Trial Outcomes & Findings for Phase II Study of Vandetanib in Individuals With Kidney Cancer (NCT NCT00566995)
NCT ID: NCT00566995
Last Updated: 2018-10-30
Results Overview
Overall response rate is defined as the percentage of participants with either a partial or complete response occurring at any time after initiation of therapy. Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete response (CR) is a disappearance of all target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD 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) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum LD since the treatment started.
COMPLETED
PHASE2
37 participants
Baseline and every 3 cycles, up to 2 years
2018-10-30
Participant Flow
Participant milestones
| Measure |
Vandetanib in Participants With Kidney Cancer
300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Vandetanib in Participants With Kidney Cancer
300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
|
|---|---|
|
Overall Study
Toxicity
|
4
|
|
Overall Study
Withdrew consent
|
3
|
Baseline Characteristics
Phase II Study of Vandetanib in Individuals With Kidney Cancer
Baseline characteristics by cohort
| Measure |
Vandetanib in Participants With Kidney Cancer
n=37 Participants
300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
46.65 years
STANDARD_DEVIATION 9.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and every 3 cycles, up to 2 yearsOverall response rate is defined as the percentage of participants with either a partial or complete response occurring at any time after initiation of therapy. Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete response (CR) is a disappearance of all target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD 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) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum LD since the treatment started.
Outcome measures
| Measure |
Vandetanib in Participants With Kidney Cancer
n=37 Participants
300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
|
|---|---|
|
Overall Response Rate.
Partial Response
|
3 percentage of participants
|
|
Overall Response Rate.
Complete Response
|
0 percentage of participants
|
|
Overall Response Rate.
Stable Disease
|
75 percentage of participants
|
|
Overall Response Rate.
Progressive Disease
|
0 percentage of participants
|
|
Overall Response Rate.
Not Evaluable
|
22 percentage of participants
|
SECONDARY outcome
Timeframe: 72 months and 14 daysHere is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
Vandetanib in Participants With Kidney Cancer
n=37 Participants
300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
|
|---|---|
|
Number of Participants With Adverse Events
|
37 Participants
|
SECONDARY outcome
Timeframe: Baseline and every 3 cycles while on study, up to 2 years.Time to progression is defined as the time from the start of treatment to progression as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, with death being treated as a censored event. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete response (CR) is a disappearance of all target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, the appearance of one or more new lesions, developing a surgical size tumor that should be resected. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum LD since the treatment started.
Outcome measures
| Measure |
Vandetanib in Participants With Kidney Cancer
n=37 Participants
300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
|
|---|---|
|
Time To Progression (TTP)
|
13.8 Months
Interval 11.0 to 22.1
|
SECONDARY outcome
Timeframe: Baseline and every 3 cycles while on study, up to 2 years.Progression free survival is defined as time from initiation of treatment to either progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or death. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete response (CR) is a disappearance of all target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD 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) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum LD since the treatment started.
Outcome measures
| Measure |
Vandetanib in Participants With Kidney Cancer
n=37 Participants
300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
|
|---|---|
|
Progression Free Survival (PFS)
|
13.8 Months
Interval 11.0 to 22.1
|
SECONDARY outcome
Timeframe: Pre treatment, 4 hours after first treatment, and after one cycle of treatment (one cycle = 28 days)Population: No samples were received for 2/37 patients.
Peripheral blood was collected and analyzed by multiparametric flow cytometry for analysis of angiogenesis markers.
Outcome measures
| Measure |
Vandetanib in Participants With Kidney Cancer
n=35 Participants
300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
|
|---|---|
|
Effect of Vandetanib (ZD6474) on Endothelial Progenitor Cells
Cycle 1 Day 1 Pre treatment
|
214.44 Cells per 10^6 mononuclear cells
Interval 0.0 to 906.7
|
|
Effect of Vandetanib (ZD6474) on Endothelial Progenitor Cells
Cycle 1 Day 1, 4 hours post
|
115.79 Cells per 10^6 mononuclear cells
Interval 0.0 to 282.69
|
|
Effect of Vandetanib (ZD6474) on Endothelial Progenitor Cells
Cycle 2 Day 1
|
160.20 Cells per 10^6 mononuclear cells
Interval 0.0 to 640.6
|
SECONDARY outcome
Timeframe: Pre treatment, 4 hours after first treatment, and after one cycle of treatment (one cycle = 28 days)Population: No samples were received for 2/37 participants.
