Trial Outcomes & Findings for Trial of Maintenance SUO11248 Versus Placebo Post Chemotherapy for Patients With Advanced Urothelial Carcinoma (NCT NCT00393796)
NCT ID: NCT00393796
Last Updated: 2014-11-13
Results Overview
The primary endpoint of this unblinded, randomized trial is to compare the 6-month progression rate in patients randomized to maintenance SU011248 as compared with placebo following primary chemotherapy. Progression is defined as a 20% increase in the sum of the longest diameter (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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
6 Months Post Treatment
Results posted on
2014-11-13
Participant Flow
Participants were originally randomized to SUTENT or Placebo (Double Blind Period). 26 participants were randomized to SUTENT. Of the 28 participants randomized to Placebo, those that progressed were offered SUTENT if they were eligible.
Participant milestones
| Measure |
SUTENT
Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
|
Placebo
Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
|
|---|---|---|
|
Double Blind Period
STARTED
|
26
|
28
|
|
Double Blind Period
COMPLETED
|
26
|
28
|
|
Double Blind Period
NOT COMPLETED
|
0
|
0
|
|
Open Label Period - Placebo to SUTENT
STARTED
|
0
|
16
|
|
Open Label Period - Placebo to SUTENT
COMPLETED
|
0
|
16
|
|
Open Label Period - Placebo to SUTENT
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Maintenance SUO11248 Versus Placebo Post Chemotherapy for Patients With Advanced Urothelial Carcinoma
Baseline characteristics by cohort
| Measure |
SUTENT
n=26 Participants
Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
|
Placebo
n=28 Participants
Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69 years
n=93 Participants
|
69 years
n=4 Participants
|
69 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
ECOG Performance Status
PS=0
|
10 participants
n=93 Participants
|
11 participants
n=4 Participants
|
21 participants
n=27 Participants
|
|
ECOG Performance Status
PS=1
|
15 participants
n=93 Participants
|
17 participants
n=4 Participants
|
32 participants
n=27 Participants
|
|
ECOG Performance Status
PS=2
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Visceral Metastasis
|
9 participants
n=93 Participants
|
12 participants
n=4 Participants
|
21 participants
n=27 Participants
|
|
Bladder Primary Tumor
|
20 participants
n=93 Participants
|
18 participants
n=4 Participants
|
38 participants
n=27 Participants
|
|
Mixed Histology
|
2 participants
n=93 Participants
|
4 participants
n=4 Participants
|
6 participants
n=27 Participants
|
|
Prior Chemotherapy Regimen
Cisplatin and gemcitabine
|
10 participants
n=93 Participants
|
14 participants
n=4 Participants
|
24 participants
n=27 Participants
|
|
Prior Chemotherapy Regimen
MVAC
|
3 participants
n=93 Participants
|
2 participants
n=4 Participants
|
5 participants
n=27 Participants
|
|
Prior Chemotherapy Regimen
Non-cisplatin-containing chemotherapy
|
13 participants
n=93 Participants
|
12 participants
n=4 Participants
|
25 participants
n=27 Participants
|
|
Response to Prior Chemotherapy
CR
|
3 participants
n=93 Participants
|
1 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Response to Prior Chemotherapy
PR
|
10 participants
n=93 Participants
|
12 participants
n=4 Participants
|
22 participants
n=27 Participants
|
|
Response to Prior Chemotherapy
SD
|
13 participants
n=93 Participants
|
15 participants
n=4 Participants
|
28 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 Months Post TreatmentThe primary endpoint of this unblinded, randomized trial is to compare the 6-month progression rate in patients randomized to maintenance SU011248 as compared with placebo following primary chemotherapy. Progression is defined as a 20% increase in the sum of the longest diameter (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.
