Trial Outcomes & Findings for Bevacizumab and Temozolomide or Bevacizumab and Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin in Treating Patients With Stage IV Malignant Melanoma That Cannot Be Removed by Surgery (NCT NCT00626405)
NCT ID: NCT00626405
Last Updated: 2018-05-01
Results Overview
The primary endpoint is the 6 month post registration Progression-free survival (PFS) rate. Progression-free survival time is defined as the time from registration to documentation of disease progression using the RECIST criteria. Patients who died without documentation of disease progression will be considered to have progressed at death unless there is sufficient documented evidence to conclude no progression occurred prior to death. All patients, who meet the eligibility criteria, sign a consent form, and start treatment will be included in the evaluation of the 6 month PFS rate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
95 participants
Primary outcome timeframe
at 6 months
Results posted on
2018-05-01
Participant Flow
Participant milestones
| Measure |
Arm I
Patients receive oral temozolomide on days 1-5 and bevacizumab IV over 30-90 minutes on days 1 and 15.\> \> bevacizumab: Given IV over 30-90 minutes\>
\> temozolomide: Oral temozolomide on days 1-5
|
Arm II
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1.\>
\> bevacizumab: Given IV over 30-90 minutes\>
\> carboplatin: Given IV over 30 minutes\>
\> paclitaxel albumin-stabilized nanoparticle formulation: Given IV over 30 minutes
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
52
|
|
Overall Study
COMPLETED
|
42
|
51
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Arm I
Patients receive oral temozolomide on days 1-5 and bevacizumab IV over 30-90 minutes on days 1 and 15.\> \> bevacizumab: Given IV over 30-90 minutes\>
\> temozolomide: Oral temozolomide on days 1-5
|
Arm II
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1.\>
\> bevacizumab: Given IV over 30-90 minutes\>
\> carboplatin: Given IV over 30 minutes\>
\> paclitaxel albumin-stabilized nanoparticle formulation: Given IV over 30 minutes
|
|---|---|---|
|
Overall Study
Deemed Ineligible
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Bevacizumab and Temozolomide or Bevacizumab and Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin in Treating Patients With Stage IV Malignant Melanoma That Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Arm I
n=42 Participants
Patients receive oral temozolomide on days 1-5 and bevacizumab IV over 30-90 minutes on days 1 and 15.\> \> bevacizumab: Given IV over 30-90 minutes\>
\> temozolomide: Oral temozolomide on days 1-5
|
Arm II
n=51 Participants
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1.\>
\> bevacizumab: Given IV over 30-90 minutes\>
\> carboplatin: Given IV over 30 minutes\>
\> paclitaxel albumin-stabilized nanoparticle formulation: Given IV over 30 minutes
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 Years
n=5 Participants
|
57 Years
n=7 Participants
|
57 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 6 monthsPopulation: The first 41 eligible patients randomized to each treatment arm.
The primary endpoint is the 6 month post registration Progression-free survival (PFS) rate. Progression-free survival time is defined as the time from registration to documentation of disease progression using the RECIST criteria. Patients who died without documentation of disease progression will be considered to have progressed at death unless there is sufficient documented evidence to conclude no progression occurred prior to death. All patients, who meet the eligibility criteria, sign a consent form, and start treatment will be included in the evaluation of the 6 month PFS rate.
Outcome measures
| Measure |
Arm I
n=41 Participants
Patients receive oral temozolomide on days 1-5 and bevacizumab IV over 30-90 minutes on days 1 and 15.
\>
\> bevacizumab: Given IV over 30-90 minutes
\>
\> temozolomide: Oral temozolomide on days 1-5
|
Arm II
n=41 Participants
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1.