Peripheral blood was collected and analyzed by multiparametric flow cytometry.
Outcome measures
| Measure |
Vandetanib in Participants With Kidney Cancer
n=35 Participants
300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
|
|---|---|
|
Effect of Vandetanib (ZD6474) on Circulating Endothelial Cells (CEC)
Cycle 1 day 1 Pre treatment
|
83.83 CEC per 10^6 mononuclear cells
Interval 0.0 to 314.2
|
|
Effect of Vandetanib (ZD6474) on Circulating Endothelial Cells (CEC)
Cycle 1 Day 1, 4 hours post
|
63.08 CEC per 10^6 mononuclear cells
Interval 0.0 to 307.4
|
|
Effect of Vandetanib (ZD6474) on Circulating Endothelial Cells (CEC)
Cycle 2 Day 1
|
155.8 CEC per 10^6 mononuclear cells
Interval 0.0 to 2480.0
|
SECONDARY outcome
Timeframe: Baseline and every 3 cycles while on study, up to 2 years.Population: Only two participants had target lesions that could be measured.
Tumor measurements for non-renal tumors were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) before and after treatment. Tumor measurements for non-renal tumors were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) before and after treatment. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest um LD recorded since treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Outcome measures
| Measure |
Vandetanib in Participants With Kidney Cancer
n=2 Participants
300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
|
|---|---|
|
Response in Pancreatic Tumors/Cysts Associated With Von Hippel Lindau (VHL)
Complete Response
|
0 Participants
|
|
Response in Pancreatic Tumors/Cysts Associated With Von Hippel Lindau (VHL)
Partial Response
|
0 Participants
|
|
Response in Pancreatic Tumors/Cysts Associated With Von Hippel Lindau (VHL)
Progressive Disease
|
0 Participants
|
|
Response in Pancreatic Tumors/Cysts Associated With Von Hippel Lindau (VHL)
Stable Disease
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and every 3 cycles while on study, up to 2 years.Population: Only two participants had target lesions that could be measured.
Tumor measurements for non-renal tumors were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) before and after treatment. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest um LD recorded since treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Outcome measures
| Measure |
Vandetanib in Participants With Kidney Cancer
n=2 Participants
300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
|
|---|---|
|
Response in Central Nervous System (CNS) Hemangioblastomas Associated With Von Hippel Lindau (VHL)
Complete Response
|
0 Participants
|
|
Response in Central Nervous System (CNS) Hemangioblastomas Associated With Von Hippel Lindau (VHL)
Partial Response
|
0 Participants
|
|
Response in Central Nervous System (CNS) Hemangioblastomas Associated With Von Hippel Lindau (VHL)
Progressive Disease
|
0 Participants
|
|
Response in Central Nervous System (CNS) Hemangioblastomas Associated With Von Hippel Lindau (VHL)
Stable Disease
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and every 3 cycles while on study, up to 2 years.Population: This outcome measure was not done because no participants had measurable lesions.
Tumor measurements for non-renal tumors were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) before and after treatment. Tumor measurements for non-renal tumors were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) before and after treatment. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest um LD recorded since treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre treatment, 4 hours after first treatment, and after one cycle of treatment (one cycle = 28 days)Population: This analysis was intended to be exploratory. Several other studies established that therapy with VEGFR agents modulated serum/plasma VEGF and soluble VEGFR2 levels, but there was no consistent \& established correlation with clinical outcome. These analyses were unlikely to add further to our ability to evaluate the major objectives of the study.
5-10cc venous blood was collected for evaluation of basal plasma levels of angiogenesis biomarkers VEGF and VEGFR-2.
