Trial Outcomes & Findings for Study of Cetuximab With Radiation Followed by Consolidation Chemotherapy for NSCLC (NCT NCT00492206)
NCT ID: NCT00492206
Last Updated: 2017-02-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Up to 36 months
Results posted on
2017-02-01
Participant Flow
Subjects recruited from the surgically unresectable stage IIIA or IIIB NSCLC patient populations
Non-Small Cell Lung Cancer, unresectable limited to Stage IIIA/B.
Participant milestones
| Measure |
Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca
Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m\^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Cetuximab With Radiation Followed by Consolidation Chemotherapy for NSCLC
Baseline characteristics by cohort
| Measure |
Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca
n=40 Participants
Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m\^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
|
|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
|
Gender
Female
|
14 Participants
n=5 Participants
|
|
Gender
Male
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 36 monthsPopulation: Patients with surgically unresectable stage IIIA or IIIB NSCLC. Survival analysis excluded the two ineligible patients with advanced NSCLC (N = 38).
Outcome measures
| Measure |
Received ≥1 Dose of Cetuximab
n=38 Participants
Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m\^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
|
|---|---|
|
Overall Survival (OS)
|
19.4 months
Interval 15.4 to 26.0
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Patients with surgically unresectable stage IIIA or IIIB NSCLC. Survival analysis excluded the two ineligible patients with advanced NSCLC.
Response and progression were evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\]. Progressive Disease was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Received ≥1 Dose of Cetuximab
n=38 Participants
Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m\^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
|
|---|---|
|
Progression-free Survival (PFS)
|
9.3 months
Interval 8.5 to 17.2
|
SECONDARY outcome
Timeframe: Up to 12 weeks after treatment initiationPopulation: Patients who received concurrent radiotherapy + cetuximab + consolidation therapy, and patients who did not receive cetuximab
The Best Overall Response is the best response (Complete Response, Partial Response, Stable Disease, Progressive Disease) recorded from the start of the study treatment until the disease progression/recurrence at end of study. Response and progression were evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\]. Complete Response (CR) is the Disappearance of all target lesions and Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Outcome measures
| Measure |
Received ≥1 Dose of Cetuximab
n=40 Participants
Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m\^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
|
|---|---|
|
Best Overall Response Rate (ORR) (Number of Participants)
Complete Response (CR) Rate
|
4 participants
|
|
Best Overall Response Rate (ORR) (Number of Participants)
Partial Response (PR) Rate
|
18 participants
|
|
Best Overall Response Rate (ORR) (Number of Participants)
Stable Disease
|
4 participants
|
|
Best Overall Response Rate (ORR) (Number of Participants)
Progressive Disease
|
6 participants
|
|
Best Overall Response Rate (ORR) (Number of Participants)
Not evaluable
|
8 participants
|
SECONDARY outcome
Timeframe: approx. 5 yearsPopulation: Participants with baseline tumor tissue available for EGFR status analysis by fluorescence in situ hybridization (FISH). Akt, pAkt, and MAPKinase analyses were not conducted.
EGFR (epidermal growth factor receptor) gene mutation status and Akt, pAkt, and MAPKinase in participant tumor tissue.