\>
\> bevacizumab: Given IV over 30-90 minutes
\>
\> carboplatin: Given IV over 30 minutes
\>
\> paclitaxel albumin-stabilized nanoparticle formulation: Given IV over 30 minutes
|
|---|---|---|
|
Progression-free Survival at 6 Months
|
32.8 % of patients alive and progression free
Interval 21.1 to 51.2
|
56.1 % of patients alive and progression free
Interval 44.7 to 70.4
|
SECONDARY outcome
Timeframe: Up to 5 yearsA confirmed tumor response is defined to be a Complete Response or Partial Response noted \> as the objective status on 2 consecutive evaluations at least 8 \> weeks apart. The proportion of tumor responses will be \> estimated by the number of confirmed tumor responses divided \> by the total number of evaluable patients. \> Complete Response (CR): Disappearance of all target lesions \> Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. \> Progression (PD): At least a 20% increase in the sum of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. \> Stable Disease (SD): Neither sufficient shrinkage to Qualify for PR nor sufficient increase to Qualify for PD taking as reference the smallest sum LD. responses will be calculated assuming that the number of \> confirmed tumor responses follows a binomial distribution.
Outcome measures
| Measure |
Arm I
n=42 Participants
Patients receive oral temozolomide on days 1-5 and bevacizumab IV over 30-90 minutes on days 1 and 15.
\>
\> bevacizumab: Given IV over 30-90 minutes
\>
\> temozolomide: Oral temozolomide on days 1-5
|
Arm II
n=51 Participants
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1.
\>
\> bevacizumab: Given IV over 30-90 minutes
\>
\> carboplatin: Given IV over 30 minutes
\>
\> paclitaxel albumin-stabilized nanoparticle formulation: Given IV over 30 minutes
|
|---|---|---|
|
Tumor Response Rate, Calculated as a Percentage Along With it's 95% Confidence Interval
|
23.8 percentage of patients with response
Interval 12.1 to 39.5
|
33.3 percentage of patients with response
Interval 20.8 to 47.9
|
SECONDARY outcome
Timeframe: Up to 5 yearsOverall survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Arm I
n=42 Participants
Patients receive oral temozolomide on days 1-5 and bevacizumab IV over 30-90 minutes on days 1 and 15.
\>
\> bevacizumab: Given IV over 30-90 minutes
\>
\> temozolomide: Oral temozolomide on days 1-5
|
Arm II
n=51 Participants
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1.
\>
\> bevacizumab: Given IV over 30-90 minutes
\>
\> carboplatin: Given IV over 30 minutes
\>
\> paclitaxel albumin-stabilized nanoparticle formulation: Given IV over 30 minutes
|
|---|---|---|
|
Overall Survival
|
12.3 Months
Interval 9.3 to 15.3
|
13.9 Months
Interval 9.8 to 15.5
|
Adverse Events
Arm I
Serious events: 7 serious events
Other events: 43 other events
Deaths: 0 deaths
Arm II
Serious events: 18 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I
n=43 participants at risk
temozolomide: Oral temozolomide on days 1-5
|
Arm II
n=51 participants at risk
paclitaxel albumin-stabilized nanoparticle formulation: Given IV over 30 minutes
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
2.3%
1/43 • Number of events 1 • Until treatment discontinuation
|
0.00%
0/51 • Until treatment discontinuation
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
4.7%
2/43 • Number of events 2 • Until treatment discontinuation
|
9.8%
5/51 • Number of events 5 • Until treatment discontinuation
|
|
Cardiac disorders
Arrhythmia
|
2.3%
1/43 • Number of events 1 • Until treatment discontinuation
|
0.00%
0/51 • Until treatment discontinuation
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Gastrointestinal disorders
Ileal obstruction
|
2.3%
1/43 • Number of events 1 • Until treatment discontinuation
|
0.00%
0/51 • Until treatment discontinuation
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
2.3%
1/43 • Number of events 1 • Until treatment discontinuation
|
0.00%
0/51 • Until treatment discontinuation
|
|
Gastrointestinal disorders
Nausea
|
4.7%
2/43 • Number of events 2 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 2 • Until treatment discontinuation
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
1/43 • Number of events 1 • Until treatment discontinuation
|
0.00%
0/51 • Until treatment discontinuation
|
|
General disorders
Chest pain
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
General disorders
Fatigue
|
4.7%
2/43 • Number of events 2 • Until treatment discontinuation
|
