Trial Outcomes & Findings for Trial of Dasatinib in Patients With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation (NCT NCT01514864)
NCT ID: NCT01514864
Last Updated: 2023-12-19
Results Overview
ORR is defined as the percentage of patients with best tumor response of either Partial Response (a 30% or greater decrease in the sum of the longest diameter \[LD\] of all lesions in reference to the baseline sum LD) or Complete Response (disappearance of clinical and radiologic evidence of target lesions), according to Response Evaluation Criteria in Solid Tumors.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
From enrollment of last patient to 24 months or until all patients have died, whichever occurs first
Results posted on
2023-12-19
Participant Flow
A total of 19 patients were enrolled, and 14 received treatment in 2 cohorts: 9 with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation and 5 with NSCLC and a discoidin domain receptor 2 (DDR2) mutation.
Participant milestones
| Measure |
Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)
Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
|
Dasatinib, 140 mg (NSCLC With DDR2 Mutation)
Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
5
|
Reasons for withdrawal
| Measure |
Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)
Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
|
Dasatinib, 140 mg (NSCLC With DDR2 Mutation)
Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
|
|---|---|---|
|
Overall Study
Disease progression
|
7
|
5
|
|
Overall Study
Study drug toxicity
|
2
|
0
|
Baseline Characteristics
Trial of Dasatinib in Patients With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation
Baseline characteristics by cohort
| Measure |
Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)
n=9 Participants
Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
|
Dasatinib, 140 mg (NSCLC With DDR2 Mutation)
n=5 Participants
Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
67.0 Years
n=5 Participants
|
63.0 Years
n=7 Participants
|
66.5 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 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
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic/Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Time from cancer diagnosis to start of study therapy
|
14.4 Months
n=5 Participants
|
8.5 Months
n=7 Participants
|
12.1 Months
n=5 Participants
|
|
Tumor Type
Nonsmall-cell lung carcinoma
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Tumor Type
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Nonsmall-cell lung carcinoma histology
Adenocarcinoma
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Nonsmall-cell lung carcinoma histology
Bronco-alveolar carcinoma
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Nonsmall-cell lung carcinoma histology
Large cell carcinoma
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Nonsmall-cell lung carcinoma histology
Squamous cell carcinoma
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Histopathologic Grade
G2-moderately differentiated
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Histopathologic Grade
G3-poorly differentiated
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Histopathologic Grade
GX-grade cannot be assessed
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG score 0
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG score 1
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG score 2
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Number of Index Lesions
1
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Number of Index Lesions
2
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Number of Index Lesions
3
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Number of Index Lesions
4
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From enrollment of last patient to 24 months or until all patients have died, whichever occurs firstPopulation: All participants who received at least 1 dose of study drug. Because no patients had a response of CR or PR, ORR could not be calculated.
ORR is defined as the percentage of patients with best tumor response of either Partial Response (a 30% or greater decrease in the sum of the longest diameter \[LD\] of all lesions in reference to the baseline sum LD) or Complete Response (disappearance of clinical and radiologic evidence of target lesions), according to Response Evaluation Criteria in Solid Tumors.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment of last patient to 24 months or until all patients have died, whichever occurs firstPopulation: All participants who received at least 1 dose of study drug. Because no patients had a response of CR or PR, DOR could not be calculated.
DOR is defined as the time from the first assessment documentation of partial response (PR) or complete response (CR) until the first assessment documentation of disease progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment of last patient to 24 months or until all patients have died, whichever occurs firstPopulation: All participants who received treatment
Overall survival is defined as the time from treatment start date to the date of death. If a patient does not die, survival will be censored on the last date the patient was known to be alive.
Outcome measures
| Measure |
Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)
n=9 Participants
Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
|
Dasatinib, 140 mg (NSCLC With DDR2 Mutation)
n=5 Participants
Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
|
|---|---|---|
|
Overall Survival
|
3.06 Months
Interval 0.76 to 6.47
|
4.21 Months
Interval 0.82 to
The upper limit Confidence Interval cannot be estimated
|
SECONDARY outcome
Timeframe: From Day 1 of study treatment to Week 12Population: All participants who received at least 1 dose of study drug
PFS distribution is defined as the percentage of patients with no documentation of disease progression at a specified time point. Confidence interval computed using the Brookmeyer and Crowley method
Outcome measures
| Measure |
Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)
n=9 Participants
Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
|
Dasatinib, 140 mg (NSCLC With DDR2 Mutation)
n=5 Participants
Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
|
|---|---|---|
|
Progression-free Survival (PFS) Distribution
|
1.41 Percentage of participants
Interval 0.72 to 1.87
|
1.38 Percentage of participants
Interval 0.59 to 2.96
|
SECONDARY outcome
Timeframe: From Day 1 of study treatment to Week 12Population: All participants who received at least 1 dose of study drug
PFS is defined as the time from treatment start date to the earliest evidence of disease progression or death. Patients who die or whose disease does not progress will be censored on the date of their last tumor assessment.