Outcome measures
Outcome data not reported
Adverse Events
Vandetanib in Participants With Kidney Cancer
Serious adverse events
| Measure |
Vandetanib in Participants With Kidney Cancer
n=37 participants at risk
300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
|
|---|---|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
2.7%
1/37 • Number of events 3 • 72 months and 14 days
|
|
General disorders
Constitutional Symptoms - Other (Specify, generalized weakness)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
General disorders
Pain - Other (Specify, jaw pain and L shoulder pain)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Respiratory, thoracic and mediastinal disorders
Pain::Chest wall
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other, bronchitis; viral pneumonia
|
2.7%
1/37 • Number of events 2 • 72 months and 14 days
|
|
Eye disorders
Retinal detachment
|
2.7%
1/37 • Number of events 2 • 72 months and 14 days
|
|
General disorders
Rigors/chills
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Nervous system disorders
Syncope (fainting)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
Other adverse events
| Measure |
Vandetanib in Participants With Kidney Cancer
n=37 participants at risk
300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
81.1%
30/37 • Number of events 48 • 72 months and 14 days
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, hematuria)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Musculoskeletal and connective tissue disorders
Seroma
|
2.7%
1/37 • Number of events 2 • 72 months and 14 days
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
5.4%
2/37 • Number of events 2 • 72 months and 14 days
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
37.8%
14/37 • Number of events 25 • 72 months and 14 days
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Sinus bradycardia
|
2.7%
1/37 • Number of events 2 • 72 months and 14 days
|
|
General disorders
Sweating (diaphoresis)
|
8.1%
3/37 • Number of events 3 • 72 months and 14 days
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
64.9%
24/37 • Number of events 75 • 72 months and 14 days
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
45.9%
17/37 • Number of events 37 • 72 months and 14 days
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
45.9%
17/37 • Number of events 33 • 72 months and 14 days
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
35.1%
13/37 • Number of events 26 • 72 months and 14 days
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
8.1%
3/37 • Number of events 3 • 72 months and 14 days
|
|
Gastrointestinal disorders
Anorexia
|
5.4%
2/37 • Number of events 2 • 72 months and 14 days
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
16.2%
6/37 • Number of events 6 • 72 months and 14 days
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
13.5%
5/37 • Number of events 8 • 72 months and 14 days
|
|
Metabolism and nutrition disorders
CPK (creatine phosphokinase)
|
40.5%
15/37 • Number of events 31 • 72 months and 14 days
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
16.2%
6/37 • Number of events 9 • 72 months and 14 days
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
18.9%
7/37 • Number of events 14 • 72 months and 14 days
|
|
Cardiac disorders
Cardiac Arrhythmia - Other (Specify, __)
|
2.7%
1/37 • Number of events 2 • 72 months and 14 days
|
|
Hepatobiliary disorders
Cholecystitis
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Gastrointestinal disorders
Constipation
|
8.1%
3/37 • Number of events 3 • 72 months and 14 days
|
|
General disorders
Constitutional Symptoms - Other (Specify, extreme hunger and jitterness)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.2%
6/37 • Number of events 7 • 72 months and 14 days
|
|
Metabolism and nutrition disorders
Creatinine
|
70.3%
26/37 • Number of events 70 • 72 months and 14 days
|
|
Renal and urinary disorders
Cystitis
|
5.4%
2/37 • Number of events 2 • 72 months and 14 days
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Gastrointestinal disorders
Diarrhea
|
64.9%
24/37 • Number of events 36 • 72 months and 14 days
|
|
Nervous system disorders
Dizziness
|
13.5%
5/37 • Number of events 7 • 72 months and 14 days
|
|
Eye disorders
Dry eye syndrome
|
13.5%
5/37 • Number of events 6 • 72 months and 14 days
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
8.1%
3/37 • Number of events 3 • 72 months and 14 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.5%
5/37 • Number of events 5 • 72 months and 14 days
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Blood and lymphatic system disorders
Edema: limb
|
5.4%
2/37 • Number of events 3 • 72 months and 14 days
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
5.4%
2/37 • Number of events 2 • 72 months and 14 days
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
43.2%
16/37 • Number of events 21 • 72 months and 14 days
|
|
Gastrointestinal disorders
Flatulence
|
8.1%
3/37 • Number of events 3 • 72 months and 14 days