0.00%
0/51 • Until treatment discontinuation
|
|
General disorders
Fever
|
2.3%
1/43 • Number of events 1 • Until treatment discontinuation
|
0.00%
0/51 • Until treatment discontinuation
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Infections and infestations
Pneumonia
|
2.3%
1/43 • Number of events 1 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Infections and infestations
Urinary tract infection
|
2.3%
1/43 • Number of events 1 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Investigations
Leukocyte count decreased
|
4.7%
2/43 • Number of events 2 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Investigations
Neutrophil count decreased
|
4.7%
2/43 • Number of events 2 • Until treatment discontinuation
|
13.7%
7/51 • Number of events 7 • Until treatment discontinuation
|
|
Investigations
Platelet count decreased
|
7.0%
3/43 • Number of events 3 • Until treatment discontinuation
|
9.8%
5/51 • Number of events 5 • Until treatment discontinuation
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/43 • Number of events 1 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.3%
1/43 • Number of events 1 • Until treatment discontinuation
|
0.00%
0/51 • Until treatment discontinuation
|
|
Nervous system disorders
Seizure
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.3%
1/43 • Number of events 1 • Until treatment discontinuation
|
0.00%
0/51 • Until treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/43 • Until treatment discontinuation
|
5.9%
3/51 • Number of events 3 • Until treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 2 • Until treatment discontinuation
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.3%
1/43 • Number of events 1 • Until treatment discontinuation
|
0.00%
0/51 • Until treatment discontinuation
|
|
Vascular disorders
Hypertension
|
4.7%
2/43 • Number of events 2 • Until treatment discontinuation
|
0.00%
0/51 • Until treatment discontinuation
|
|
Vascular disorders
Hypotension
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Vascular disorders
Thrombosis
|
0.00%
0/43 • Until treatment discontinuation
|
3.9%
2/51 • Number of events 2 • Until treatment discontinuation
|
Other adverse events
| Measure |
Arm I
n=43 participants at risk
temozolomide: Oral temozolomide on days 1-5
|
Arm II
n=51 participants at risk
paclitaxel albumin-stabilized nanoparticle formulation: Given IV over 30 minutes
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
62.8%
27/43 • Number of events 79 • Until treatment discontinuation
|
90.2%
46/51 • Number of events 279 • Until treatment discontinuation
|
|
Eye disorders
Diplopia
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Eye disorders
Vision blurred
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 8 • Until treatment discontinuation
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Gastrointestinal disorders
Abdominal pain
|
7.0%
3/43 • Number of events 4 • Until treatment discontinuation
|
5.9%
3/51 • Number of events 7 • Until treatment discontinuation
|
|
Gastrointestinal disorders
Constipation
|
4.7%
2/43 • Number of events 3 • Until treatment discontinuation
|
11.8%
6/51 • Number of events 10 • Until treatment discontinuation
|
|
Gastrointestinal disorders
Diarrhea
|
2.3%
1/43 • Number of events 1 • Until treatment discontinuation
|
3.9%
2/51 • Number of events 2 • Until treatment discontinuation
|
|
Gastrointestinal disorders
Dyspepsia
|
2.3%
1/43 • Number of events 2 • Until treatment discontinuation
|
3.9%
2/51 • Number of events 2 • Until treatment discontinuation
|
|
Gastrointestinal disorders
Esophageal stenosis
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Gastrointestinal disorders
Esophageal varices hemorrhage
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
4.7%
2/43 • Number of events 4 • Until treatment discontinuation
|
7.8%
4/51 • Number of events 9 • Until treatment discontinuation
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/43 • Until treatment discontinuation
|
5.9%
3/51 • Number of events 9 • Until treatment discontinuation
|
|
Gastrointestinal disorders
Nausea
|
74.4%
32/43 • Number of events 130 • Until treatment discontinuation
|
62.7%
32/51 • Number of events 94 • Until treatment discontinuation
|
|
Gastrointestinal disorders
Oral cavity fistula
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Gastrointestinal disorders
Vomiting
|
46.5%
20/43 • Number of events 42 • Until treatment discontinuation
|
29.4%
