Trial Outcomes & Findings for A Phase 2 Study of the MET Kinase Inhibitor INC280 in Papillary Renal Cell Cancer (NCT NCT02019693)
NCT ID: NCT02019693
Last Updated: 2023-03-21
Results Overview
Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete Response (CR) is disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
From start of study until permanent treatment discontinuation (range 2 weeks-238 weeks)
Results posted on
2023-03-21
Participant Flow
Participant milestones
| Measure |
Capmatinib (INC280)
Participants received a starting dose of 600mg twice a day (BID) of capmatinib initially; following a change in formulation during the study, the starting dose was changed to 400mg BID, based on pharmacokinetic (PK) studies that demonstrated that this corresponded to the starting dose of 600mg BID of the old formulation.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 2 Study of the MET Kinase Inhibitor INC280 in Papillary Renal Cell Cancer
Baseline characteristics by cohort
| Measure |
Capmatinib (INC280)
n=20 Participants
Participants received a starting dose of 600mg twice a day (BID) of capmatinib initially; following a change in formulation during the study, the starting dose was changed to 400mg BID, based on pharmacokinetic (PK) studies that demonstrated that this corresponded to the starting dose of 600mg BID of the old formulation.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
55.63 years
STANDARD_DEVIATION 10.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of study until permanent treatment discontinuation (range 2 weeks-238 weeks)Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete Response (CR) is disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Capmatinib (INC280)
n=20 Participants
Participants received a starting dose of 600mg twice a day (BID) of capmatinib initially; following a change in formulation during the study, the starting dose was changed to 400mg BID, based on pharmacokinetic (PK) studies that demonstrated that this corresponded to the starting dose of 600mg BID of the old formulation.
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|---|---|
|
Percentage of Participants With Response
Complete Response
|
0 percentage of participants
|
|
Percentage of Participants With Response
Partial Response
|
15 percentage of participants
|
|
Percentage of Participants With Response
Stable Disease
|
65 percentage of participants
|
|
Percentage of Participants With Response
Progressive Disease
|
10 percentage of participants
|
|
Percentage of Participants With Response
Not evaluable for response
|
10 percentage of participants
|
SECONDARY outcome
Timeframe: Median 26.8 monthsPFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.
Outcome measures
| Measure |
Capmatinib (INC280)
n=20 Participants
Participants received a starting dose of 600mg twice a day (BID) of capmatinib initially; following a change in formulation during the study, the starting dose was changed to 400mg BID, based on pharmacokinetic (PK) studies that demonstrated that this corresponded to the starting dose of 600mg BID of the old formulation.
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|---|---|
|
Progression Free Survival (PFS)
|
10.2 Months
Interval 3.67 to
The upper bounds of the 95% confidence interval (CI) were not reached at the time of this analysis.
|
SECONDARY outcome
Timeframe: Median 26.8 monthsOS is the time between the first day of treatment and day of death or last follow up calculated by Kaplan Meier analysis.
Outcome measures
| Measure |
Capmatinib (INC280)
n=20 Participants
Participants received a starting dose of 600mg twice a day (BID) of capmatinib initially; following a change in formulation during the study, the starting dose was changed to 400mg BID, based on pharmacokinetic (PK) studies that demonstrated that this corresponded to the starting dose of 600mg BID of the old formulation.
|
|---|---|
|
Overall Survival
|
31 Months
Interval 21.9 to
The upper bounds of the 95% confidence interval (CI) were not reached at the time of this analysis.
|
SECONDARY outcome
Timeframe: From start of study until permanent treatment discontinuation (range 2 weeks-238 weeks)Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete Response (CR) is disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Capmatinib (INC280)
n=20 Participants
Participants received a starting dose of 600mg twice a day (BID) of capmatinib initially; following a change in formulation during the study, the starting dose was changed to 400mg BID, based on pharmacokinetic (PK) studies that demonstrated that this corresponded to the starting dose of 600mg BID of the old formulation.
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|---|---|
|
Disease Control Rate (Partial and Complete Response Plus Stable Disease > 6 Months)
|
35 percentage of participants
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 94 months and 21 daysAdverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.
Outcome measures
| Measure |
Capmatinib (INC280)
n=20 Participants
Participants received a starting dose of 600mg twice a day (BID) of capmatinib initially; following a change in formulation during the study, the starting dose was changed to 400mg BID, based on pharmacokinetic (PK) studies that demonstrated that this corresponded to the starting dose of 600mg BID of the old formulation.
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|---|---|
|
Number of Grades 1-5 Adverse Events Related to Treatment
Grade 1
|
228 adverse events
|
|
Number of Grades 1-5 Adverse Events Related to Treatment
Grade 2
|
81 adverse events
|
|
Number of Grades 1-5 Adverse Events Related to Treatment
Grade 3
|
13 adverse events
|
|
Number of Grades 1-5 Adverse Events Related to Treatment
Grade 4
|
3 adverse events
|
|
Number of Grades 1-5 Adverse Events Related to Treatment
Grade 5
|
0 adverse events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Date treatment consent signed to date off study, approximately 94 months and 21 daysHere is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Capmatinib (INC280)
n=20 Participants
Participants received a starting dose of 600mg twice a day (BID) of capmatinib initially; following a change in formulation during the study, the starting dose was changed to 400mg BID, based on pharmacokinetic (PK) studies that demonstrated that this corresponded to the starting dose of 600mg BID of the old formulation.
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|---|---|
|
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
|
20 Participants
|
Adverse Events
Capmatinib (INC280)
Serious events: 6 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Capmatinib (INC280)
n=20 participants at risk
Participants received a starting dose of 600mg twice a day (BID) of capmatinib initially; following a change in formulation during the study, the starting dose was changed to 400mg BID, based on pharmacokinetic (PK) studies that demonstrated that this corresponded to the starting dose of 600mg BID of the old formulation.
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Cardiac disorders
Atrial fibrillation
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
General disorders
Fever
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Thyroid mass
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
General disorders
Pain
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Nervous system disorders
Syncope
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
Other adverse events
| Measure |
Capmatinib (INC280)
n=20 participants at risk
Participants received a starting dose of 600mg twice a day (BID) of capmatinib initially; following a change in formulation during the study, the starting dose was changed to 400mg BID, based on pharmacokinetic (PK) studies that demonstrated that this corresponded to the starting dose of 600mg BID of the old formulation.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
5/20 • Number of events 6 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
5/20 • Number of events 10 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Investigations
Alkaline phosphatase increased
|
10.0%
2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Blood and lymphatic system disorders
Anemia
|
30.0%
6/20 • Number of events 13 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Metabolism and nutrition disorders
Anorexia
|
15.0%
3/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Psychiatric disorders
Anxiety
|
25.0%
5/20 • Number of events 5 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
5/20 • Number of events 7 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Nervous system disorders
Ataxia
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.0%
3/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Investigations
Blood bilirubin increased
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Eye disorders
Blurred vision
|
10.0%
2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Injury, poisoning and procedural complications
Burn
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Investigations
CPK increased
|
10.0%
2/20 • Number of events 14 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Cardiac disorders
Chest pain - cardiac
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
10.0%
2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
General disorders
Chills
|
30.0%
6/20 • Number of events 7 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Investigations
Cholesterol high
|
10.0%
2/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
4/20 • Number of events 4 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
5/20 • Number of events 8 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Investigations
Creatinine increased
|
75.0%
15/20 • Number of events 49 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Psychiatric disorders
Depression
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Gastrointestinal disorders
Diarrhea
|
60.0%
12/20 • Number of events 19 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Nervous system disorders
Dizziness
|
30.0%
6/20 • Number of events 9 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Eye disorders
Dry eye
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Nervous system disorders
Dysgeusia
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Gastrointestinal disorders
Dyspepsia
|
60.0%
12/20 • Number of events 23 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
General disorders
Edema face
|
5.0%
1/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
General disorders
Edema limbs
|
45.0%
9/20 • Number of events 32 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Eye disorders
Eye disorders - Other, Left eye subconjunctival hemorrhage
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Eye disorders
Eye disorders - Other, Right eye stye
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
General disorders
Fatigue
|
55.0%
11/20 • Number of events 17 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
General disorders
Fever
|
20.0%
4/20 • Number of events 6 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Eye disorders
Flashing lights
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
General disorders
Flu like symptoms
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Gastrointestinal disorders
Gastritis
|
5.0%
1/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.0%
2/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, diverticulosis
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
General disorders
General disorders and administration site conditions - Other, Sweats
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Reproductive system and breast disorders
Genital edema
|
10.0%
2/20 • Number of events 6 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Reproductive system and breast disorders
Gynecomastia
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Nervous system disorders
Headache
|
35.0%
7/20 • Number of events 8 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Renal and urinary disorders
Hemoglobinuria
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
5/20 • Number of events 14 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Endocrine disorders
Hyperparathyroidism
|
10.0%
2/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
20.0%
4/20 • Number of events 5 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
20.0%
4/20 • Number of events 14 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
10/20 • Number of events 19 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
4/20 • Number of events 19 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
10.0%
2/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.0%
1/20 • Number of events 7 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
30.0%
6/20 • Number of events 8 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
45.0%
9/20 • Number of events 21 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Vascular disorders
Hypotension
|
25.0%
5/20 • Number of events 6 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Endocrine disorders
Hypothyroidism
|
10.0%
2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Psychiatric disorders
Insomnia
|
15.0%
3/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
General disorders
Irritability
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Investigations
Lipase increased
|
35.0%
7/20 • Number of events 16 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
General disorders
Localized edema
|
5.0%
1/20 • Number of events 4 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Investigations
Lymphocyte count decreased
|
55.0%
11/20 • Number of events 27 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Nervous system disorders
Memory impairment
|
10.0%
2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
5/20 • Number of events 8 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
15.0%
3/20 • Number of events 7 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Gastrointestinal disorders
Nausea
|
80.0%
16/20 • Number of events 20 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Benign Thyroid Neoplasm
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Nervous system disorders
Nervous system disorders - Other, numbness sinus area
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Nervous system disorders
Neuralgia
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Investigations
Neutrophil count decreased
|
10.0%
2/20 • Number of events 28 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Gastrointestinal disorders
Oral pain
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
General disorders
Pain
|
50.0%
10/20 • Number of events 20 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Cardiac disorders
Palpitations
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Reproductive system and breast disorders
Penile pain
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Eye disorders
Photophobia
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Investigations
Platelet count decreased
|
30.0%
6/20 • Number of events 18 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
2/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Renal and urinary disorders
Proteinuria
|
15.0%
3/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.0%
3/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
15.0%
3/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Investigations
Serum amylase increased
|
30.0%
6/20 • Number of events 9 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Cardiac disorders
Sinus bradycardia
|
25.0%
5/20 • Number of events 11 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Seborrheic keratosis
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Skin lesions
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Infections and infestations
Skin infection
|
5.0%
1/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Gastrointestinal disorders
Toothache
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Renal and urinary disorders
Urinary frequency
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Renal and urinary disorders
Urinary incontinence
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
3/20 • Number of events 10 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Investigations
Weight gain
|
20.0%
4/20 • Number of events 8 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
|
Investigations
White blood cell decreased
|
20.0%
4/20 • Number of events 28 • Date treatment consent signed to date off study, approximately 94 months and 21 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place