Outcome measures
| Measure |
Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)
n=9 Participants
Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
|
Dasatinib, 140 mg (NSCLC With DDR2 Mutation)
n=5 Participants
Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
|
|---|---|---|
|
Progression-free Survival (PFS)
|
1.41 Months
Interval 0.72 to 1.87
|
1.38 Months
Interval 0.59 to 2.96
|
SECONDARY outcome
Timeframe: From enrollment of last patient to 24 months or until all patients have died, whichever occurs firstPopulation: All participants who received at least 1 dose of study drug
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or unknown relationship to study drug.
Outcome measures
| Measure |
Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)
n=9 Participants
Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
|
Dasatinib, 140 mg (NSCLC With DDR2 Mutation)
n=5 Participants
Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
|
|---|---|---|
|
Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation
SAEs
|
7 Participants
|
4 Participants
|
|
Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation
Death
|
8 Participants
|
4 Participants
|
|
Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation
Death within 30 days of last treatment
|
3 Participants
|
1 Participants
|
|
Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation
Drug-related SAEs
|
0 Participants
|
1 Participants
|
|
Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation
AEs leading to discontinuation
|
7 Participants
|
2 Participants
|
|
Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation
Drug-related AEs leading to discontinuation
|
2 Participants
|
0 Participants
|
|
Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation
Drug-related AEs
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From enrollment of last patient to 24 months or until all patients have died, whichever occurs firstPopulation: All participants who received study drug.
Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to adverse event. Laboratory values graded by Common Terminology Criteria for Adverse Events, volume 3. Hemoglobin, Grade 3: \<8.0 - 6.5 g/dL, \<4.9-4.0 mmol/L, \<80-65 g/L. Alkaline phosphatase, Grade 3: \>5.0-20.0\*upper limit of normal (ULN). Total bilirubin, Grade 3: \>3.0-10.0\*ULN. Calcium, low, Grade 3: \<7.0-6.0 mg/dL, \<1.75-1.5 mmol/L.
Outcome measures
| Measure |
Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)
n=14 Participants
Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
|
Dasatinib, 140 mg (NSCLC With DDR2 Mutation)
Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
|
|---|---|---|
|
Number of Participants With Laboratory Testing Results That Meet the Criteria for Grade 3 or 4 Abnormality
Hemoglobin, Grade 3
|
2 Participants
|
—
|
|
Number of Participants With Laboratory Testing Results That Meet the Criteria for Grade 3 or 4 Abnormality
Alkaline phosphatase, Grade 3
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Testing Results That Meet the Criteria for Grade 3 or 4 Abnormality
Total bilirubin, Grade 3
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Testing Results That Meet the Criteria for Grade 3 or 4 Abnormality
Calcium, low, Grade 3
|
1 Participants
|
—
|
Adverse Events
Dasatinib, 140 mg
Serious events: 11 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dasatinib, 140 mg
n=14 participants at risk
Participants with nonsmall-cell lung cancer received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred. Data from both arms were combined for safety reporting, because the safety profile of dasatinib should not have be affected by the type of mutation in the tumor. In addition, pooling the data from both arms increased the robustness of the data set.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
7.1%
1/14
|
|
Gastrointestinal disorders
Diverticular perforation
|
7.1%
1/14
|
|
Infections and infestations
Lung infection
|
14.3%
2/14
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
14.3%
2/14
|
|
Hepatobiliary disorders
Cholangitis
|
7.1%
1/14
|
|
Infections and infestations
Lower respiratory tract infection
|
7.1%
1/14
|
|
Cardiac disorders
Angina pectoris
|
7.1%
1/14
|
|
Cardiac disorders
Atrial fibrillation
|
7.1%
1/14
|
|
General disorders
General physical health deterioration
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
7.1%
1/14
|
|
Cardiac disorders
Angina unstable
|
7.1%
1/14
|
|
Investigations
Haemoglobin decreased
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
7.1%
1/14
|
|
Investigations
Lipase increased
|
7.1%
1/14
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
7.1%
1/14
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
7.1%
1/14
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
28.6%
4/14
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.1%
1/14
|
|
General disorders
Pain
|
7.1%
1/14
|
|
Psychiatric disorders
Panic reaction
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
2/14
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
7.1%
1/14
|
Other adverse events
| Measure |
Dasatinib, 140 mg
n=14 participants at risk
Participants with nonsmall-cell lung cancer received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred. Data from both arms were combined for safety reporting, because the safety profile of dasatinib should not have be affected by the type of mutation in the tumor. In addition, pooling the data from both arms increased the robustness of the data set.
