Trial Outcomes & Findings for E7389 in Treating Patients With Recurrent or Progressive Stage IIIB or Stage IV Non-Small Cell Lung Cancer (NCT NCT00400829)
NCT ID: NCT00400829
Last Updated: 2015-01-07
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
Tumor measurements repeated every 6 weeks
Results posted on
2015-01-07
Participant Flow
Participant milestones
| Measure |
Arm I
Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
eribulin mesylate: Given IV
|
|---|---|
|
Overall Study
STARTED
|
66
|
|
Overall Study
COMPLETED
|
66
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
E7389 in Treating Patients With Recurrent or Progressive Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm I
n=66 Participants
Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
eribulin mesylate: Given IV
|
|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
66 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Tumor measurements repeated every 6 weeksPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Arm I
n=66 Participants
Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
eribulin mesylate: Given IV
|
|---|---|
|
Objective Response Rate (CR or PR) According to RECIST Criteria
|
5 percentage of patients responding
|
SECONDARY outcome
Timeframe: From start of treatment to death from any cause, assessed up to 5 yearsWill be estimated using the product-limit method of Kaplan and Meier.
Outcome measures
| Measure |
Arm I
n=66 Participants
Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
eribulin mesylate: Given IV
|
|---|---|
|
Overall Survival
|
11.6 Months
Interval 8.2 to 13.7
|
SECONDARY outcome
Timeframe: From start of treatment to the time of documented progression, assessed up to 5 yearsWill be estimated using the product-limit method of Kaplan and Meier.
Outcome measures
| Measure |
Arm I
n=66 Participants
Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
eribulin mesylate: Given IV
|
|---|---|
|
Progression Free Survival
|
2.7 Months
Interval 1.3 to 3.9
|
Adverse Events
Arm I
Serious events: 23 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I
n=66 participants at risk
Patients receive eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
eribulin mesylate: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Endocrine disorders
Adrenal insufficiency
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Constipation
|
4.5%
3/66 • Number of events 3 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
4.5%
3/66 • Number of events 3 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Death
|
3.0%
2/66 • Number of events 2 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Disease progression
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fatigue
|
4.5%
3/66 • Number of events 3 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Immune system disorders
Hypersensitivity
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Laryngitis
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Leukocyte count decreased
|
3.0%
2/66 • Number of events 3 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Leukopenia
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Neutrophil count decreased
|
19.7%
13/66 • Number of events 19 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
3.0%
2/66 • Number of events 2 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Depressed level of consciousness
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Intracranial hemorrhage
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Insomnia
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.0%
2/66 • Number of events 2 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.0%
2/66 • Number of events 2 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Other adverse events
| Measure |
Arm I
n=66 participants at risk
Patients receive eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
eribulin mesylate: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
69.7%
46/66 • Number of events 159 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Cardiac disorder
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Left ventricular failure
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Palpitations
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Pericardial effusion
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
4.5%
3/66 • Number of events 4 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
Hearing loss
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Dry eye syndrome
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Extraocular muscle paresis
|
1.5%
1/66 • Number of events 3 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Eye disorder
|
1.5%
1/66 • Number of events 2 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Vision blurred
|
4.5%
3/66 • Number of events 4 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Watering eyes
|
3.0%
2/66 • Number of events 7 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.2%
10/66 • Number of events 14 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Ascites
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Constipation
|
25.8%
17/66 • Number of events 29 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
10.6%
7/66 • Number of events 18 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.6%
7/66 • Number of events 11 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
3.0%
2/66 • Number of events 3 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
12.1%
8/66 • Number of events 10 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Esophageal pain
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastritis
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
3.0%
2/66 • Number of events 3 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
3.0%
2/66 • Number of events 2 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
24.2%
16/66 • Number of events 28 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Oral pain
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
12.1%
8/66 • Number of events 8 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chest pain
|
13.6%
9/66 • Number of events 14 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chills
|
3.0%
2/66 • Number of events 4 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Death
|
16.7%
11/66 • Number of events 11 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Disease progression
|
45.5%
30/66 • Number of events 30 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Edema limbs
|
16.7%
11/66 • Number of events 25 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fatigue
|
68.2%
45/66 • Number of events 137 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever
|
13.6%
9/66 • Number of events 14 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Gait abnormal
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
General symptom
|
6.1%
4/66 • Number of events 14 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Injection site reaction
|
1.5%
1/66 • Number of events 2 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Localized edema
|
1.5%
1/66 • Number of events 6 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Pain
|
10.6%
7/66 • Number of events 10 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Hepatobiliary disorders
Hepatic pain
|
3.0%
2/66 • Number of events 4 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Bronchitis
|
7.6%
5/66 • Number of events 5 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Catheter related infection
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Eye infection
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Infection
|
1.5%
1/66 • Number of events 14 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Paranasal sinus infection
|
1.5%
1/66 • Number of events 2 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Pneumonia
|
3.0%
2/66 • Number of events 3 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Sinusitis
|
3.0%
2/66 • Number of events 2 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Skin infection
