Trial Outcomes & Findings for Sunitinib Malate in Treating Patients With Thyroid Cancer That Did Not Respond to Iodine I 131 and Cannot Be Removed by Surgery (NCT NCT00381641)
NCT ID: NCT00381641
Last Updated: 2025-03-28
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2025-03-28
Participant Flow
Participant milestones
| Measure |
Sunitinib Malate-Radioactive Iodine Refractory Subgroup
Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
This arm contains results for the Radioactive Iodine Refractory Thyroid Cancer Subgroup
Sunitinib Malate: Given PO
|
Sunitinib Malate-Metastatic Medullary Subgroup
Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
This arm contains results for the Metastatic Medullary Thyroid Cancer Subgroup
Sunitinib Malate: Given PO
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
25
|
|
Overall Study
COMPLETED
|
38
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Sunitinib Malate-Radioactive Iodine Refractory Subgroup
Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
This arm contains results for the Radioactive Iodine Refractory Thyroid Cancer Subgroup
Sunitinib Malate: Given PO
|
Sunitinib Malate-Metastatic Medullary Subgroup
Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
This arm contains results for the Metastatic Medullary Thyroid Cancer Subgroup
Sunitinib Malate: Given PO
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Sunitinib Malate in Treating Patients With Thyroid Cancer That Did Not Respond to Iodine I 131 and Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Sunitinib Malate-Radioactive Iodine Refractory Subgroup
n=38 Participants
Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
This arm contains results for the Radioactive Iodine Refractory Thyroid Cancer Subgroup
Sunitinib Malate: Given PO
|
Sunitinib Malate-Metastatic Medullary Subgroup
n=25 Participants
Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
This arm contains results for the Metastatic Medullary Thyroid Cancer Subgroup
Sunitinib Malate: Given PO
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.1 years
n=5 Participants
|
50.9 years
n=7 Participants
|
55.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
25 participants
n=7 Participants
|
63 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."
Outcome measures
| Measure |
Sunitinib Malate-Radioactive Iodine Refractory Subgroup
n=38 Participants
Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
This arm contains results for the Radioactive Iodine Refractory Thyroid Cancer Subgroup
Sunitinib Malate: Given PO
|
Sunitinib Malate-Metastatic Medullary Subgroup
n=25 Participants
Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
This arm contains results for the Metastatic Medullary Thyroid Cancer Subgroup
Sunitinib Malate: Given PO
|
|---|---|---|
|
Objective Response Rate, Assessed Using the Response Evaluation Criteria in Solid Tumors (RECIST)
|
9 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: From time of first treatment with sunitinib, assessed up to 2 yearsAny grade toxicity of any type, regardless of attribution
Outcome measures
| Measure |
Sunitinib Malate-Radioactive Iodine Refractory Subgroup
n=38 Participants
Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
This arm contains results for the Radioactive Iodine Refractory Thyroid Cancer Subgroup
Sunitinib Malate: Given PO
|
Sunitinib Malate-Metastatic Medullary Subgroup
n=25 Participants
Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
This arm contains results for the Metastatic Medullary Thyroid Cancer Subgroup
Sunitinib Malate: Given PO
|
|---|---|---|
|
Incidence of Toxicity, Graded According to the Common Terminology Criteria for Adverse Events Version 3.0
|
38 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Up to 10 yearsKaplan-Meier curves will be generated and 95% confidence intervals will be derived for median overall survival.
Outcome measures
| Measure |
Sunitinib Malate-Radioactive Iodine Refractory Subgroup
n=38 Participants
Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
This arm contains results for the Radioactive Iodine Refractory Thyroid Cancer Subgroup
Sunitinib Malate: Given PO
|
Sunitinib Malate-Metastatic Medullary Subgroup
n=25 Participants
Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
This arm contains results for the Metastatic Medullary Thyroid Cancer Subgroup
Sunitinib Malate: Given PO
|
|---|---|---|
|
Overall Survival
|
32.6 Months
Interval 18.4 to 70.9
|
65.4 Months
Interval 27.0 to 69.5
|
SECONDARY outcome
Timeframe: Time from start of treatment to time of progression or death of any cause, assessed up to 10 yearsOutcome measures
| Measure |
Sunitinib Malate-Radioactive Iodine Refractory Subgroup
n=38 Participants
Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
This arm contains results for the Radioactive Iodine Refractory Thyroid Cancer Subgroup
Sunitinib Malate: Given PO
|
Sunitinib Malate-Metastatic Medullary Subgroup
n=25 Participants
Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
This arm contains results for the Metastatic Medullary Thyroid Cancer Subgroup
Sunitinib Malate: Given PO
|
|---|---|---|
|
Time to Progression or Death Evaluated Using the RECIST
|
12.8 Months
Interval 8.3 to 16.4
|
19.3 Months
Interval 7.7 to 34.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 2 yearsRelevant laboratory correlates will be compared between responders and non-responders using the Wilcoxon rank sum test. The association between the presence or absence of RET gene rearrangements/mutations and tumor response, as well as the association between germ-line polymorphisms in the RET gene and response, will be analyzed using Fisher's exact test. The correlative and genetic data will also be entered as covariates (univariate analyses only due to the small sample size) in a Cox regression model of progression-free survival.
Outcome measures
Outcome data not reported
Adverse Events
Sunitinib Malate-Radioactive Iodine Refractory Subgroup
Serious events: 17 serious events
Other events: 38 other events
Deaths: 21 deaths
Sunitinib Malate-Metastatic Medullary Subgroup
Serious events: 12 serious events
Other events: 24 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Sunitinib Malate-Radioactive Iodine Refractory Subgroup
n=38 participants at risk
Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
This arm contains results for the Radioactive Iodine Refractory Thyroid Cancer Subgroup
Sunitinib Malate: Given PO
|
Sunitinib Malate-Metastatic Medullary Subgroup
n=25 participants at risk
Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
This arm contains results for the Metastatic Medullary Thyroid Cancer Subgroup
Sunitinib Malate: Given PO
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/38
|
8.0%
2/25
|
|
Renal and urinary disorders
Acute kidney injury
|
2.6%
1/38
|
0.00%
0/25
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/38
|
8.0%
2/25
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/38
|
4.0%
1/25
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/38
|
4.0%
1/25
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/38
|
4.0%
1/25
|
|
Cardiac disorders
Cardiac disorders - Other
|
2.6%
1/38
|
0.00%
0/25
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/38
|
4.0%
1/25
|
|
General disorders
Death NOS
|
2.6%
1/38
|
0.00%
0/25
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
2/38
|
4.0%
1/25
|
|
Gastrointestinal disorders
Dysphagia
|
2.6%
1/38
|
4.0%
1/25
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/38
|
8.0%
2/25
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.6%
1/38
|
4.0%
1/25
|
|
General disorders
Fatigue
|
2.6%
1/38
|
0.00%
0/25
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
2.6%
1/38
|
0.00%
0/25
|
|
Gastrointestinal disorders
Gastric ulcer
|
2.6%
1/38
|
0.00%
0/25
|
|
Gastrointestinal disorders
Gastritis
|
2.6%
1/38
|
0.00%
0/25
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
0.00%
0/38
|
4.0%
1/25
|
|
Hepatobiliary disorders
Hepatic failure
|
5.3%
2/38
|
0.00%
0/25
|
|
Vascular disorders
Hypertension
|
2.6%
1/38
|
0.00%
0/25
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.6%
1/38
|
0.00%
0/25
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/38
|
4.0%
1/25
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
2.6%
1/38
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal obstruction
|
0.00%
0/38
|
4.0%
1/25
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
5.3%
2/38
|
0.00%
0/25
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/38
|
4.0%
1/25
|
|
Investigations
Neutrophil count decreased
|
2.6%
1/38
|
0.00%
0/25
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/38
|
4.0%
1/25
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/38
|
4.0%
1/25
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/38
|
4.0%
1/25
|
|
Investigations
Platelet count decreased
|
2.6%
1/38
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.6%
1/38
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.3%
2/38
|
8.0%
2/25
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/38
|
4.0%
1/25
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
0.00%
0/38
|
4.0%
1/25
|
|
Infections and infestations
Skin infection
|
2.6%
1/38
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/38
|
4.0%
1/25
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/38
|
4.0%
1/25
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal fistula
|
2.6%
1/38
|
0.00%
0/25
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/38
|
0.00%
0/25
|
Other adverse events
| Measure |
Sunitinib Malate-Radioactive Iodine Refractory Subgroup
n=38 participants at risk
Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
This arm contains results for the Radioactive Iodine Refractory Thyroid Cancer Subgroup
Sunitinib Malate: Given PO
|
Sunitinib Malate-Metastatic Medullary Subgroup
n=25 participants at risk
Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
This arm contains results for the Metastatic Medullary Thyroid Cancer Subgroup
Sunitinib Malate: Given PO
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.5%
4/38
|
20.0%
5/25
|
|
Investigations
Alanine aminotransferase increased
|
36.8%
14/38
|
24.0%
6/25
|
|
Investigations
Alkaline phosphatase increased
|
21.1%
8/38
|
16.0%
4/25
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
10.5%
4/38
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.9%
3/38
|
28.0%
7/25
|
|
Blood and lymphatic system disorders
Anemia
|
76.3%
29/38
|
56.0%
14/25
|
|
Metabolism and nutrition disorders
Anorexia
|
34.2%
13/38
|
36.0%
9/25
|
|
Psychiatric disorders
Anxiety
|
7.9%
3/38
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.5%
4/38
|
16.0%
4/25
|
|
Investigations
Aspartate aminotransferase increased
|
42.1%
16/38
|
16.0%
4/25
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.5%
4/38
|
24.0%
6/25
|
|
Investigations
Blood bilirubin increased
|
7.9%
3/38
|
16.0%
4/25
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.9%
3/38
|
0.00%
0/25
|
|
Infections and infestations
Bronchial infection
|
5.3%
2/38
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
5.3%
2/38
|
0.00%
0/25
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/38
|
8.0%
2/25
|
|
Gastrointestinal disorders
Constipation
|
34.2%
13/38
|
16.0%
4/25
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.3%
10/38
|
16.0%
4/25
|
|
Investigations
Creatinine increased
|
15.8%
6/38
|
4.0%
1/25
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
2/38
|
4.0%
1/25
|
|
Gastrointestinal disorders
Diarrhea
|
65.8%
25/38
|
44.0%
11/25
|
|
Nervous system disorders
Dizziness
|
13.2%
5/38
|
16.0%
4/25
|
|
Gastrointestinal disorders
Dry mouth
|
13.2%
5/38
|
8.0%
2/25
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.2%
5/38
|
4.0%
1/25
|
|
Nervous system disorders
Dysgeusia
|
26.3%
10/38
|
24.0%
6/25
|
|
Gastrointestinal disorders
Dyspepsia
|
36.8%
14/38
|
4.0%
1/25
|
|
Gastrointestinal disorders
Dysphagia
|
5.3%
2/38
|
4.0%
1/25
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.4%
7/38
|
12.0%
3/25
|
|
General disorders
Edema face
|
5.3%
2/38
|
32.0%
8/25
|
|
General disorders
Edema limbs
|
10.5%
4/38
|
16.0%
4/25
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
21.1%
8/38
|
16.0%
4/25
|
|
Eye disorders
Eye disorders - Other
|
0.00%
0/38
|
8.0%
2/25
|
|
General disorders
Fatigue
|
86.8%
33/38
|
72.0%
18/25
|
|
General disorders
Fever
|
15.8%
6/38
|
8.0%
2/25
|
|
Gastrointestinal disorders
Flatulence
|
5.3%
2/38
|
4.0%
1/25
|
|
Gastrointestinal disorders
Gastritis
|
7.9%
3/38
|
8.0%
2/25
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
5.3%
2/38
|
8.0%
2/25
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.6%
1/38
|
12.0%
3/25
|
|
Nervous system disorders
Headache
|
23.7%
9/38
|
24.0%
6/25
|
|
Vascular disorders
Hot flashes
|
7.9%
3/38
|
0.00%
0/25
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
71.1%
27/38
|
68.0%
17/25
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.3%
2/38
|
4.0%
1/25
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.6%
1/38
|
12.0%
3/25
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.3%
2/38
|
8.0%
2/25
|
|
Vascular disorders
Hypertension
|
47.4%
18/38
|
16.0%
4/25
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/38
|
16.0%
4/25
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
26.3%
10/38
|
12.0%
3/25
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
31.6%
12/38
|
40.0%
10/25
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
10.5%
4/38
|
4.0%
1/25
|
|
Metabolism and nutrition disorders
Hypokalemia
|
18.4%
7/38
|
16.0%
4/25
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.5%
4/38
|
12.0%
3/25
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
15.8%
6/38
|
16.0%
4/25
|
|
Vascular disorders
Hypotension
|
5.3%
2/38
|
0.00%
0/25
|
|
Endocrine disorders
Hypothyroidism
|
2.6%
1/38
|
16.0%
4/25
|
|
Psychiatric disorders
Insomnia
|
10.5%
4/38
|
4.0%
1/25
|
|
Investigations
Investigations - Other
|
0.00%
0/38
|
24.0%
6/25
|
|
Investigations
Lipase increased
|
0.00%
0/38
|
12.0%
3/25
|
|
Infections and infestations
Lung infection
|
5.3%
2/38
|
4.0%
1/25
|
|
Investigations
Lymphocyte count decreased
|
52.6%
20/38
|
56.0%
14/25
|
|
Gastrointestinal disorders
Mucositis oral
|
47.4%
18/38
|
48.0%
12/25
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
2/38
|
12.0%
3/25
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
2.6%
1/38
|
8.0%
2/25
|
|
Gastrointestinal disorders
Nausea
|
52.6%
20/38
|
52.0%
13/25
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.9%
3/38
|
0.00%
0/25
|
|
Investigations
Neutrophil count decreased
|
55.3%
21/38
|
32.0%
8/25
|
|
General disorders
Non-cardiac chest pain
|
7.9%
3/38
|
8.0%
2/25
|
|
Gastrointestinal disorders
Oral pain
|
13.2%
5/38
|
8.0%
2/25
|
|
General disorders
Pain
|
7.9%
3/38
|
44.0%
11/25
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
23.7%
9/38
|
24.0%
6/25
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
47.4%
18/38
|
48.0%
12/25
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
18.4%
7/38
|
12.0%
3/25
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
13.2%
5/38
|
0.00%
0/25
|
|
Investigations
Platelet count decreased
|
57.9%
22/38
|
48.0%
12/25
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
21.1%
8/38
|
28.0%
7/25
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.6%
1/38
|
8.0%
2/25
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
5.3%
2/38
|
0.00%
0/25
|
|
Investigations
Serum amylase increased
|
0.00%
0/38
|
12.0%
3/25
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
5.3%
2/38
|
0.00%
0/25
|
|
Infections and infestations
Sinusitis
|
10.5%
4/38
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
2.6%
1/38
|
16.0%
4/25
|
|
Infections and infestations
Skin infection
|
5.3%
2/38
|
4.0%
1/25
|
|
Gastrointestinal disorders
Toothache
|
5.3%
2/38
|
0.00%
0/25
|
|
Infections and infestations
Upper respiratory infection
|
7.9%
3/38
|
0.00%
0/25
|
|
Infections and infestations
Urinary tract infection
|
5.3%
2/38
|
0.00%
0/25
|
|
Vascular disorders
Vascular disorders - Other
|
0.00%
0/38
|
8.0%
2/25
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
5.3%
2/38
|
0.00%
0/25
|
|
Gastrointestinal disorders
Vomiting
|
36.8%
14/38
|
12.0%
3/25
|
|
Investigations
Weight loss
|
7.9%
3/38
|
12.0%
3/25
|
|
Investigations
White blood cell decreased
|
78.9%
30/38
|
76.0%
19/25
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60