Outcome measures
| Measure |
SUTENT
n=26 Participants
Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
|
Placebo
n=28 Participants
Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
|
|---|---|---|
|
Percentage of Participants That Experience Progression by 6 Months for Participants Receiving Sunitinib and Participants Receiving Placebo
|
71.7 percentage of participants
Interval 54.0 to 87.0
|
64.3 percentage of participants
Interval 47.0 to 81.0
|
Adverse Events
SUTENT
Serious events: 17 serious events
Other events: 42 other events
Deaths: 0 deaths
Placebo Only
Serious events: 6 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SUTENT
n=42 participants at risk
Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
26 participants were randomized to SUTENT and 16 participants randomized to Placebo crossed over to SUTENT during treatment so a total of 42 participants were treated with SUTENT.
|
Placebo Only
n=28 participants at risk
Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
28 participants were randomized to Placebo. 16 of these 28 patients later received SUTENT.
|
|---|---|---|
|
Cardiac disorders
Cardiac General - Other
|
2.4%
1/42
|
3.6%
1/28
|
|
Gastrointestinal disorders
Constipation
|
2.4%
1/42
|
0.00%
0/28
|
|
General disorders
Death not associated with CTCAE term
|
11.9%
5/42
|
10.7%
3/28
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
1/42
|
0.00%
0/28
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
4.8%
2/42
|
3.6%
1/28
|
|
Blood and lymphatic system disorders
Hemoglobin
|
4.8%
2/42
|
3.6%
1/28
|
|
Vascular disorders
Hemorrhage, GI
|
2.4%
1/42
|
3.6%
1/28
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils
|
4.8%
2/42
|
3.6%
1/28
|
|
Infections and infestations
Infection with unknown ANC
|
2.4%
1/42
|
3.6%
1/28
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
2.4%
1/42
|
3.6%
1/28
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/42
|
3.6%
1/28
|
|
Gastrointestinal disorders
Obstruction, GI
|
2.4%
1/42
|
0.00%
0/28
|
|
General disorders
Pain
|
2.4%
1/42
|
7.1%
2/28
|
|
Blood and lymphatic system disorders
Platelets
|
4.8%
2/42
|
3.6%
1/28
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
2.4%
1/42
|
0.00%
0/28
|
|
Psychiatric disorders
Psychosis (hallucinations/delusions)
|
2.4%
1/42
|
3.6%
1/28
|
|
Renal and urinary disorders
Renal failure
|
2.4%
1/42
|
3.6%
1/28
|
|
Nervous system disorders
Syncope (fainting)
|
2.4%
1/42
|
3.6%
1/28
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
2.4%
1/42
|
3.6%
1/28
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
2.4%
1/42
|
3.6%
1/28
|
|
Vascular disorders
CNS cerebrovascular ischemia
|
0.00%
0/42
|
3.6%
1/28
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
0.00%
0/42
|
3.6%
1/28
|
|
Renal and urinary disorders
Obstruction, GU
|
0.00%
0/42
|
3.6%
1/28
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/42
|
3.6%
1/28
|
Other adverse events
| Measure |
SUTENT
n=42 participants at risk
Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
26 participants were randomized to SUTENT and 16 participants randomized to Placebo crossed over to SUTENT during treatment so a total of 42 participants were treated with SUTENT.
|
Placebo Only
n=28 participants at risk
Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
28 participants were randomized to Placebo. 16 of these 28 patients later received SUTENT.
|
|---|---|---|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
14.3%
6/42
|
14.3%
4/28
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
26.2%
11/42
|
17.9%
5/28
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
11.9%
5/42
|
10.7%
3/28
|
|
Investigations
Alkaline phosphatase
|
9.5%
4/42
|
17.9%
5/28
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
4.8%
2/42
|
0.00%
0/28
|
|
Metabolism and nutrition disorders
Anorexia
|
47.6%
20/42
|
42.9%
12/28
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
7.1%
3/42
|
3.6%
1/28
|
|
Nervous system disorders
Ataxia (incoordination)
|
2.4%
1/42
|
3.6%
1/28
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other (Specify)
|
2.4%
1/42
|
3.6%
1/28
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
2.4%
1/42
|
3.6%
1/28
|
|
Injury, poisoning and procedural complications
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
2.4%
1/42
|
3.6%
1/28
|
|
Investigations
CD4 count
|
7.1%
3/42
|
3.6%
1/28
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
14.3%
6/42
|
14.3%
4/28
|
|
Cardiac disorders
Cardiac Arrhythmia - Other (Specify)
|
2.4%
1/42
|
3.6%
1/28
|
|
Cardiac disorders
Cardiac General - Other (Specify)
|
2.4%
1/42
|
3.6%
1/28
|
|
Gastrointestinal disorders
Colitis
|
2.4%
1/42
|
3.6%
1/28
|
|
Nervous system disorders
Confusion
|
4.8%
2/42
|
7.1%
2/28
|
|
Gastrointestinal disorders
Constipation
|
35.7%
15/42
|
39.3%
11/28
|
|
General disorders
Constitutional Symptoms - Other
|
11.9%
5/42
|
14.3%
4/28
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
12/42
|
32.1%
9/28
|
|
Investigations
Creatinine
|
35.7%
15/42
|
39.3%
11/28
|
|
Renal and urinary disorders
Cystitis
|
11.9%
5/42
|
10.7%
3/28
|
|
General disorders
Death not associated with CTCAE term
|
11.9%
5/42
|
10.7%
3/28
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
7/42
|
10.7%
3/28
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify)
|
21.4%
9/42
|
7.1%
2/28
|
|
Gastrointestinal disorders
Diarrhea
|
57.1%
24/42
|
42.9%
12/28
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
11.9%
5/42
|
10.7%
3/28
|
|
Nervous system disorders
Dizziness
|
16.7%
7/42
|
39.3%
11/28
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
9.5%
4/42
|
3.6%
1/28
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
21.4%
9/42
|
7.1%
2/28
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
2.4%
1/42
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
23.8%
10/42
|
21.4%
6/28
|
|
General disorders
Edema: head and neck
|
9.5%
4/42
|
7.1%
2/28
|
|
General disorders
Edema: limb
|
11.9%
5/42
|
21.4%
6/28
|
|
Endocrine disorders
Endocrine - Other
|
2.4%
1/42
|
0.00%
0/28
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.4%
1/42
|
3.6%
1/28
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
71.4%
30/42
|
82.1%
23/28
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <'1.0 x 10e9/L)
|
11.9%
5/42
|
10.7%
3/28
|
|
Gastrointestinal disorders
Flatulence
|
9.5%
4/42
|
3.6%
1/28
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
9.5%
4/42
|
3.6%
1/28
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
2.4%
1/42
|
3.6%
1/28
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
23.8%
10/42
|
39.3%
11/28
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
2.4%
1/42
|
3.6%
1/28
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
14.3%
6/42
|
17.9%
5/28
|
|
Ear and labyrinth disorders
Hearing: patients with/without baseline audiogram and enrolled in a monitoring program
|
2.4%
1/42
|
3.6%
1/28
|
|
Ear and labyrinth disorders
Hearing: patients without baseline audiogram and not enrolled in a monitoring program
|
4.8%
2/42
|
3.6%
1/28
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
7.1%
3/42
|
10.7%
3/28
|
|
Vascular disorders
