adverse Events
Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums
|
1 Participants
|
0 Participants
|
|
Adverse Events
Inf (clin/microbio) w/Gr 3-4 neuts - UTI
|
1 Participants
|
0 Participants
|
|
Adverse Events
Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway
|
0 Participants
|
1 Participants
|
|
Adverse Events
Inf w/normal ANC or Gr 1-2 neutrophils - Blood
|
1 Participants
|
0 Participants
|
|
Adverse Events
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
1 Participants
|
0 Participants
|
|
Adverse Events
Leukocytes (total WBC)
|
6 Participants
|
0 Participants
|
|
Adverse Events
Lymphopenia
|
2 Participants
|
3 Participants
|
|
Adverse Events
Muscle weakness, not d/t neuropathy - body/general
|
1 Participants
|
1 Participants
|
|
Adverse Events
Nausea
|
2 Participants
|
0 Participants
|
|
Adverse Events
Neutrophils/granulocytes (ANC/AGC)
|
10 Participants
|
0 Participants
|
|
Adverse Events
Pain - Chest wall
|
1 Participants
|
0 Participants
|
|
Adverse Events
Pain - Chest/thorax NOS
|
1 Participants
|
0 Participants
|
|
Adverse Events
Pain - Head/headache
|
1 Participants
|
0 Participants
|
|
Adverse Events
Pain - Joint
|
0 Participants
|
1 Participants
|
|
Adverse Events
Pain - Neck
|
1 Participants
|
0 Participants
|
|
Adverse Events
Pain - Throat/pharynx/larynx
|
1 Participants
|
0 Participants
|
|
Adverse Events
Platelets
|
2 Participants
|
0 Participants
|
|
Adverse Events
Pneumonitis/pulmonary infiltrates
|
1 Participants
|
2 Participants
|
|
Adverse Events
Potassium, serum-low (hypokalemia)
|
3 Participants
|
1 Participants
|
|
Adverse Events
Pulmonary/Upper Respiratory-Other (Specify)
|
0 Participants
|
1 Participants
|
|
Adverse Events
Rash/desquamation
|
1 Participants
|
0 Participants
|
|
Adverse Events
Rash: dermatitis associated w/radiation
|
1 Participants
|
0 Participants
|
|
Adverse Events
Sodium, serum-low (hyponatremia)
|
1 Participants
|
0 Participants
|
|
Adverse Events
Weight loss
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Disease assessments were performed every 10 weeks as long as the patient remained on protocol treatment, up to 4 years.From date of registration to time of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Outcome measures
| Measure |
Concurrent Chemotherapy and Radiotherapy
n=15 Participants
|
Consolidation Therapy With Docetaxel and Bevacizumab.
n=11 Participants
|
|---|---|---|
|
Progression-free Survival
|
38 Months
Interval 23.0 to 46.0
|
15 Months
Interval 5.0 to 17.0
|
SECONDARY outcome
Timeframe: Every week, up to 4 yearsFrom date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Outcome measures
| Measure |
Concurrent Chemotherapy and Radiotherapy
n=15 Participants
|
Consolidation Therapy With Docetaxel and Bevacizumab.
n=11 Participants
|
|---|---|---|
|
Overall Survival
|
46 Months
Interval 26.0 to 51.0
|
17 Months
Interval 5.0 to 18.0
|
SECONDARY outcome
Timeframe: Response assessment occured at the end of CRT and docetaxel/bevacizumab and then every 2-3 months for 2 years and then every 6 months until 4 years after the initial registrationPopulation: Only patients with measurable disease at baseline were included in the analysis of response. Among 15 patients on the Low Risk stratum, 14 had measureable disease at baseline. Among 11 patients on the High Risk stratum, 10 had measureable disease at baseline.
Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions.
Outcome measures
| Measure |
Concurrent Chemotherapy and Radiotherapy
n=14 Participants
|
Consolidation Therapy With Docetaxel and Bevacizumab.
n=10 Participants
|
|---|---|---|
|
Response Rate (Confirmed or Unconfirmed Partial Response)
|
64 percentage of participants
Interval 35.0 to 87.0
|
70 percentage of participants
Interval 35.0 to 93.0
|
Adverse Events
Concurrent Chemotherapy and Radiotherapy
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Consolidation Therapy With Docetaxel and Bevacizumab
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Concurrent Chemotherapy and Radiotherapy
n=26 participants at risk
All eligible patients, both low-risk and high-risk strata combined, who received concurrent chemotherapy and radiotherapy.
|
Consolidation Therapy With Docetaxel and Bevacizumab
n=21 participants at risk
All eligible patients, both low-risk and high-risk strata combined, who received consolidation therapy with Docetaxel and Bevacizumab.