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Upper respiratory infection
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Urinary tract infection
|
4.5%
3/66 • Number of events 3 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.5%
1/66 • Number of events 2 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
11/66 • Number of events 31 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alkaline phosphatase increased
|
18.2%
12/66 • Number of events 43 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
22.7%
15/66 • Number of events 25 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Bilirubin increased
|
7.6%
5/66 • Number of events 5 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Creatinine increased
|
3.0%
2/66 • Number of events 3 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Forced expiratory volume decreased
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
INR increased
|
3.0%
2/66 • Number of events 7 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Laboratory test abnormal
|
3.0%
2/66 • Number of events 4 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Leukocyte count decreased
|
57.6%
38/66 • Number of events 147 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Leukopenia
|
6.1%
4/66 • Number of events 6 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Lymphocyte count decreased
|
40.9%
27/66 • Number of events 104 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Neutrophil count decreased
|
57.6%
38/66 • Number of events 126 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelet count decreased
|
10.6%
7/66 • Number of events 10 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Serum cholesterol increased
|
3.0%
2/66 • Number of events 4 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight loss
|
6.1%
4/66 • Number of events 6 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
36.4%
24/66 • Number of events 49 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
6.1%
4/66 • Number of events 7 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
47.0%
31/66 • Number of events 84 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.1%
4/66 • Number of events 11 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.0%
2/66 • Number of events 2 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
30.3%
20/66 • Number of events 48 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
9.1%
6/66 • Number of events 7 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
9.1%
6/66 • Number of events 8 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
6.1%
4/66 • Number of events 5 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
7.6%
5/66 • Number of events 10 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
10.6%
7/66 • Number of events 13 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
13.6%
9/66 • Number of events 13 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
6.1%
4/66 • Number of events 6 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
18.2%
12/66 • Number of events 23 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
3.0%
2/66 • Number of events 4 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.2%
10/66 • Number of events 37 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.1%
6/66 • Number of events 10 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
10.6%
7/66 • Number of events 20 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint disorder
|
1.5%
1/66 • Number of events 2 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
12.1%
8/66 • Number of events 22 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
9.1%
6/66 • Number of events 8 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
4.5%
3/66 • Number of events 5 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.2%
12/66 • Number of events 26 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.0%
2/66 • Number of events 2 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
11/66 • Number of events 22 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Acoustic nerve disorder NOS
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Ataxia
|
1.5%
1/66 • Number of events 7 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Cognitive disturbance
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Depressed level of consciousness
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Dizziness
|
16.7%
11/66 • Number of events 15 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Headache
|
15.2%
10/66 • Number of events 15 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Neuralgia
|
1.5%
1/66 • Number of events 2 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Neurological disorder NOS
|
3.0%
2/66 • Number of events 3 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.0%
2/66 • Number of events 4 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
40.9%
27/66 • Number of events 67 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Seizure
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Syncope
|
3.0%
2/66 • Number of events 2 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Taste alteration
|
3.0%
2/66 • Number of events 7 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Tremor
|
1.5%
1/66 • Number of events 2 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Anxiety
|
9.1%
6/66 • Number of events 20 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Confusion
|
3.0%
2/66 • Number of events 2 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Depression
|
7.6%
5/66 • Number of events 8 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Insomnia
|
9.1%
6/66 • Number of events 9 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Glomerular filtration rate decreased
|
1.5%
1/66 • Number of events 3 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Protein urine positive
|
4.5%
3/66 • Number of events 4 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urethral pain
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urinary frequency
|
1.5%
1/66 • Number of events 2 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Testicular pain
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.6%
5/66 • Number of events 13 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
7.6%
5/66 • Number of events 14 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
42.4%
28/66 • Number of events 56 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
22/66 • Number of events 70 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
3.0%
2/66 • Number of events 2 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.0%
2/66 • Number of events 3 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
4.5%
3/66 • Number of events 6 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract hemorrhage
|
3.0%
2/66 • Number of events 2 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
6.1%
4/66 • Number of events 12 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
21.2%
14/66 • Number of events 54 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.0%
2/66 • Number of events 7 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
1.5%
1/66 • Number of events 5 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.5%
1/66 • Number of events 1 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
9.1%
6/66 • Number of events 7 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
3.0%
2/66 • Number of events 2 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Flushing
|
1.5%
1/66 • Number of events 2 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypertension
|
3.0%
2/66 • Number of events 2 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypotension
|
4.5%
3/66 • Number of events 6 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Phlebitis
|
1.5%
1/66 • Number of events 5 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Thrombosis
|
1.5%
1/66 • Number of events 6 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Vascular disorder
|
3.0%
2/66 • Number of events 5 • Adverse Events were recorded over a 40 month period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60