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
54.1%
20/37 • Number of events 56 • 72 months and 14 days
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
37.8%
14/37 • Number of events 29 • 72 months and 14 days
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
8.1%
3/37 • Number of events 4 • 72 months and 14 days
|
|
Blood and lymphatic system disorders
Hemoglobin
|
13.5%
5/37 • Number of events 10 • 72 months and 14 days
|
|
Metabolism and nutrition disorders
Hemoglobinuria
|
29.7%
11/37 • Number of events 18 • 72 months and 14 days
|
|
Renal and urinary disorders
Hemorrhage, GU::Bladder
|
16.2%
6/37 • Number of events 8 • 72 months and 14 days
|
|
Renal and urinary disorders
Hemorrhage, GU::Urinary NOS
|
13.5%
5/37 • Number of events 5 • 72 months and 14 days
|
|
Reproductive system and breast disorders
Hemorrhage, GU::Vagina
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory::Nose
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Renal and urinary disorders
Hemorrhage/Bleeding - Other (Specify, hematuria)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Endocrine disorders
Hot flashes/flushes
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
5.4%
2/37 • Number of events 2 • 72 months and 14 days
|
|
Cardiac disorders
Hypertension
|
24.3%
9/37 • Number of events 13 • 72 months and 14 days
|
|
Cardiac disorders
Hypotension
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Renal and urinary disorders
Incontinence, urinary
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Infections and infestations
Infection - Other (Specify, bladder infection)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Dental-tooth
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
General disorders
Insomnia
|
29.7%
11/37 • Number of events 16 • 72 months and 14 days
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
8.1%
3/37 • Number of events 4 • 72 months and 14 days
|
|
Blood and lymphatic system disorders
Lymphopenia
|
45.9%
17/37 • Number of events 28 • 72 months and 14 days
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
24.3%
9/37 • Number of events 10 • 72 months and 14 days
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
43.2%
16/37 • Number of events 37 • 72 months and 14 days
|
|
Gastrointestinal disorders
Malabsorption
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Nervous system disorders
Mood alteration::Agitation
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Nervous system disorders
Mood alteration::Anxiety
|
24.3%
9/37 • Number of events 12 • 72 months and 14 days
|
|
Nervous system disorders
Mood alteration::Depression
|
16.2%
6/37 • Number of events 6 • 72 months and 14 days
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)::Oral cavity
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, crushed thumb)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Gastrointestinal disorders
Nausea
|
43.2%
16/37 • Number of events 24 • 72 months and 14 days
|
|
Nervous system disorders
Neurology - Other (Specify, R lower extremity foot weakness)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Nervous system disorders
Neuropathy: sensory
|
5.4%
2/37 • Number of events 2 • 72 months and 14 days
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
5.4%
2/37 • Number of events 3 • 72 months and 14 days
|
|
Eye disorders
Ocular surface disease
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Eye disorders
Ocular/Visual - Other (Specify, corneal epithelial defect)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Ear and labyrinth disorders
Otitis, external ear (non-infectious)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
General disorders
Pain - Other (Specify, bilateral ankle pain)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Gastrointestinal disorders
Pain::Abdomen NOS
|
5.4%
2/37 • Number of events 4 • 72 months and 14 days
|
|
Musculoskeletal and connective tissue disorders
Pain::Back
|
5.4%
2/37 • Number of events 3 • 72 months and 14 days
|
|
Gastrointestinal disorders
Pain::Dental/teeth/peridontal
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Nervous system disorders
Pain::Head/headache
|
8.1%
3/37 • Number of events 4 • 72 months and 14 days
|
|
Musculoskeletal and connective tissue disorders
Pain::Joint
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Musculoskeletal and connective tissue disorders
Pain::Muscle
|
2.7%
1/37 • Number of events 3 • 72 months and 14 days
|
|
Skin and subcutaneous tissue disorders
Pain::Oral-gums
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Reproductive system and breast disorders
Pain::Pelvis
|
5.4%
2/37 • Number of events 2 • 72 months and 14 days
|
|
Cardiac disorders
Palpitations
|
5.4%
2/37 • Number of events 2 • 72 months and 14 days
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
40.5%
15/37 • Number of events 29 • 72 months and 14 days
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
5.4%
2/37 • Number of events 2 • 72 months and 14 days
|
|
Blood and lymphatic system disorders
Platelets
|
10.8%
