Trial Outcomes & Findings for Aflibercept in Treating Patients With Myelodysplastic Syndromes (NCT NCT00509249)
NCT ID: NCT00509249
Last Updated: 2015-01-08
Results Overview
Complete Response (CR): repeat bone marrow (BM) shows \<5% myeloblasts, and peripheral blood values lasting ≥ 2 months of hemoglobin (hgb) (\>110 g/L), neutrophils (≥1.0x10\^9/L), platelets (≥100x10\^9/L), blasts (0%) and no dysplasia. Partial Response (PR): same as CR for peripheral blood except BM shows blasts decrease by ≥ 50% but still \> 5% or a less advanced FAB classification from pretreatment. Hematological response=CR+PR.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2015-01-08
Participant Flow
Participant milestones
| Measure |
Arm I
Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Aflibercept in Treating Patients With Myelodysplastic Syndromes
Baseline characteristics by cohort
| Measure |
Arm I
n=18 Participants
Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Age, Continuous
|
71 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsComplete Response (CR): repeat bone marrow (BM) shows \<5% myeloblasts, and peripheral blood values lasting ≥ 2 months of hemoglobin (hgb) (\>110 g/L), neutrophils (≥1.0x10\^9/L), platelets (≥100x10\^9/L), blasts (0%) and no dysplasia. Partial Response (PR): same as CR for peripheral blood except BM shows blasts decrease by ≥ 50% but still \> 5% or a less advanced FAB classification from pretreatment. Hematological response=CR+PR.
Outcome measures
| Measure |
Arm I
n=18 Participants
Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Hematological Response Rate
|
0 participants
|
Adverse Events
Arm I
Serious events: 7 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I
n=18 participants at risk
Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Cardiac disorders
Conduction disorder
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Hepatobiliary disorders
Cholecystitis
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Infections and infestations
Pneumonia
|
11.1%
2/18 • Number of events 2
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Infections and infestations
Sepsis
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Investigations
Cardiac troponin I increased
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Investigations
Creatinine increased
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Investigations
Platelet count decreased
|
11.1%
2/18 • Number of events 2
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Nervous system disorders
Syncope
|
11.1%
2/18 • Number of events 2
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Psychiatric disorders
Confusion
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Vascular disorders
Hematoma
|
11.1%
2/18 • Number of events 3
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
Other adverse events
| Measure |
Arm I
n=18 participants at risk
Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Infections and infestations
Wound infection
|
5.6%
1/18 • Number of events 2
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Injury, poisoning and procedural complications
Bruising
|
22.2%
4/18 • Number of events 17
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Injury, poisoning and procedural complications
Fracture
|
5.6%
1/18 • Number of events 4
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
5.6%
1/18 • Number of events 12
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
6/18 • Number of events 14
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Investigations
Alkaline phosphatase increased
|
22.2%
4/18 • Number of events 5
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Investigations
Aspartate aminotransferase increased
|
44.4%
8/18 • Number of events 19
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Investigations
Bilirubin increased
|
16.7%
3/18 • Number of events 7
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
38.9%
7/18 • Number of events 15
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
11.1%
2/18 • Number of events 2
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
16.7%
3/18 • Number of events 5
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
16.7%
3/18 • Number of events 18
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
11.1%
2/18 • Number of events 4
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
33.3%
6/18 • Number of events 21
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
27.8%
5/18 • Number of events 24
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.6%
1/18 • Number of events 3
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
5.6%
1/18 • Number of events 13
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.6%
1/18 • Number of events 7
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
3/18 • Number of events 3
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Nervous system disorders
Ataxia
|
5.6%
1/18 • Number of events 2
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Nervous system disorders
Depressed level of consciousness
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Nervous system disorders
Dizziness
|
16.7%
3/18 • Number of events 18
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Nervous system disorders
Headache
|
50.0%
9/18 • Number of events 30
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Nervous system disorders
Neurological disorder NOS
|
5.6%
1/18 • Number of events 2
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.6%
1/18 • Number of events 4
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Investigations
Carbon monoxide diffusing capacity decreased
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Investigations
Cardiac troponin I increased
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Investigations
Coagulopathy
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Investigations
Creatinine increased
|
22.2%
4/18 • Number of events 17
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Investigations
Electrocardiogram QTc interval prolonged
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Investigations
Laboratory test abnormal
|
5.6%
1/18 • Number of events 2
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Investigations
Leukocyte count decreased
|
44.4%
8/18 • Number of events 52
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Investigations
Lymphocyte count decreased
|
22.2%
4/18 • Number of events 20
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Investigations
Neutrophil count decreased
|
50.0%
9/18 • Number of events 51
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Investigations
Platelet count decreased
|
61.1%
11/18 • Number of events 74
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Investigations
Weight loss
|
11.1%
2/18 • Number of events 5
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Metabolism and nutrition disorders
Anorexia
|
27.8%
5/18 • Number of events 10
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
33.3%
6/18 • Number of events 13
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.6%
1/18 • Number of events 2
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
83.3%
15/18 • Number of events 107
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
5.6%
1/18 • Number of events 2
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Cardiac disorders
Cardiac disorder
|
5.6%
1/18 • Number of events 4
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Cardiac disorders
