Trial Outcomes & Findings for Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer (NCT NCT01835158)
NCT ID: NCT01835158
Last Updated: 2021-02-11
Results Overview
Progression free survival (PFS) was investigator assessed and is measured from the beginning of treatment until patient progression or death. Progression was determined using RECIST 1.1 criteria, progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).The primary analysis will be based on the stratified log-rank statistic to compare the two treatment arms on PFS. The Kaplan-Meier product-limit estimator will be used to estimate PFS distributions.Progression Free Survival was assessed per investigator, as this was the protocol-specified endpoint, and both investigator and independent review analyses of the PFS endpoint have been published
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
157 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2021-02-11
Participant Flow
Participant milestones
| Measure |
Arm I (Cabozantinib-s-malate)
Patients receive 60mg cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm II (Sunitinib Malate)
Patients receive 50mg sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
79
|
78
|
|
Overall Study
COMPLETED
|
78
|
72
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
Reasons for withdrawal
| Measure |
Arm I (Cabozantinib-s-malate)
Patients receive 60mg cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm II (Sunitinib Malate)
Patients receive 50mg sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
6
|
Baseline Characteristics
Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Cabozantinib-s-malate)
n=79 Participants
Patients receive 60mg cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm II (Sunitinib Malate)
n=78 Participants
Patients receive 50mg sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
64 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
70 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
145 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
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: All patients that were enrolled on to study.
Progression free survival (PFS) was investigator assessed and is measured from the beginning of treatment until patient progression or death. Progression was determined using RECIST 1.1 criteria, progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).The primary analysis will be based on the stratified log-rank statistic to compare the two treatment arms on PFS. The Kaplan-Meier product-limit estimator will be used to estimate PFS distributions.Progression Free Survival was assessed per investigator, as this was the protocol-specified endpoint, and both investigator and independent review analyses of the PFS endpoint have been published
Outcome measures
| Measure |
Arm I (Cabozantinib-s-malate)
n=79 Participants
Patients receive 60mg cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm II (Sunitinib Malate)
n=78 Participants
Patients receive 50mg sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
8.2 Months
Interval 6.2 to 8.8
|
5.6 Months
Interval 3.4 to 8.1
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: All enrolled patients
The primary analysis will be based on the stratified log-rank statistic to compare the two treatment arms on OS. The Kaplan-Meier product-limit estimator will be used to estimate OS distributions.
Outcome measures
| Measure |
Arm I (Cabozantinib-s-malate)
n=79 Participants
Patients receive 60mg cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm II (Sunitinib Malate)
n=78 Participants
Patients receive 50mg sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival (OS)
|
30.3 Months
Interval 14.6 to 35.0
|
21.8 Months
Interval 16.3 to 27.0
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All enrolled patients.
Objective response rates (ORR) was investigator assessed. ORR is the rate of complete or partial responses, based on RECIST 1.1 criteria. A response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. The Fisher exact test will be used to compare the two treatment arms.