4/37 • Number of events 9 • 72 months and 14 days
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
29.7%
11/37 • Number of events 19 • 72 months and 14 days
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
16.2%
6/37 • Number of events 7 • 72 months and 14 days
|
|
Cardiac disorders
Prolonged QTc interval
|
64.9%
24/37 • Number of events 119 • 72 months and 14 days
|
|
Metabolism and nutrition disorders
Proteinuria
|
56.8%
21/37 • Number of events 44 • 72 months and 14 days
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
2.7%
1/37 • Number of events 3 • 72 months and 14 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, asthma)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
10.8%
4/37 • Number of events 7 • 72 months and 14 days
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Nervous system disorders
Tremor
|
5.4%
2/37 • Number of events 2 • 72 months and 14 days
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
5.4%
2/37 • Number of events 2 • 72 months and 14 days
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
35.1%
13/37 • Number of events 32 • 72 months and 14 days
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
5.4%
2/37 • Number of events 4 • 72 months and 14 days
|
|
Eye disorders
Vision-blurred vision
|
5.4%
2/37 • Number of events 2 • 72 months and 14 days
|
|
Eye disorders
Vision-flashing lights/floaters
|
5.4%
2/37 • Number of events 2 • 72 months and 14 days
|
|
Gastrointestinal disorders
Vomiting
|
16.2%
6/37 • Number of events 8 • 72 months and 14 days
|
|
General disorders
Weight gain
|
5.4%
2/37 • Number of events 3 • 72 months and 14 days
|
|
General disorders
Weight loss
|
24.3%
9/37 • Number of events 14 • 72 months and 14 days
|
|
Cardiac disorders
Cardiac arrhythmia-Other, Specify (tachycardia)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, dry scalp)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify,dry, chapped lips)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify,eczematous dermatitis
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, erythema L leg)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, erythema on face)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, paronychia of L great toe)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Infections and infestations
Infection - Other (Specify, bladder (urinary)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Infections and infestations
Infection - Other (Specify, sinusitis)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Infections and infestations
Infection - Other (Specify, tooth abscess)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Infections and infestations
Infection - Other (Specify, sinus infection)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Eye disorders
Ocular/Visual - Other (Specify, corneal verticillata)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Eye disorders
Ocular/Visual - Other (Specify, halos at night)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Eye disorders
Ocular/Visual - Other (Specify, ocular/visual other-vortex keratopathy)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
General disorders
Pain - Other (Specify, cramp in extremities)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
General disorders
Pain - Other (Specify, dysuria)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
General disorders
Pain - Other (Specify, intermittent chest/thorax)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
General disorders
Pain - Other (Specify, left elbow)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
General disorders
Pain - Other (Specify, myalgia)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
General disorders
Pain - Other (Specify, pain bilateral feet)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
General disorders
Pain - Other (Specify, pain under R ribcage)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
General disorders
Pain - Other (Specify, pain-L elbow pain)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
General disorders
Pain - Other (Specify, pain-R ankle pain)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
General disorders
Pain - Other (Specify, R shoulder)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
General disorders
Pain - Other (Specify, suprapubic)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
General disorders
Pain - Other (Specify, tooth sensitivity)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, bronchitis)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, cold)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, cold symptoms)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, congestion)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, upper respiratory infection)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, LUTS Syndrome - decreased urinary flow)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, microscopic hematuria)
|
2.7%
1/37 • Number of events 1 • 72 months and 14 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place