Cardiac pain
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Cardiac disorders
Palpitations
|
11.1%
2/18 • Number of events 3
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Cardiac disorders
Sinus bradycardia
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Cardiac disorders
Sinus tachycardia
|
11.1%
2/18 • Number of events 2
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Ear and labyrinth disorders
Tinnitus
|
5.6%
1/18 • Number of events 7
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Eye disorders
Flashing vision
|
5.6%
1/18 • Number of events 6
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Gastrointestinal disorders
Abdominal pain
|
27.8%
5/18 • Number of events 7
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Gastrointestinal disorders
Constipation
|
27.8%
5/18 • Number of events 20
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Gastrointestinal disorders
Diarrhea
|
27.8%
5/18 • Number of events 14
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Gastrointestinal disorders
Dysphagia
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Gastrointestinal disorders
Fecal incontinence
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Gastrointestinal disorders
Flatulence
|
11.1%
2/18 • Number of events 6
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
5.6%
1/18 • Number of events 2
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Gastrointestinal disorders
Gingival pain
|
5.6%
1/18 • Number of events 3
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
11.1%
2/18 • Number of events 3
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Gastrointestinal disorders
Nausea
|
38.9%
7/18 • Number of events 12
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Gastrointestinal disorders
Stomach pain
|
5.6%
1/18 • Number of events 3
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Gastrointestinal disorders
Toothache
|
5.6%
1/18 • Number of events 3
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
3/18 • Number of events 8
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
General disorders
Chest pain
|
11.1%
2/18 • Number of events 2
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
General disorders
Chills
|
22.2%
4/18 • Number of events 9
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
General disorders
Disease progression
|
16.7%
3/18 • Number of events 3
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
General disorders
Edema limbs
|
33.3%
6/18 • Number of events 33
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
General disorders
Fatigue
|
66.7%
12/18 • Number of events 36
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
General disorders
Fever
|
16.7%
3/18 • Number of events 4
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
General disorders
Flu-like symptoms
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
General disorders
Ill-defined disorder
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
General disorders
Pain
|
16.7%
3/18 • Number of events 5
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Infections and infestations
Abdominal infection
|
5.6%
1/18 • Number of events 5
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Infections and infestations
Gingival infection
|
5.6%
1/18 • Number of events 2
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Infections and infestations
Joint infection
|
5.6%
1/18 • Number of events 3
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Infections and infestations
Opportunistic infection
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Infections and infestations
Paranasal sinus infection
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Infections and infestations
Pneumonia
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Infections and infestations
Sinusitis
|
11.1%
2/18 • Number of events 3
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Infections and infestations
Upper respiratory infection
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Infections and infestations
Urinary tract infection
|
27.8%
5/18 • Number of events 5
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Infections and infestations
Vaginal infection
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Nervous system disorders
Seizure
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Nervous system disorders
Speech disorder
|
11.1%
2/18 • Number of events 8
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Nervous system disorders
Taste alteration
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Psychiatric disorders
Anxiety
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Psychiatric disorders
Confusion
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Psychiatric disorders
Depression
|
5.6%
1/18 • Number of events 12
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Psychiatric disorders
Insomnia
|
11.1%
2/18 • Number of events 6
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
5.6%
1/18 • Number of events 2
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Renal and urinary disorders
Protein urine positive
|
27.8%
5/18 • Number of events 16
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Renal and urinary disorders
Urinary frequency
|
11.1%
2/18 • Number of events 15
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Renal and urinary disorders
Urinary incontinence
|
11.1%
2/18 • Number of events 5
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Reproductive system and breast disorders
Pelvic pain
|
11.1%
2/18 • Number of events 2
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
22.2%
4/18 • Number of events 20
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
6/18 • Number of events 13
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
27.8%
5/18 • Number of events 22
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
22.2%
4/18 • Number of events 6
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
11.1%
2/18 • Number of events 2
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
11.1%
2/18 • Number of events 5
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract hemorrhage
|
5.6%
1/18 • Number of events 2
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
27.8%
5/18 • Number of events 55
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.6%
1/18 • Number of events 1
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.6%
1/18 • Number of events 4
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
16.7%
3/18 • Number of events 3
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
1/18 • Number of events 8
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
22.2%
4/18 • Number of events 7
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
5.6%
1/18 • Number of events 3
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
5.6%
1/18 • Number of events 2
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
27.8%
5/18 • Number of events 17
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
16.7%
3/18 • Number of events 17
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Vascular disorders
Hematoma
|
11.1%
2/18 • Number of events 15
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Vascular disorders
Hypertension
|
44.4%
8/18 • Number of events 44
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
|
Vascular disorders
Lymphedema
|
5.6%
1/18 • Number of events 3
"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60