15/51 • Number of events 37 • Until treatment discontinuation
|
|
General disorders
Disease progression
|
2.3%
1/43 • Number of events 1 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
General disorders
Edema limbs
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
General disorders
Fatigue
|
97.7%
42/43 • Number of events 207 • Until treatment discontinuation
|
94.1%
48/51 • Number of events 254 • Until treatment discontinuation
|
|
General disorders
Fever
|
20.9%
9/43 • Number of events 10 • Until treatment discontinuation
|
15.7%
8/51 • Number of events 8 • Until treatment discontinuation
|
|
Immune system disorders
Hypersensitivity
|
7.0%
3/43 • Number of events 5 • Until treatment discontinuation
|
9.8%
5/51 • Number of events 7 • Until treatment discontinuation
|
|
Infections and infestations
Infection
|
0.00%
0/43 • Until treatment discontinuation
|
3.9%
2/51 • Number of events 2 • Until treatment discontinuation
|
|
Infections and infestations
Pleural infection
|
2.3%
1/43 • Number of events 1 • Until treatment discontinuation
|
0.00%
0/51 • Until treatment discontinuation
|
|
Infections and infestations
Pneumonia
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Infections and infestations
Scrotal infection
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Infections and infestations
Sinusitis
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Infections and infestations
Skin infection
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/43 • Until treatment discontinuation
|
5.9%
3/51 • Number of events 3 • Until treatment discontinuation
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
2.3%
1/43 • Number of events 1 • Until treatment discontinuation
|
5.9%
3/51 • Number of events 4 • Until treatment discontinuation
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Investigations
Alkaline phosphatase increased
|
4.7%
2/43 • Number of events 2 • Until treatment discontinuation
|
0.00%
0/51 • Until treatment discontinuation
|
|
Investigations
Aspartate aminotransferase increased
|
2.3%
1/43 • Number of events 1 • Until treatment discontinuation
|
0.00%
0/51 • Until treatment discontinuation
|
|
Investigations
Bilirubin increased
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Investigations
Leukocyte count decreased
|
34.9%
15/43 • Number of events 45 • Until treatment discontinuation
|
74.5%
38/51 • Number of events 191 • Until treatment discontinuation
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/43 • Until treatment discontinuation
|
7.8%
4/51 • Number of events 11 • Until treatment discontinuation
|
|
Investigations
Neutrophil count decreased
|
16.3%
7/43 • Number of events 8 • Until treatment discontinuation
|
70.6%
36/51 • Number of events 159 • Until treatment discontinuation
|
|
Investigations
Platelet count decreased
|
39.5%
17/43 • Number of events 64 • Until treatment discontinuation
|
58.8%
30/51 • Number of events 145 • Until treatment discontinuation
|
|
Investigations
Weight loss
|
0.00%
0/43 • Until treatment discontinuation
|
9.8%
5/51 • Number of events 10 • Until treatment discontinuation
|
|
Metabolism and nutrition disorders
Anorexia
|
9.3%
4/43 • Number of events 4 • Until treatment discontinuation
|
13.7%
7/51 • Number of events 13 • Until treatment discontinuation
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
0.00%
0/43 • Until treatment discontinuation
|
5.9%
3/51 • Number of events 6 • Until treatment discontinuation
|
|
Metabolism and nutrition disorders
Dehydration
|
9.3%
4/43 • Number of events 4 • Until treatment discontinuation
|
7.8%
4/51 • Number of events 4 • Until treatment discontinuation
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
0.00%
0/43 • Until treatment discontinuation
|
3.9%
2/51 • Number of events 2 • Until treatment discontinuation
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
2.3%
1/43 • Number of events 1 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
2.3%
1/43 • Number of events 1 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
1/43 • Number of events 2 • Until treatment discontinuation
|
5.9%
3/51 • Number of events 7 • Until treatment discontinuation
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.3%
1/43 • Number of events 1 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
4.7%
2/43 • Number of events 2 • Until treatment discontinuation
|
0.00%
0/51 • Until treatment discontinuation
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
