Trial Outcomes & Findings for AZD2171 in Treating Patients With Recurrent Small Cell Lung Cancer (NCT NCT00245063)
NCT ID: NCT00245063
Last Updated: 2014-10-02
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
25 participants
Primary outcome timeframe
Up to 4 weeks
Results posted on
2014-10-02
Participant Flow
Participant milestones
| Measure |
Arm A
Patients receive oral AZD2171 45 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given PO
|
Arm B
Patients receive oral AZD2171 30 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given PO
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
|
Overall Study
COMPLETED
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
| Measure |
Arm A
Patients receive oral AZD2171 45 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given PO
|
Arm B
Patients receive oral AZD2171 30 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given PO
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
5
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
AZD2171 in Treating Patients With Recurrent Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm A
n=12 Participants
Patients receive oral AZD2171 45 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given PO
|
Arm B
n=13 Participants
Patients receive oral AZD2171 30 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given PO
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
60 years
n=7 Participants
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 4 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 A
n=12 Participants
Patients receive oral AZD2171 45 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given PO
|
Arm B
n=13 Participants
Patients receive oral AZD2171 30 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given PO
|
|---|---|---|
|
Objective Response Rate
|
0 percentage of responding patients
|
0 percentage of responding patients
|
Adverse Events
Arm A
Serious events: 5 serious events
Other events: 12 other events
Deaths: 0 deaths
Arm B
Serious events: 5 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A
n=12 participants at risk
Patients receive oral AZD2171 45 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given PO
|
Arm B
n=13 participants at risk
Patients receive oral AZD2171 30 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given PO
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
General disorders
Disease progression
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
15.4%
2/13 • Number of events 2
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
General disorders
Fatigue
|
16.7%
2/12 • Number of events 2
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
General disorders
Pain
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Nervous system disorders
Neurological disorder NOS
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Renal and urinary disorders
Proteinuria
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
23.1%
3/13 • Number of events 3
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
Other adverse events
| Measure |
Arm A
n=12 participants at risk
Patients receive oral AZD2171 45 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given PO
|
Arm B
n=13 participants at risk
Patients receive oral AZD2171 30 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given PO
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
25.0%
3/12 • Number of events 5
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
23.1%
3/13 • Number of events 10
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 3
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Endocrine disorders
Hyperthyroidism
|
8.3%
1/12 • Number of events 2
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
15.4%
2/13 • Number of events 5
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Eye disorders
Cataract
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
6/12 • Number of events 7
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
3/12 • Number of events 3
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
46.2%
6/13 • Number of events 14
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Gastrointestinal disorders
Diarrhea
|
58.3%
7/12 • Number of events 14
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
53.8%
7/13 • Number of events 12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
2/12 • Number of events 2
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
23.1%
3/13 • Number of events 6
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
2/12 • Number of events 2
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Gastrointestinal disorders
Dysphagia
|
25.0%
3/12 • Number of events 3
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
8.3%
1/12 • Number of events 2
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Gastrointestinal disorders
Mucositis oral
|
8.3%
1/12 • Number of events 2
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
4/12 • Number of events 4
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
61.5%
8/13 • Number of events 14
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 2
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
30.8%
4/13 • Number of events 9
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
General disorders
Chest pain
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
15.4%
2/13 • Number of events 3
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
General disorders
Chills
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
15.4%
2/13 • Number of events 2
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
General disorders
Disease progression
|
66.7%
8/12 • Number of events 8
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
53.8%
7/13 • Number of events 7
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
General disorders
Edema limbs
|
16.7%
2/12 • Number of events 2
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
General disorders
Fatigue
|
66.7%
8/12 • Number of events 15
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
76.9%
10/13 • Number of events 26
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
General disorders
Fever
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
15.4%
2/13 • Number of events 2
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
General disorders
Pain
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
30.8%
4/13 • Number of events 14
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Infections and infestations
Bladder infection
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 4
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Infections and infestations
Gingival infection
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 3
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 3
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
15.4%
2/13 • Number of events 2
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
2/12 • Number of events 5
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
15.4%
2/13 • Number of events 3
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
2/12 • Number of events 5
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
38.5%
5/13 • Number of events 10
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
3/12 • Number of events 7
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
23.1%
3/13 • Number of events 4
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Investigations
Bilirubin increased
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 3
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Investigations
Creatinine increased
|
33.3%
4/12 • Number of events 6
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
23.1%
3/13 • Number of events 9
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Investigations
Hyperbilirubinemia
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Investigations
INR increased
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Investigations
Laboratory test abnormal
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Investigations
Leukopenia
|
16.7%
2/12 • Number of events 4
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 3
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Investigations
Lymphopenia
|
25.0%
3/12 • Number of events 7
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Investigations
Neutrophil count decreased
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Investigations
Platelet count decreased
|
25.0%
3/12 • Number of events 5
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Investigations
Serum cholesterol increased
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Investigations
Weight gain
|
8.3%
1/12 • Number of events 2
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Investigations
Weight loss
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
30.8%
4/13 • Number of events 8
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Metabolism and nutrition disorders
Anorexia
|
41.7%
5/12 • Number of events 8
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
38.5%
5/13 • Number of events 9
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
30.8%
4/13 • Number of events 5
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
3/12 • Number of events 3
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 2
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
41.7%
5/12 • Number of events 10
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
3/12 • Number of events 8
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
2/12 • Number of events 3
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.3%
1/12 • Number of events 2
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
2/12 • Number of events 2
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
23.1%
3/13 • Number of events 4
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
15.4%
2/13 • Number of events 2
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
3/12 • Number of events 4
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
15.4%
2/13 • Number of events 4
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
41.7%
5/12 • Number of events 8
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
2/12 • Number of events 4
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Musculoskeletal and connective tissue disorders
Upper extremity dysfunction
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 2
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 2
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
23.1%
3/13 • Number of events 8
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • Number of events 3
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
15.4%
2/13 • Number of events 4
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
15.4%
2/13 • Number of events 9
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Nervous system disorders
Taste alteration
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
15.4%
2/13 • Number of events 5
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Psychiatric disorders
Depression
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 3
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Renal and urinary disorders
Protein urine positive
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
30.8%
4/13 • Number of events 5
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Renal and urinary disorders
Proteinuria
|
41.7%
5/12 • Number of events 10
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Renal and urinary disorders
Urinary frequency
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
2/12 • Number of events 2
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
30.8%
4/13 • Number of events 9
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
4/12 • Number of events 6
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
46.2%
6/13 • Number of events 12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract hemorrhage
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 3
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
41.7%
5/12 • Number of events 10
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
23.1%
3/13 • Number of events 4
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
2/12 • Number of events 4
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
25.0%
3/12 • Number of events 3
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
8.3%
1/12 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
15.4%
2/13 • Number of events 3
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 3
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
0.00%
0/12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
7.7%
1/13 • Number of events 1
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Vascular disorders
Hypertension
|
50.0%
6/12 • Number of events 11
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
46.2%
6/13 • Number of events 12
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • Number of events 2
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
0.00%
0/13
"Other" adverse events include all grades and attributions to treatment not included in the "Serious" table.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60