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/26 • Up to one year.
|
4.8%
1/21 • Up to one year.
|
|
Gastrointestinal disorders
Hemorrhage, GI - Peritoneal cavity
|
0.00%
0/26 • Up to one year.
|
4.8%
1/21 • Up to one year.
|
|
Injury, poisoning and procedural complications
Thrombosis/embolism (vascular access-related)
|
0.00%
0/26 • Up to one year.
|
4.8%
1/21 • Up to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/26 • Up to one year.
|
4.8%
1/21 • Up to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, Respiratory tract NOS
|
0.00%
0/26 • Up to one year.
|
4.8%
1/21 • Up to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Lung
|
0.00%
0/26 • Up to one year.
|
4.8%
1/21 • Up to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/26 • Up to one year.
|
4.8%
1/21 • Up to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.00%
0/26 • Up to one year.
|
4.8%
1/21 • Up to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other
|
0.00%
0/26 • Up to one year.
|
4.8%
1/21 • Up to one year.
|
Other adverse events
| Measure |
Concurrent Chemotherapy and Radiotherapy
n=26 participants at risk
All eligible patients, both low-risk and high-risk strata combined, who received concurrent chemotherapy and radiotherapy.
|
Consolidation Therapy With Docetaxel and Bevacizumab
n=21 participants at risk
All eligible patients, both low-risk and high-risk strata combined, who received consolidation therapy with Docetaxel and Bevacizumab.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.5%
3/26 • Up to one year.
|
0.00%
0/21 • Up to one year.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
34.6%
9/26 • Up to one year.
|
38.1%
8/21 • Up to one year.
|
|
Eye disorders
Vision-blurred vision
|
19.2%
5/26 • Up to one year.
|
0.00%
0/21 • Up to one year.
|
|
Gastrointestinal disorders
Constipation
|
30.8%
8/26 • Up to one year.
|
4.8%
1/21 • Up to one year.
|
|
Gastrointestinal disorders
Diarrhea
|
15.4%
4/26 • Up to one year.
|
14.3%
3/21 • Up to one year.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
38.5%
10/26 • Up to one year.
|
4.8%
1/21 • Up to one year.
|
|
Gastrointestinal disorders
Esophagitis
|
46.2%
12/26 • Up to one year.
|
9.5%
2/21 • Up to one year.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
26.9%
7/26 • Up to one year.
|
4.8%
1/21 • Up to one year.
|
|
Gastrointestinal disorders
Nausea
|
65.4%
17/26 • Up to one year.
|
19.0%
4/21 • Up to one year.
|
|
Gastrointestinal disorders
Pain - Esophagus
|
7.7%
2/26 • Up to one year.
|
0.00%
0/21 • Up to one year.
|
|
Gastrointestinal disorders
Vomiting
|
34.6%
9/26 • Up to one year.
|
14.3%
3/21 • Up to one year.
|
|
General disorders
Edema: limb
|
7.7%
2/26 • Up to one year.
|
0.00%
0/21 • Up to one year.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
80.8%
21/26 • Up to one year.
|
47.6%
10/21 • Up to one year.
|
|
General disorders
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
11.5%
3/26 • Up to one year.
|
0.00%
0/21 • Up to one year.
|
|
General disorders
Pain - Chest/thorax NOS
|
15.4%
4/26 • Up to one year.
|
19.0%
4/21 • Up to one year.
|
|
General disorders
Rigors/chills
|
11.5%
3/26 • Up to one year.
|
4.8%
1/21 • Up to one year.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
7.7%
2/26 • Up to one year.
|
0.00%
0/21 • Up to one year.
|
|
Injury, poisoning and procedural complications
Rash: dermatitis associated w/Chemoradiation
|
7.7%
2/26 • Up to one year.
|
9.5%
2/21 • Up to one year.
|
|
Injury, poisoning and procedural complications
Rash: dermatitis associated w/radiation
|
15.4%
4/26 • Up to one year.
|
0.00%
0/21 • Up to one year.
|
|
Investigations
Creatinine
|
7.7%
2/26 • Up to one year.
|
0.00%
0/21 • Up to one year.
|
|
Investigations
Leukocytes (total WBC)
|
34.6%
9/26 • Up to one year.
|
9.5%
2/21 • Up to one year.
|
|
Investigations
Lymphopenia
|
23.1%
6/26 • Up to one year.
|
14.3%
3/21 • Up to one year.