|
|---|---|
|
Investigations
Blood alkaline phosphatase increased
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.1%
1/14
|
|
Hepatobiliary disorders
Hepatic pain
|
7.1%
1/14
|
|
General disorders
Pyrexia
|
14.3%
2/14
|
|
Nervous system disorders
Sedation
|
7.1%
1/14
|
|
Eye disorders
Uveitis
|
7.1%
1/14
|
|
Investigations
Calcium ionised increased
|
7.1%
1/14
|
|
Gastrointestinal disorders
Diverticular perforation
|
7.1%
1/14
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14
|
|
Nervous system disorders
Dysgeusia
|
7.1%
1/14
|
|
Eye disorders
Eyelid oedema
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
14.3%
2/14
|
|
Gastrointestinal disorders
Pancreatitis
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
28.6%
4/14
|
|
Eye disorders
Vision blurred
|
7.1%
1/14
|
|
Investigations
Blood alkaline phosphatase
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Decreased appetite
|
21.4%
3/14
|
|
Vascular disorders
Deep vein thrombosis
|
7.1%
1/14
|
|
General disorders
Fatigue
|
50.0%
7/14
|
|
Nervous system disorders
Headache
|
21.4%
3/14
|
|
Infections and infestations
Lower respiratory tract infection
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
7.1%
1/14
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
2/14
|
|
Cardiac disorders
Angina pectoris
|
7.1%
1/14
|
|
Psychiatric disorders
Anxiety
|
14.3%
2/14
|
|
General disorders
Asthenia
|
7.1%
1/14
|
|
Investigations
Blood glucose increased
|
7.1%
1/14
|
|
Psychiatric disorders
Confusional state
|
14.3%
2/14
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
7.1%
1/14
|
|
Gastrointestinal disorders
Nausea
|
35.7%
5/14
|
|
General disorders
Oedema peripheral
|
21.4%
3/14
|
|
Nervous system disorders
Parosmia
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.1%
1/14
|
|
Vascular disorders
Vasculitis
|
7.1%
1/14
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.1%
1/14
|
|
Investigations
Blood albumin decreased
|
7.1%
1/14
|
|
Investigations
Haemoglobin decreased
|
14.3%
2/14
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
7.1%
1/14
|
|
General disorders
Oedema
|
14.3%
2/14
|
|
Infections and infestations
Pneumonia
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
1/14
|
|
Infections and infestations
Viral infection
|
7.1%
1/14
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
4/14
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
7.1%
1/14
|
|
General disorders
Extravasation
|
7.1%
1/14
|
|
Ear and labyrinth disorders
Hearing impaired
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.1%
1/14
|
|
Investigations
Lipase increased
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
7.1%
1/14
|
|
Renal and urinary disorders
Nocturia
|
7.1%
1/14
|
|
Gastrointestinal disorders
Stomatitis
|
7.1%
1/14
|
|
Nervous system disorders
Tremor
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.1%
1/14
|
|
General disorders
Chest pain
|
14.3%
2/14
|
|
Investigations
Electrocardiogram ST segment elevation
|
7.1%
1/14
|
|
Eye disorders
Eye disorder
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.1%
1/14
|
|
General disorders
Pain
|
14.3%
2/14
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
7.1%
1/14
|
|
Renal and urinary disorders
Urinary straining
|
7.1%
1/14
|
|
General disorders
Chills
|
7.1%
1/14
|
|
Gastrointestinal disorders
Diarrhoea
|
21.4%
3/14
|
|
Gastrointestinal disorders
Dysphagia
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
42.9%
6/14
|
|
Psychiatric disorders
Insomnia
|
7.1%
1/14
|
|
Nervous system disorders
Neuropathy peripheral
|
14.3%
2/14
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.1%
1/14
|
|
Investigations
Weight decreased
|
7.1%
1/14
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER