Trial Outcomes & Findings for Dasatinib in Treating Patients With Relapsed Small Cell Lung Cancer (NCT NCT00470054)
NCT ID: NCT00470054
Last Updated: 2015-05-05
Results Overview
Percentage of patients who were alive and progression free at 6-weeks. The 6-week progression free survival was estimated using the Kaplan Meier method. Progressive Disease was defined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria as 20% increase in sum of longest diameter of target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
6 weeks
Results posted on
2015-05-05
Participant Flow
Between July 2007 and December 2008, 45 participants were recruited.
One(1) participant cancelled before receiving any protocol related therapy and 1 participant was deemed ineligible. All participants receiving treatment were analyzed for adverse events and only eligible (43) participants were analyzed for al other endpoints.
Participant milestones
| Measure |
Dasatinib
Pts receive oral dasatinib 70 mg twice daily
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Dasatinib
Pts receive oral dasatinib 70 mg twice daily
|
|---|---|
|
Overall Study
Ineligible
|
1
|
Baseline Characteristics
Dasatinib in Treating Patients With Relapsed Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Dasatinib
n=43 Participants
Pts receive oral dasatinib 70 mg twice daily
|
|---|---|
|
Age, Continuous
|
64 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=99 Participants
|
|
ECOG Performance Status
0 - Fully Active
|
12 participants
n=99 Participants
|
|
ECOG Performance Status
1 - Ambulatory, restricted strenuous activity
|
31 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: All eligible participants were analyzed.
Percentage of patients who were alive and progression free at 6-weeks. The 6-week progression free survival was estimated using the Kaplan Meier method. Progressive Disease was defined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria as 20% increase in sum of longest diameter of target lesions.
Outcome measures
| Measure |
Dasatinib
n=43 Participants
Pts receive oral dasatinib 70 mg twice daily
|
|---|---|
|
6 Week Progression Free Survival
|
43 percentage of participants
Interval 30.0 to 61.0
|
SECONDARY outcome
Timeframe: Time from registration to progression (up to 3 years)Population: All eligible participants were analyzed.
PFS was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure.
Outcome measures
| Measure |
Dasatinib
n=43 Participants
Pts receive oral dasatinib 70 mg twice daily
|
|---|---|
|
Progression Free Survival (PFS)
|
5.9 weeks
Interval 5.7 to 6.6
|
SECONDARY outcome
Timeframe: Assessed every 2 cycles (up to 3 years)Population: All eligible participants were analyzed.
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: * Complete Response (CR): disappearance of all target lesions; * Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; * Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; * Stable Disease (SD): small changes that do not meet above criteria.
Outcome measures
| Measure |
Dasatinib
n=43 Participants
Pts receive oral dasatinib 70 mg twice daily
|
|---|---|
|
Response to Therapy
Complete Response
|
0 participants
|
|
Response to Therapy
Partial Response
|
0 participants
|
|
Response to Therapy
Stable Disease
|
7 participants
|
|
Response to Therapy
Progression
|
28 participants
|
|
Response to Therapy
Inadequately assessed
|
8 participants
|
SECONDARY outcome
Timeframe: Time from registration to death (up to 3 years)Population: All eligible participants were analyzed.
Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Dasatinib
n=43 Participants
Pts receive oral dasatinib 70 mg twice daily
|
|---|---|
|
Overall Survival
|
17 weeks
Interval 14.6 to 29.7
|
SECONDARY outcome
Timeframe: Assessed during treatmentPopulation: All 44 participants who received treatment were analyzed (including ineligible participants).
The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 was used to evaluate toxicity. Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death.
Outcome measures
| Measure |
Dasatinib
n=44 Participants
Pts receive oral dasatinib 70 mg twice daily
|
|---|---|
|
Number of Participants With Grade 3 or Higher Adverse Events
|
12 participants
|
Adverse Events
Dasatinib
Serious events: 14 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dasatinib
n=44 participants at risk
Pts receive oral dasatinib 70 mg twice daily
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
27.3%
12/44 • Number of events 16
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Blood and lymphatic system disorders
Lymph node pain
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Cardiac disorders
Pericardial effusion
|
6.8%
3/44 • Number of events 3
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Gastrointestinal disorders
Constipation
|
4.5%
2/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Gastrointestinal disorders
Diarrhea
|
13.6%
6/44 • Number of events 6
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Gastrointestinal disorders
Dry mouth
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Gastrointestinal disorders
Nausea
|
9.1%
4/44 • Number of events 4
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Gastrointestinal disorders
Pain
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
3/44 • Number of events 3
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
General disorders
Death not associated with CTCAE term
|
4.5%
2/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
General disorders
Edema: limb
|
9.1%
4/44 • Number of events 4
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
General disorders
Fatigue
|
27.3%
12/44 • Number of events 15
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
General disorders
Fever
|
9.1%
4/44 • Number of events 4
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Investigations
Alanine aminotransferase increased
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Investigations
Alkaline phosphatase
|
4.5%
2/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Investigations
Aspartate aminotransferase increased
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Investigations
Blood bilirubin increased
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Investigations
Cholesterol serum-high (hypercholesteremia)
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Investigations
Creatinine
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Investigations
Leukocytes (total WBC)
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Investigations
Lymphopenia
|
4.5%
2/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
2.3%
1/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Investigations
Platelet count decreased
|
11.4%
5/44 • Number of events 7
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Investigations
Prolonged QTc interval
|
4.5%
2/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
4.5%
2/44 • Number of events 3
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Metabolism and nutrition disorders
Anorexia
|
9.1%
4/44 • Number of events 4
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Metabolism and nutrition disorders
Calcium serum-low (hypocalcemia)
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Metabolism and nutrition disorders
Dehydration
|
6.8%
3/44 • Number of events 3
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Metabolism and nutrition disorders
Glucose serum-high (hyperglycemia)
|
9.1%
4/44 • Number of events 4
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Metabolism and nutrition disorders
Magnesium serum-high (hypermagnesemia)
|
4.5%
2/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Metabolism and nutrition disorders
Magnesium serum-low (hypomagnesemia)
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Metabolism and nutrition disorders
Phosphate serum-low (hypophosphatemia)
|
4.5%
2/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Metabolism and nutrition disorders
Potassium serum-high (hyperkalemia)
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Metabolism and nutrition disorders
Potassium serum-low (hypokalemia)
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Metabolism and nutrition disorders
Sodium serum-low (hyponatremia)
|
11.4%
5/44 • Number of events 5
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Nervous system disorders
Headache
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.3%
1/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Psychiatric disorders
Anxiety
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Psychiatric disorders
Confusion
|
2.3%
1/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Psychiatric disorders
Depression
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
4/44 • Number of events 4
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
18.2%
8/44 • Number of events 8
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.5%
2/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
13.6%
6/44 • Number of events 8
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
4.5%
2/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.8%
3/44 • Number of events 3
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
4.5%
2/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Vascular disorders
Flushing
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Vascular disorders
Hypotension
|
4.5%
2/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
Other adverse events
| Measure |
Dasatinib
n=44 participants at risk
Pts receive oral dasatinib 70 mg twice daily
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
54.5%
24/44 • Number of events 45
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Blood and lymphatic system disorders
Lymphatics - Other
|
2.3%
1/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Cardiac disorders
Sinus tachycardia
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Eye disorders
Cataract
|
2.3%
1/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Eye disorders
Ocular/Visual - Other
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Gastrointestinal disorders
Abdominal distension
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Gastrointestinal disorders
Constipation
|
13.6%
6/44 • Number of events 8
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
11/44 • Number of events 13
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Gastrointestinal disorders
Dyspepsia
|
4.5%
2/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Gastrointestinal disorders
Dysphagia
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Gastrointestinal disorders
Nausea
|
11.4%
5/44 • Number of events 7
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Gastrointestinal disorders
Pain
|
4.5%
2/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
8/44 • Number of events 8
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
General disorders
Death NOS
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
General disorders
Death not associated with CTCAE term
|
11.4%
5/44 • Number of events 8
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
General disorders
Edema: limb
|
9.1%
4/44 • Number of events 5
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
General disorders
Edema:head and neck
|
6.8%
3/44 • Number of events 4
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
General disorders
Fatigue
|
77.3%
34/44 • Number of events 62
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
General disorders
Fever
|
4.5%
2/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
General disorders
Syndromes - Other
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Investigations
Alanine aminotransferase increased
|
9.1%
4/44 • Number of events 4
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Investigations
Alkaline phosphatase
|
9.1%
4/44 • Number of events 5
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Investigations
Aspartate aminotransferase increased
|
11.4%
5/44 • Number of events 6
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Investigations
Blood bilirubin increased
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Investigations
Creatinine
|
2.3%
1/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Investigations
INR (International Normalized Ratio of prothrombin time)
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Investigations
Lymphopenia
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
9.1%
4/44 • Number of events 6
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Investigations
Platelet count decreased
|
13.6%
6/44 • Number of events 13
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Investigations
Prolonged QTc interval
|
2.3%
1/44 • Number of events 3
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Investigations
Weight loss
|
4.5%
2/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
6.8%
3/44 • Number of events 4
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Metabolism and nutrition disorders
Anorexia
|
15.9%
7/44 • Number of events 8
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Metabolism and nutrition disorders
Calcium serum-high (hypercalcemia)
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Metabolism and nutrition disorders
Glucose serum-high (hyperglycemia)
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Metabolism and nutrition disorders
Potassium serum-low (hypokalemia)
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Metabolism and nutrition disorders
Sodium serum-low (hyponatremia)
|
4.5%
2/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.3%
1/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
4.5%
2/44 • Number of events 3
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.5%
2/44 • Number of events 3
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Nervous system disorders
Dysgeusia
|
2.3%
1/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Nervous system disorders
Headache
|
6.8%
3/44 • Number of events 4
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
11/44 • Number of events 15
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Psychiatric disorders
Insomnia
|
4.5%
2/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Reproductive system and breast disorders
Breast pain
|
2.3%
1/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.9%
7/44 • Number of events 7
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.5%
2/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
20.5%
9/44 • Number of events 11
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.8%
3/44 • Number of events 3
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.3%
1/44 • Number of events 1
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
4.5%
2/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.5%
2/44 • Number of events 2
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.5%
2/44 • Number of events 3
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.4%
5/44 • Number of events 7
All 44 participants who received treatment were analyzed (including ineligible participants).
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
27.3%
12/44 • Number of events 19
All 44 participants who received treatment were analyzed (including ineligible participants).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60