39.5%
17/43 • Number of events 69 • Until treatment discontinuation
|
39.2%
20/51 • Number of events 74 • Until treatment discontinuation
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
2.3%
1/43 • Number of events 1 • Until treatment discontinuation
|
0.00%
0/51 • Until treatment discontinuation
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
48.8%
21/43 • Number of events 66 • Until treatment discontinuation
|
35.3%
18/51 • Number of events 54 • Until treatment discontinuation
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.7%
2/43 • Number of events 2 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
2.3%
1/43 • Number of events 1 • Until treatment discontinuation
|
3.9%
2/51 • Number of events 4 • Until treatment discontinuation
|
|
Nervous system disorders
Acoustic nerve disorder NOS
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Nervous system disorders
Ataxia
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Nervous system disorders
Dizziness
|
4.7%
2/43 • Number of events 2 • Until treatment discontinuation
|
0.00%
0/51 • Until treatment discontinuation
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Nervous system disorders
Headache
|
2.3%
1/43 • Number of events 2 • Until treatment discontinuation
|
5.9%
3/51 • Number of events 14 • Until treatment discontinuation
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/43 • Until treatment discontinuation
|
3.9%
2/51 • Number of events 2 • Until treatment discontinuation
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 5 • Until treatment discontinuation
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.3%
1/43 • Number of events 1 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
23.3%
10/43 • Number of events 16 • Until treatment discontinuation
|
47.1%
24/51 • Number of events 85 • Until treatment discontinuation
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 2 • Until treatment discontinuation
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Nervous system disorders
Taste alteration
|
0.00%
0/43 • Until treatment discontinuation
|
3.9%
2/51 • Number of events 7 • Until treatment discontinuation
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Psychiatric disorders
Confusion
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Psychiatric disorders
Depression
|
2.3%
1/43 • Number of events 1 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Psychiatric disorders
Insomnia
|
2.3%
1/43 • Number of events 1 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Renal and urinary disorders
Protein urine positive
|
32.6%
14/43 • Number of events 29 • Until treatment discontinuation
|
37.3%
19/51 • Number of events 73 • Until treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.3%
1/43 • Number of events 1 • Until treatment discontinuation
|
0.00%
0/51 • Until treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
18.6%
8/43 • Number of events 20 • Until treatment discontinuation
|
29.4%
15/51 • Number of events 41 • Until treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.7%
2/43 • Number of events 2 • Until treatment discontinuation
|
11.8%
6/51 • Number of events 11 • Until treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
4.7%
2/43 • Number of events 2 • Until treatment discontinuation
|
0.00%
0/51 • Until treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/43 • Until treatment discontinuation
|
11.8%
6/51 • Number of events 19 • Until treatment discontinuation
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/43 • Until treatment discontinuation
|
3.9%
2/51 • Number of events 2 • Until treatment discontinuation
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/43 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
4.7%
2/43 • Number of events 3 • Until treatment discontinuation
|
0.00%
0/51 • Until treatment discontinuation
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
2.3%
1/43 • Number of events 1 • Until treatment discontinuation
|
2.0%
1/51 • Number of events 1 • Until treatment discontinuation
|
|
Vascular disorders
Hypertension
|
53.5%
23/43 • Number of events 62 • Until treatment discontinuation
|
35.3%
18/51 • Number of events 59 • Until treatment discontinuation
|
|
Vascular disorders
Thrombosis
|
7.0%
3/43 • Number of events 4 • Until treatment discontinuation
|
9.8%
5/51 • Number of events 7 • Until treatment discontinuation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place