Outcome measures
| Measure |
Arm I (Cabozantinib-s-malate)
n=79 Participants
Patients receive 60mg cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm II (Sunitinib Malate)
n=78 Participants
Patients receive 50mg sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Objective Response Rates
|
0.33 proportion of participants
Interval 0.23 to 0.44
|
0.12 proportion of participants
Interval 0.054 to 0.21
|
Adverse Events
Arm I (Cabozantinib-s-malate)
Serious events: 39 serious events
Other events: 76 other events
Deaths: 0 deaths
Arm II (Sunitinib Malate)
Serious events: 39 serious events
Other events: 68 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Cabozantinib-s-malate)
n=78 participants at risk
Patients receive cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm II (Sunitinib Malate)
n=72 participants at risk
Patients receive sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.6%
2/78 • Number of events 2
|
1.4%
1/72 • Number of events 1
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/78
|
2.8%
2/72 • Number of events 2
|
|
Cardiac disorders
Palpitations
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Endocrine disorders
Hyperthyroidism
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Gastrointestinal disorders
Colonic perforation
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
5.1%
4/78 • Number of events 4
|
6.9%
5/72 • Number of events 6
|
|
Gastrointestinal disorders
Esophageal pain
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
1.3%
1/78 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.3%
1/78 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
|
Gastrointestinal disorders
Jejunal perforation
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Gastrointestinal disorders
Mucositis oral
|
2.6%
2/78 • Number of events 3
|
1.4%
1/72 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
2.6%
2/78 • Number of events 2
|
5.6%
4/72 • Number of events 5
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
1/78 • Number of events 1
|
5.6%
4/72 • Number of events 5
|
|
General disorders
Death NOS
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
General disorders
Edema limbs
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
General disorders
Fatigue
|
1.3%
1/78 • Number of events 1
|
6.9%
5/72 • Number of events 6
|
|
General disorders
Fever
|
0.00%
0/78
|
2.8%
2/72 • Number of events 2
|
|
General disorders
Pain
|
2.6%
2/78 • Number of events 2
|
0.00%
0/72
|
|
Hepatobiliary disorders
Gallbladder pain
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Infections and infestations
Bladder infection
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Infections and infestations
Encephalitis infection
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Infections and infestations
Lung infection
|
2.6%
2/78 • Number of events 2
|
0.00%
0/72
|
|
Infections and infestations
Nail infection
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Infections and infestations
Sepsis
|
2.6%
2/78 • Number of events 2
|
1.4%
1/72 • Number of events 1
|
|
Infections and infestations
Skin infection
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Infections and infestations
Tooth infection
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Injury, poisoning and procedural complications
Fracture
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Investigations
Alanine aminotransferase increased
|
2.6%
2/78 • Number of events 3
|
2.8%
2/72 • Number of events 2
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
1.3%
1/78 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Investigations
Creatinine increased
|
2.6%
2/78 • Number of events 2
|
0.00%
0/72
|
|
Investigations
ECG QT corrected interval prolonged
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/78
|
2.8%
2/72 • Number of events 2
|
|
Investigations
Lipase increased
|
0.00%
0/78
|
2.8%
2/72 • Number of events 2
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/78
|
4.2%
3/72 • Number of events 3
|
|
Investigations
Platelet count decreased
|
0.00%
0/78
|
4.2%
3/72 • Number of events 3
|
|
Investigations
Serum amylase increased
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Investigations
Weight loss
|
3.8%
3/78 • Number of events 3
|
0.00%
0/72
|
|
Investigations
White blood cell decreased
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
2.6%
2/78 • Number of events 2
|
0.00%
0/72
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
3/78 • Number of events 3
|
2.8%
2/72 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.3%
1/78 • Number of events 1
|
1.4%
1/72 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.3%
1/78 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.6%
2/78 • Number of events 2
|
1.4%
1/72 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.6%
2/78 • Number of events 2
|
0.00%
0/72
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.3%
1/78 • Number of events 2
|
2.8%
2/72 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.8%
3/78 • Number of events 4
|
4.2%
3/72 • Number of events 3
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Metabolism and nutrition disorders
Arthralgia
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
2/78 • Number of events 2
|
0.00%
0/72
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.6%
2/78 • Number of events 2
|
1.4%
1/72 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Nervous system disorders
Dizziness
|
1.3%
1/78 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Nervous system disorders
Facial muscle weakness
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Nervous system disorders
Headache
|
0.00%
0/78
|
4.2%
3/72 • Number of events 3
|
|
Nervous system disorders
Hypoglossal nerve disorder
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Nervous system disorders
Intracranial hemorrhage
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
1.3%
1/78 • Number of events 1
|
2.8%
2/72 • Number of events 2
|
|
Nervous system disorders
Somnolence
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Nervous system disorders
Stroke
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Nervous system disorders
Syncope
|
3.8%
3/78 • Number of events 3
|
0.00%
0/72
|
|
Nervous system disorders
Transient ischemic attacks
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
1.3%
1/78 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
|
Psychiatric disorders
Depression
|
2.6%
2/78 • Number of events 2
|
0.00%
0/72
|
|
Renal and urinary disorders
Acute kidney injury
|
5.1%
4/78 • Number of events 4
|
2.8%
2/72 • Number of events 2
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.3%
1/78 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
1.3%
1/78 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/78
|
2.8%
2/72 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrm
|
5.1%
4/78 • Number of events 5
|
1.4%
1/72 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
2.6%
2/78 • Number of events 2
|
0.00%
0/72
|
|
Vascular disorders
Hypertension
|
10.3%
8/78 • Number of events 9
|
4.2%
3/72 • Number of events 3
|
|
Vascular disorders
Hypotension
|
3.8%
3/78 • Number of events 3
|
1.4%
1/72 • Number of events 1
|
|
Vascular disorders
Thromboembolic event
|
9.0%
7/78 • Number of events 7
|
1.4%
1/72 • Number of events 1
|
|
Vascular disorders
Vascular disorders - Other, specify
|
1.3%
1/78 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
|
Vascular disorders
Vasculitis
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
Other adverse events
| Measure |
Arm I (Cabozantinib-s-malate)
n=78 participants at risk
Patients receive cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm II (Sunitinib Malate)
n=72 participants at risk
Patients receive sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
37.2%
29/78 • Number of events 94
|
44.4%
32/72 • Number of events 103
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
2.6%
2/78 • Number of events 3
|
1.4%
1/72 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
1.3%
1/78 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
2.6%
2/78 • Number of events 7
|
0.00%
0/72
|
|
Cardiac disorders
Atrial flutter
|
1.3%
1/78 • Number of events 2
|
0.00%
0/72
|
|
Cardiac disorders
Heart failure
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Cardiac disorders
Palpitations
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Cardiac disorders
Sinus bradycardia
|
2.6%
2/78 • Number of events 3
|
2.8%
2/72 • Number of events 3
|
|
Cardiac disorders
Sinus tachycardia
|
1.3%
1/78 • Number of events 2
|
1.4%
1/72 • Number of events 1
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Oth spec
|
1.3%
1/78 • Number of events 2
|
0.00%
0/72
|
|
Ear and labyrinth disorders
Ear pain
|
1.3%
1/78 • Number of events 2
|
0.00%
0/72
|
|
Ear and labyrinth disorders
Hearing impaired
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Ear and labyrinth disorders
Tinnitus
|
1.3%
1/78 • Number of events 5
|
0.00%
0/72
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Endocrine disorders
Hyperthyroidism
|
5.1%
4/78 • Number of events 12
|
2.8%
2/72 • Number of events 3
|
|
Endocrine disorders
Hypothyroidism
|
24.4%
19/78 • Number of events 50
|
5.6%
4/72 • Number of events 12
|
|
Eye disorders
Blurred vision
|
2.6%
2/78 • Number of events 2
|
2.8%
2/72 • Number of events 3
|
|
Eye disorders
Dry eye
|
1.3%
1/78 • Number of events 1
|
2.8%
2/72 • Number of events 2
|
|
Eye disorders
Eye disorders - Other, specify
|
1.3%
1/78 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
|
Eye disorders
Floaters
|
0.00%
0/78
|
1.4%
1/72 • Number of events 2
|
|
Eye disorders
Glaucoma
|
1.3%
1/78 • Number of events 4
|
0.00%
0/72
|
|
Eye disorders
Watering eyes
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
12.8%
10/78 • Number of events 27
|
11.1%
8/72 • Number of events 12
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/78
|
1.4%
1/72 • Number of events 2
|
|
Gastrointestinal disorders
Anal mucositis
|
0.00%
0/78
|
1.4%
1/72 • Number of events 2
|
|
Gastrointestinal disorders
Bloating
|
2.6%
2/78 • Number of events 2
|
1.4%
1/72 • Number of events 1
|
|
Gastrointestinal disorders
Colonic obstruction
|
1.3%
1/78 • Number of events 2
|
1.4%
1/72 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
20.5%
16/78 • Number of events 29
|
15.3%
11/72 • Number of events 15
|
|
Gastrointestinal disorders
Dental caries
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Gastrointestinal disorders
Diarrhea
|
69.2%
54/78 • Number of events 305
|
52.8%
38/72 • Number of events 96
|
|
Gastrointestinal disorders
Dry mouth
|
20.5%
16/78 • Number of events 69
|
12.5%
9/72 • Number of events 14
|
|
Gastrointestinal disorders
Dyspepsia
|
28.2%
22/78 • Number of events 56
|
16.7%
12/72 • Number of events 23
|
|
Gastrointestinal disorders
Dysphagia
|
6.4%
5/78 • Number of events 8
|
2.8%
2/72 • Number of events 3
|
|
Gastrointestinal disorders
Esophagitis
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Gastrointestinal disorders
Fecal incontinence
|
2.6%
2/78 • Number of events 18
|
0.00%
0/72
|
|
Gastrointestinal disorders
Flatulence
|
5.1%
4/78 • Number of events 26
|
5.6%
4/72 • Number of events 6
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.7%
6/78 • Number of events 23
|
8.3%
6/72 • Number of events 10
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
7.7%
6/78 • Number of events 9
|
8.3%
6/72 • Number of events 15
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Gastrointestinal disorders
Gastroparesis
|
0.00%
0/78
|
1.4%
1/72 • Number of events 2
|
|
Gastrointestinal disorders
Gingival pain
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.6%
2/78 • Number of events 3
|
0.00%
0/72
|
|
Gastrointestinal disorders
Mucositis oral
|
38.5%
30/78 • Number of events 63
|
29.2%
21/72 • Number of events 50
|
|
Gastrointestinal disorders
Nausea
|
32.1%
25/78 • Number of events 77
|
36.1%
26/72 • Number of events 40
|
|
Gastrointestinal disorders
Oral dysesthesia
|
5.1%
4/78 • Number of events 14
|
2.8%
2/72 • Number of events 14
|
|
Gastrointestinal disorders
Oral hemorrhage
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Gastrointestinal disorders
Oral pain
|
11.5%
9/78 • Number of events 12
|
6.9%
5/72 • Number of events 6
|
|
Gastrointestinal disorders
Pancreatitis
|
2.6%
2/78 • Number of events 2
|
0.00%
0/72
|
|
Gastrointestinal disorders
Rectal pain
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Gastrointestinal disorders
Stomach pain
|
3.8%
3/78 • Number of events 4
|
1.4%
1/72 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
2.6%
2/78 • Number of events 2
|
0.00%
0/72
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
18/78 • Number of events 29
|
19.4%
14/72 • Number of events 21
|
|
General disorders
Chills
|
1.3%
1/78 • Number of events 1
|
5.6%
4/72 • Number of events 4
|
|
General disorders
Edema face
|
2.6%
2/78 • Number of events 4
|
1.4%
1/72 • Number of events 3
|
|
General disorders
Edema limbs
|
9.0%
7/78 • Number of events 38
|
13.9%
10/72 • Number of events 17
|
|
General disorders
Facial pain
|
2.6%
2/78 • Number of events 2
|
0.00%
0/72
|
|
General disorders
Fatigue
|
83.3%
65/78 • Number of events 414
|
80.6%
58/72 • Number of events 215
|
|
General disorders
Fever
|
3.8%
3/78 • Number of events 3
|
1.4%
1/72 • Number of events 1
|
|
General disorders
Flu like symptoms
|
5.1%
4/78 • Number of events 4
|
4.2%
3/72 • Number of events 4
|
|
General disorders
Gait disturbance
|
1.3%
1/78 • Number of events 3
|
1.4%
1/72 • Number of events 3
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
3.8%
3/78 • Number of events 5
|
6.9%
5/72 • Number of events 6
|
|
General disorders
Localized edema
|
2.6%
2/78 • Number of events 2
|
1.4%
1/72 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
2.6%
2/78 • Number of events 2
|
2.8%
2/72 • Number of events 2
|
|
General disorders
Pain
|
10.3%
8/78 • Number of events 11
|
6.9%
5/72 • Number of events 12
|
|
General disorders
Sudden death NOS
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Immune system disorders
Allergic reaction
|
1.3%
1/78 • Number of events 3
|
0.00%
0/72
|
|
Infections and infestations
Bladder infection
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Infections and infestations
Corneal infection
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Infections and infestations
Gum infection
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Infections and infestations
Infections and infestations - Oth spec
|
6.4%
5/78 • Number of events 6
|
6.9%
5/72 • Number of events 6
|
|
Infections and infestations
Lung infection
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Infections and infestations
Mucosal infection
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Infections and infestations
Otitis externa
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/78
|
5.6%
4/72 • Number of events 5
|
|
Infections and infestations
Paronychia
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Infections and infestations
Sinusitis
|
1.3%
1/78 • Number of events 3
|
1.4%
1/72 • Number of events 1
|
|
Infections and infestations
Skin infection
|
5.1%
4/78 • Number of events 6
|
1.4%
1/72 • Number of events 1
|
|
Infections and infestations
Stoma site infection
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Infections and infestations
Tooth infection
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Infections and infestations
Upper respiratory infection
|
1.3%
1/78 • Number of events 2
|
0.00%
0/72
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/78
|
5.6%
4/72 • Number of events 4
|
|
Injury, poisoning and procedural complications
Bruising
|
5.1%
4/78 • Number of events 12
|
0.00%
0/72
|
|
Injury, poisoning and procedural complications
Fall
|
3.8%
3/78 • Number of events 3
|
0.00%
0/72
|
|
Injury, poisoning and procedural complications
Fracture
|
1.3%
1/78 • Number of events 5
|
0.00%
0/72
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
2.6%
2/78 • Number of events 2
|
0.00%
0/72
|
|
Injury, poisoning and procedural complications
Venous injury
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Injury, poisoning and procedural complications
Wound complication
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/78
|
2.8%
2/72 • Number of events 2
|
|
Investigations
Activated partial throm time prolonged
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Investigations
Alanine aminotransferase increased
|
55.1%
43/78 • Number of events 135
|
26.4%
19/72 • Number of events 32
|
|
Investigations
Alkaline phosphatase increased
|
12.8%
10/78 • Number of events 17
|
11.1%
8/72 • Number of events 10
|
|
Investigations
Aspartate aminotransferase increased
|
62.8%
49/78 • Number of events 192
|
31.9%
23/72 • Number of events 36
|
|
Investigations
Blood bilirubin increased
|
14.1%
11/78 • Number of events 18
|
5.6%
4/72 • Number of events 8
|
|
Investigations
CD4 lymphocytes decreased
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Investigations
CPK increased
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Investigations
Cholesterol high
|
2.6%
2/78 • Number of events 6
|
0.00%
0/72
|
|
Investigations
Creatinine increased
|
23.1%
18/78 • Number of events 100
|
22.2%
16/72 • Number of events 55
|
|
Investigations
ECG QT corrected interval prolonged
|
5.1%
4/78 • Number of events 6
|
6.9%
5/72 • Number of events 5
|
|
Investigations
Ejection fraction decreased
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Investigations
INR increased
|
2.6%
2/78 • Number of events 7
|
1.4%
1/72 • Number of events 1
|
|
Investigations
Investigations - Other, specify
|
9.0%
7/78 • Number of events 22
|
2.8%
2/72 • Number of events 2
|
|
Investigations
Lipase increased
|
2.6%
2/78 • Number of events 6
|
1.4%
1/72 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
14.1%
11/78 • Number of events 24
|
19.4%
14/72 • Number of events 24
|
|
Investigations
Neutrophil count decreased
|
15.4%
12/78 • Number of events 35
|
31.9%
23/72 • Number of events 93
|
|
Investigations
Platelet count decreased
|
41.0%
32/78 • Number of events 131
|
59.7%
43/72 • Number of events 103
|
|
Investigations
Serum amylase increased
|
2.6%
2/78 • Number of events 6
|
0.00%
0/72
|
|
Investigations
Weight gain
|
0.00%
0/78
|
2.8%
2/72 • Number of events 3
|
|
Investigations
Weight loss
|
35.9%
28/78 • Number of events 145
|
16.7%
12/72 • Number of events 32
|
|
Investigations
White blood cell decreased
|
12.8%
10/78 • Number of events 39
|
33.3%
24/72 • Number of events 86
|
|
Metabolism and nutrition disorders
Anorexia
|
47.4%
37/78 • Number of events 92
|
31.9%
23/72 • Number of events 46
|
|
Metabolism and nutrition disorders
Dehydration
|
9.0%
7/78 • Number of events 10
|
8.3%
6/72 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.6%
2/78 • Number of events 2
|
4.2%
3/72 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.5%
16/78 • Number of events 30
|
15.3%
11/72 • Number of events 47
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
9.0%
7/78 • Number of events 11
|
9.7%
7/72 • Number of events 9
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/78
|
4.2%
3/72 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.1%
4/78 • Number of events 5
|
1.4%
1/72 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/78
|
1.4%
1/72 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
21.8%
17/78 • Number of events 47
|
18.1%
13/72 • Number of events 19
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.5%
16/78 • Number of events 62
|
13.9%
10/72 • Number of events 14
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.8%
3/78 • Number of events 4
|
0.00%
0/72
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
13/78 • Number of events 35
|
6.9%
5/72 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
24.4%
19/78 • Number of events 92
|
11.1%
8/72 • Number of events 20
|
|
Metabolism and nutrition disorders
Hyponatremia
|
15.4%
12/78 • Number of events 25
|
20.8%
15/72 • Number of events 24
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
24.4%
19/78 • Number of events 62
|
15.3%
11/72 • Number of events 21
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
3.8%
3/78 • Number of events 6
|
1.4%
1/72 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.0%
7/78 • Number of events 26
|
8.3%
6/72 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.3%
8/78 • Number of events 20
|
6.9%
5/72 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.4%
5/78 • Number of events 16
|
2.8%
2/72 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.6%
2/78 • Number of events 3
|
1.4%
1/72 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.3%
1/78 • Number of events 4
|
2.8%
2/72 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.6%
2/78 • Number of events 7
|
9.7%
7/72 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
1.3%
1/78 • Number of events 8
|
0.00%
0/72
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.3%
1/78 • Number of events 16
|
2.8%
2/72 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/78
|
1.4%
1/72 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
5.1%
4/78 • Number of events 33
|
2.8%
2/72 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.0%
7/78 • Number of events 52
|
6.9%
5/72 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.6%
2/78 • Number of events 3
|
4.2%
3/72 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.3%
8/78 • Number of events 16
|
8.3%
6/72 • Number of events 9
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Nervous system disorders
Concentration impairment
|
1.3%
1/78 • Number of events 2
|
0.00%
0/72
|
|
Nervous system disorders
Dizziness
|
21.8%
17/78 • Number of events 32
|
20.8%
15/72 • Number of events 21
|
|
Nervous system disorders
Dysgeusia
|
41.0%
32/78 • Number of events 98
|
29.2%
21/72 • Number of events 58
|
|
Nervous system disorders
Dysphasia
|
2.6%
2/78 • Number of events 2
|
0.00%
0/72
|
|
Nervous system disorders
Headache
|
11.5%
9/78 • Number of events 22
|
12.5%
9/72 • Number of events 16
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Nervous system disorders
Memory impairment
|
3.8%
3/78 • Number of events 8
|
0.00%
0/72
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
3.8%
3/78 • Number of events 4
|
1.4%
1/72 • Number of events 1
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Nervous system disorders
Paresthesia
|
5.1%
4/78 • Number of events 14
|
1.4%
1/72 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.6%
2/78 • Number of events 6
|
0.00%
0/72
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.3%
8/78 • Number of events 41
|
5.6%
4/72 • Number of events 4
|
|
Nervous system disorders
Somnolence
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Nervous system disorders
Syncope
|
2.6%
2/78 • Number of events 2
|
0.00%
0/72
|
|
Nervous system disorders
Transient ischemic attacks
|
0.00%
0/78
|
2.8%
2/72 • Number of events 2
|
|
Nervous system disorders
Tremor
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Psychiatric disorders
Anxiety
|
9.0%
7/78 • Number of events 13
|
4.2%
3/72 • Number of events 4
|
|
Psychiatric disorders
Confusion
|
1.3%
1/78 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
|
Psychiatric disorders
Depression
|
5.1%
4/78 • Number of events 8
|
5.6%
4/72 • Number of events 7
|
|
Psychiatric disorders
Insomnia
|
10.3%
8/78 • Number of events 13
|
8.3%
6/72 • Number of events 11
|
|
Psychiatric disorders
Restlessness
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Renal and urinary disorders
Acute kidney injury
|
2.6%
2/78 • Number of events 11
|
1.4%
1/72 • Number of events 1
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.6%