|
|
Investigations
Metabolic/Laboratory-Other
|
0.00%
0/26 • Up to one year.
|
9.5%
2/21 • Up to one year.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
53.8%
14/26 • Up to one year.
|
0.00%
0/21 • Up to one year.
|
|
Investigations
Platelets
|
38.5%
10/26 • Up to one year.
|
23.8%
5/21 • Up to one year.
|
|
Investigations
Weight loss
|
23.1%
6/26 • Up to one year.
|
14.3%
3/21 • Up to one year.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
19.2%
5/26 • Up to one year.
|
14.3%
3/21 • Up to one year.
|
|
Metabolism and nutrition disorders
Anorexia
|
30.8%
8/26 • Up to one year.
|
14.3%
3/21 • Up to one year.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
19.2%
5/26 • Up to one year.
|
14.3%
3/21 • Up to one year.
|
|
Metabolism and nutrition disorders
Dehydration
|
15.4%
4/26 • Up to one year.
|
0.00%
0/21 • Up to one year.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
30.8%
8/26 • Up to one year.
|
28.6%
6/21 • Up to one year.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
7.7%
2/26 • Up to one year.
|
4.8%
1/21 • Up to one year.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
7.7%
2/26 • Up to one year.
|
0.00%
0/21 • Up to one year.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
19.2%
5/26 • Up to one year.
|
14.3%
3/21 • Up to one year.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
19.2%
5/26 • Up to one year.
|
0.00%
0/21 • Up to one year.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
15.4%
4/26 • Up to one year.
|
14.3%
3/21 • Up to one year.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue-Other
|
3.8%
1/26 • Up to one year.
|
9.5%
2/21 • Up to one year.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
3.8%
1/26 • Up to one year.
|
19.0%
4/21 • Up to one year.
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
0.00%
0/26 • Up to one year.
|
19.0%
4/21 • Up to one year.
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
3.8%
1/26 • Up to one year.
|
9.5%
2/21 • Up to one year.
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
3.8%
1/26 • Up to one year.
|
9.5%
2/21 • Up to one year.
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
0.00%
0/26 • Up to one year.
|
19.0%
4/21 • Up to one year.
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
7.7%
2/26 • Up to one year.
|
14.3%
3/21 • Up to one year.
|
|
Musculoskeletal and connective tissue disorders
Pain - Neck
|
3.8%
1/26 • Up to one year.
|
9.5%
2/21 • Up to one year.
|
|
Nervous system disorders
Dizziness
|
11.5%
3/26 • Up to one year.
|
4.8%
1/21 • Up to one year.
|
|
Nervous system disorders
Neuropathy: sensory
|
7.7%
2/26 • Up to one year.
|
23.8%
5/21 • Up to one year.
|
|
Nervous system disorders
Pain - Head/headache
|
19.2%
5/26 • Up to one year.
|
4.8%
1/21 • Up to one year.
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
11.5%
3/26 • Up to one year.
|
4.8%
1/21 • Up to one year.
|
|
Psychiatric disorders
Confusion
|
7.7%
2/26 • Up to one year.
|
0.00%
0/21 • Up to one year.
|
|
Renal and urinary disorders
Renal/Genitourinary-Other
|
7.7%
2/26 • Up to one year.
|
0.00%
0/21 • Up to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
34.6%
9/26 • Up to one year.
|
42.9%
9/21 • Up to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
23.1%
6/26 • Up to one year.
|
23.8%
5/21 • Up to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Lung
|
7.7%
2/26 • Up to one year.
|
4.8%
1/21 • Up to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
19.2%
5/26 • Up to one year.
|
0.00%
0/21 • Up to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
11.5%
3/26 • Up to one year.
|
4.8%
1/21 • Up to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Throat/pharynx/larynx
|
23.1%
6/26 • Up to one year.
|
4.8%
1/21 • Up to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
3.8%
1/26 • Up to one year.
|
23.8%
5/21 • Up to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
11.5%
3/26 • Up to one year.
|
19.0%
4/21 • Up to one year.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.7%
2/26 • Up to one year.
|
0.00%
0/21 • Up to one year.
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
42.3%
11/26 • Up to one year.
|
19.0%
4/21 • Up to one year.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
11.5%
3/26 • Up to one year.
|
0.00%
0/21 • Up to one year.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
7.7%
2/26 • Up to one year.
|
0.00%
0/21 • Up to one year.
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
7.7%
2/26 • Up to one year.
|
9.5%
2/21 • Up to one year.
|
|
Vascular disorders
Hypotension
|
11.5%
3/26 • Up to one year.
|
0.00%
0/21 • Up to one year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60