Hematoma
|
2.4%
1/42
|
0.00%
0/28
|
|
Blood and lymphatic system disorders
Hemoglobin
|
42.9%
18/42
|
46.4%
13/28
|
|
Blood and lymphatic system disorders
Hemoglobinuria
|
2.4%
1/42
|
0.00%
0/28
|
|
Vascular disorders
Hemorrhage, GI
|
7.1%
3/42
|
7.1%
2/28
|
|
Vascular disorders
Hemorrhage, GU
|
21.4%
9/42
|
17.9%
5/28
|
|
Vascular disorders
Hemorrhage, pulmonary/upper respiratory
|
11.9%
5/42
|
3.6%
1/28
|
|
Vascular disorders
Hemorrhage/Bleeding - Other (Specify)
|
7.1%
3/42
|
7.1%
2/28
|
|
Gastrointestinal disorders
Hemorrhoids
|
7.1%
3/42
|
3.6%
1/28
|
|
Vascular disorders
Hot flashes/flushes
|
2.4%
1/42
|
0.00%
0/28
|
|
Investigations
Hyperbilirubinemia
|
2.4%
1/42
|
7.1%
2/28
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.1%
3/42
|
10.7%
3/28
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.4%
1/42
|
0.00%
0/28
|
|
Cardiac disorders
Hypertension
|
33.3%
14/42
|
35.7%
10/28
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.8%
2/42
|
3.6%
1/28
|
|
Cardiac disorders
Hypotension
|
4.8%
2/42
|
3.6%
1/28
|
|
Gastrointestinal disorders
Incontinence, anal
|
2.4%
1/42
|
0.00%
0/28
|
|
Renal and urinary disorders
Incontinence, urinary
|
4.8%
2/42
|
7.1%
2/28
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils
|
9.5%
4/42
|
14.3%
4/28
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
11.9%
5/42
|
10.7%
3/28
|
|
Infections and infestations
Infection with unknown ANC
|
7.1%
3/42
|
10.7%
3/28
|
|
General disorders
Injection site reaction/extravasation changes
|
2.4%
1/42
|
3.6%
1/28
|
|
Psychiatric disorders
Insomnia
|
7.1%
3/42
|
7.1%
2/28
|
|
Musculoskeletal and connective tissue disorders
Joint-function
|
2.4%
1/42
|
3.6%
1/28
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
2.4%
1/42
|
7.1%
2/28
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
31.0%
13/42
|
21.4%
6/28
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.5%
4/42
|
7.1%
2/28
|
|
Metabolism and nutrition disorders
Lipase
|
2.4%
1/42
|
0.00%
0/28
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
2.4%
1/42
|
0.00%
0/28
|
|
Vascular disorders
Lymphatics - Other
|
4.8%
2/42
|
0.00%
0/28
|
|
Blood and lymphatic system disorders
Lymphopenia
|
14.3%
6/42
|
10.7%
3/28
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
4.8%
2/42
|
3.6%
1/28
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
9.5%
4/42
|
3.6%
1/28
|
|
Nervous system disorders
Memory impairment
|
7.1%
3/42
|
10.7%
3/28
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other
|
7.1%
3/42
|
7.1%
2/28
|
|
Psychiatric disorders
Mood alteration
|
4.8%
2/42
|
3.6%
1/28
|
|
Investigations
Mucositis/stomatitis (clinical exam)
|
11.9%
5/42
|
0.00%
0/28
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
14.3%
6/42
|
3.6%
1/28
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
19.0%
8/42
|
17.9%
5/28
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
2.4%
1/42
|
0.00%
0/28
|
|
Gastrointestinal disorders
Nausea
|
40.5%
17/42
|
39.3%
11/28
|
|
Nervous system disorders
Neurology - Other
|
4.8%
2/42
|
7.1%
2/28
|
|
Nervous system disorders
Neuropathy: cranial
|
2.4%
1/42
|
0.00%
0/28
|
|
Nervous system disorders
Neuropathy: motor
|
9.5%
4/42
|
7.1%
2/28
|
|
Nervous system disorders
Neuropathy: sensory
|
31.0%
13/42
|
21.4%
6/28
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
14.3%
6/42
|
25.0%
7/28
|
|
Gastrointestinal disorders
Obstruction, GI
|
2.4%
1/42
|
3.6%
1/28
|
|
Respiratory, thoracic and mediastinal disorders
Obstruction/stenosis of airway
|
2.4%
1/42
|
0.00%
0/28
|
|
Investigations
PTT (Partial Thromboplastin Time)
|
4.8%
2/42
|
0.00%
0/28
|
|
General disorders
Pain
|
100.0%
42/42
|
100.0%
28/28
|
|
General disorders
Pain - Other
|
21.4%
9/42
|
28.6%
8/28
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
2.4%
1/42
|
0.00%
0/28
|
|
Blood and lymphatic system disorders
Platelets
|
57.1%
24/42
|
35.7%
10/28
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
9.5%
4/42
|
7.1%
2/28
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
4.8%
2/42
|
0.00%
0/28
|
|
Renal and urinary disorders
Proteinuria
|
4.8%
2/42
|
3.6%
1/28
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
9.5%
4/42
|
7.1%
2/28
|
|
Psychiatric disorders
Psychosis (hallucinations/delusions)
|
2.4%
1/42
|
3.6%
1/28
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify)
|
4.8%
2/42
|
7.1%
2/28
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
23.8%
10/42
|
21.4%
6/28
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
2.4%
1/42
|
0.00%
0/28
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
16.7%
7/42
|
10.7%
3/28
|
|
Renal and urinary disorders
Renal failure
|
4.8%
2/42
|
3.6%
1/28
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
7.1%
3/42
|
7.1%
2/28
|
|
General disorders
Rigors/chills
|
14.3%
6/42
|
14.3%
4/28
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
16.7%
7/42
|
10.7%
3/28
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
4.8%
2/42
|
0.00%
0/28
|
|
General disorders
Sweating (diaphoresis)
|
4.8%
2/42
|
3.6%
1/28
|
|
Nervous system disorders
Syncope (fainting)
|
7.1%
3/42
|
7.1%
2/28
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
31.0%
13/42
|
21.4%
6/28
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
2.4%
1/42
|
7.1%
2/28
|
|
Endocrine disorders
Thyroid function, high (hyperthyroidism, thyrotoxicosis)
|
2.4%
1/42
|
0.00%
0/28
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
14.3%
6/42
|
17.9%
5/28
|
|
Ear and labyrinth disorders
Tinnitus
|
2.4%
1/42
|
0.00%
0/28
|
|
Nervous system disorders
Tremor
|
4.8%
2/42
|
3.6%
1/28
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
7.1%
3/42
|
3.6%
1/28
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
2.4%
1/42
|
0.00%
0/28
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
9.5%
4/42
|
28.6%
8/28
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
2.4%
1/42
|
3.6%
1/28
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
2.4%
1/42
|
3.6%
1/28
|
|
Eye disorders
Vision-blurred vision
|
2.4%
1/42
|
0.00%
0/28
|
|
Vascular disorders
Vitreous hemorrhage
|
2.4%
1/42
|
0.00%
0/28
|
|
Gastrointestinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
9.5%
4/42
|
3.6%
1/28
|
|
Gastrointestinal disorders
Vomiting
|
26.2%
11/42
|
21.4%
6/28
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
4.8%
2/42
|
0.00%
0/28
|
|
General disorders
Weight loss
|
11.9%
5/42
|
7.1%
2/28
|
|
Vascular disorders
CNS cerebrovascular ischemia
|
0.00%
0/42
|
3.6%
1/28
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
0.00%
0/42
|
3.6%
1/28
|
|
Skin and subcutaneous tissue disorders
Dermal change lymphedema, phlebolymphedema
|
0.00%
0/42
|
3.6%
1/28
|
|
Blood and lymphatic system disorders
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
|
0.00%
0/42
|
3.6%
1/28
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
0.00%
0/42
|
3.6%
1/28
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/42
|
3.6%
1/28
|
|
Investigations
INR (International Normalized Ratio of prothrombin time)
|
0.00%
0/42
|
3.6%
1/28
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
0.00%
0/42
|
3.6%
1/28
|
|
Gastrointestinal disorders
Obstruction, GU
|
0.00%
0/42
|
3.6%
1/28
|
|
Infections and infestations
Pancreatitis
|
0.00%
0/42
|
3.6%
1/28
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.00%
0/42
|
3.6%
1/28
|
Additional Information
Dr. Maha Hussain, M.D.
University of Michigan Comprehensive Cancer Center
Phone: 1-800-865-1125
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place