2/78 • Number of events 18
|
5.6%
4/72 • Number of events 13
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/78
|
1.4%
1/72 • Number of events 2
|
|
Renal and urinary disorders
Hematuria
|
2.6%
2/78 • Number of events 4
|
2.8%
2/72 • Number of events 5
|
|
Renal and urinary disorders
Hemoglobinuria
|
0.00%
0/78
|
1.4%
1/72 • Number of events 2
|
|
Renal and urinary disorders
Proteinuria
|
7.7%
6/78 • Number of events 14
|
12.5%
9/72 • Number of events 12
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
1.3%
1/78 • Number of events 3
|
1.4%
1/72 • Number of events 4
|
|
Renal and urinary disorders
Urinary frequency
|
2.6%
2/78 • Number of events 18
|
2.8%
2/72 • Number of events 2
|
|
Renal and urinary disorders
Urinary incontinence
|
1.3%
1/78 • Number of events 4
|
0.00%
0/72
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Renal and urinary disorders
Urine discoloration
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.3%
1/78 • Number of events 4
|
0.00%
0/72
|
|
Reproductive system and breast disorders
Genital edema
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Reproductive system and breast disorders
Gynecomastia
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Reproductive system and breast disorders
Uterine hemorrhage
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.6%
2/78 • Number of events 4
|
0.00%
0/72
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.3%
1/78 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.5%
9/78 • Number of events 17
|
5.6%
4/72 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
13/78 • Number of events 33
|
16.7%
12/72 • Number of events 16
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.3%
8/78 • Number of events 9
|
4.2%
3/72 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.6%
2/78 • Number of events 2
|
0.00%
0/72
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
14.1%
11/78 • Number of events 32
|
1.4%
1/72 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/78
|
1.4%
1/72 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.6%
2/78 • Number of events 2
|
2.8%
2/72 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hemorrhage
|
1.3%
1/78 • Number of events 5
|
0.00%
0/72
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.3%
1/78 • Number of events 3
|
0.00%
0/72
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.7%
6/78 • Number of events 19
|
1.4%
1/72 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
1.3%
1/78 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/78
|
1.4%
1/72 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.4%
5/78 • Number of events 11
|
2.8%
2/72 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
10.3%
8/78 • Number of events 19
|
0.00%
0/72
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.6%
2/78 • Number of events 10
|
0.00%
0/72
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
13/78 • Number of events 42
|
2.8%
2/72 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.5%
16/78 • Number of events 50
|
9.7%
7/72 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
1.3%
1/78 • Number of events 1
|
1.4%
1/72 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrm
|
42.3%
33/78 • Number of events 119
|
33.3%
24/72 • Number of events 100
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.1%
4/78 • Number of events 16
|
5.6%
4/72 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
15.4%
12/78 • Number of events 27
|
4.2%
3/72 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
17.9%
14/78 • Number of events 26
|
12.5%
9/72 • Number of events 19
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
20.5%
16/78 • Number of events 71
|
11.1%
8/72 • Number of events 17
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
1.3%
1/78 • Number of events 2
|
1.4%
1/72 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
2.6%
2/78 • Number of events 3
|
0.00%
0/72
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
2.6%
2/78 • Number of events 5
|
2.8%
2/72 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Surgical and medical proced - Oth spec
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Vascular disorders
Flushing
|
1.3%
1/78 • Number of events 11
|
0.00%
0/72
|
|
Vascular disorders
Hot flashes
|
0.00%
0/78
|
2.8%
2/72 • Number of events 2
|
|
Vascular disorders
Hypertension
|
82.1%
64/78 • Number of events 328
|
68.1%
49/72 • Number of events 193
|
|
Vascular disorders
Hypotension
|
6.4%
5/78 • Number of events 5
|
2.8%
2/72 • Number of events 2
|
|
Vascular disorders
Peripheral ischemia
|
1.3%
1/78 • Number of events 1
|
0.00%
0/72
|
|
Vascular disorders
Thromboembolic event
|
1.3%
1/78 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60