Outcome measures
| Measure |
Received ≥1 Dose of Cetuximab
n=26 baseline tumor tissue
Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m\^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
|
|---|---|
|
EGFR (Epidermal Growth Factor Receptor) Gene Mutation and Akt, pAkt, and MAPKinase
|
65 percentage of tumors
|
Adverse Events
Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca
Serious events: 11 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca
n=40 participants at risk
Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m\^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
|
|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
2.5%
1/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
General disorders
Constitutional Symptoms - Other (Specify, __)
|
2.5%
1/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
17.5%
7/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Cardiac disorders
Hypotension
|
5.0%
2/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.0%
2/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
10.0%
4/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy), Extraocular
|
2.5%
1/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Nervous system disorders
Neuropathy: sensory
|
2.5%
1/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
20.0%
8/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
General disorders
Pain, Abdomen NOS
|
5.0%
2/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
General disorders
Rigors/chills
|
2.5%
1/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia, Atrial fibrillation
|
5.0%
2/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
Other adverse events
| Measure |
Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca
n=40 participants at risk
Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m\^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
|
|---|---|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
7.5%
3/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
10.0%
4/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Blood and lymphatic system disorders
Hemoglobin
|
10.0%
4/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
20.0%
8/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
50.0%
20/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
60.0%
24/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia, Atrial fibrillation
|
7.5%
3/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia, Sinus tachycardia
|
7.5%
3/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Cardiac disorders
Hypotension
|
10.0%
4/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
General disorders
Constitutional Symptoms - Other (Specify, __)
|
10.0%
4/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
General disorders
Sweating (diaphoresis)
|
10.0%
4/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
General disorders
Rigors/chills
|
15.0%
6/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
20.0%
8/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
General disorders
Insomnia
|
20.0%
8/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
General disorders
Weight loss
|
27.5%
11/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
72.5%
29/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __)
|
7.5%
3/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
10.0%
4/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
10.0%
4/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation, Chemoradiation
|
10.0%
4/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
12.5%
5/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
12.5%
5/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
20.0%
8/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation, Radiation
|
20.0%
8/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
27.5%
11/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
35.0%
14/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
77.5%
31/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Gastrointestinal disorders
Hemorrhoids
|
7.5%
3/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __)
|
15.0%
6/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
15.0%
6/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
17.5%
7/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
10/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Gastrointestinal disorders
Esophagitis
|
27.5%
11/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam), Oral cavity
|
27.5%
11/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Gastrointestinal disorders
Vomiting
|
30.0%
12/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Gastrointestinal disorders
Constipation
|
35.0%
14/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
40.0%
16/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Gastrointestinal disorders
Anorexia
|
52.5%
21/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Gastrointestinal disorders
Nausea
|
57.5%
23/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding - Other (Specify, __)
|
10.0%
4/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia)
|
7.5%
3/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Infections and infestations
Infection - Other (Specify, __)
|
10.0%
4/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Upper airway NOS
|
12.5%
5/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
7.5%
3/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
7.5%
3/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
10.0%
4/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
10.0%
4/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
15.0%
6/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
25.0%
10/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, __)
|
15.0%
6/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Nervous system disorders
Mood alteration, Depression
|
7.5%
3/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Nervous system disorders
Neurology - Other (Specify, __)
|
7.5%
3/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Nervous system disorders
Neuropathy: motor
|
7.5%
3/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Nervous system disorders
Dizziness
|
10.0%
4/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Nervous system disorders
Mood alteration, Anxiety
|
10.0%
4/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Nervous system disorders
Syncope (fainting)
|
15.0%
6/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Nervous system disorders
Neuropathy: sensory
|
32.5%
13/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Eye disorders
Dry eye syndrome
|
7.5%
3/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
7.5%
3/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
General disorders
Pain - Other (Specify, __)
|
7.5%
3/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
General disorders
Pain, Abdomen NOS
|
7.5%
3/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
General disorders
Pain, Throat/pharynx/larynx
|
7.5%
3/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
General disorders
Pain, Chest/thorax NOS
|
10.0%
4/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
General disorders
Pain, Muscle
|
10.0%
4/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
General disorders
Pain, Bone
|
12.5%
5/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
General disorders
Pain, Extremity-limb
|
12.5%
5/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
General disorders
Pain, Joint
|
12.5%
5/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
General disorders
Pain, Back
|
15.0%
6/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
General disorders
Pain, Head/headache
|
30.0%
12/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.5%
3/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
7.5%
3/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __)
|
15.0%
6/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
17.5%
7/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
62.5%
25/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
77.5%
31/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
10.0%
4/40
Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
|
Additional Information
Ahmad Tarhini, MD
University of Pittsburgh Cancer Institute
Phone: 412-648-6507
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60