Trial Outcomes & Findings for Nivolumab With Ipilimumab in Subjects With Neuroendocrine Tumors (NCT NCT03420521)
NCT ID: NCT03420521
Last Updated: 2024-01-09
Results Overview
The number of subjects who have at least one scan with an Objective Response (OR) of confirmed complete response (CR) or partial response (PR), per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions as assessed by CT scan: Objective Response (OR), a response of CR or PR from baseline to PD, palliative local therapy, or subsequent anticancer therapy; Complete Response (CR), the disappearance of all target lesions and any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm; Partial Response (PR), \>= 30% decrease in the sum of the longest diameters of target lesions, compared to baseline sum diameters
TERMINATED
PHASE2
9 participants
up to 24 months
2024-01-09
Participant Flow
Participant milestones
| Measure |
Nivolumab Plus Ipilimumab
Nivolumab 240mg IV over 60 minutes every 2 weeks (Q2W) Ipilimumab 1mg/kg IV over 30 minutes every 6 weeks (Q6W)
Nivolumab: 240mg IV over 60 minutes Q2W
Ipilimumab: 1mg/kg IV over 30 minutes Q6W
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nivolumab With Ipilimumab in Subjects With Neuroendocrine Tumors
Baseline characteristics by cohort
| Measure |
Nivolumab Plus Ipilimumab
n=9 Participants
Nivolumab-240 mg IV over 60 minutes Q2W Ipilimumab 1mg/kg IV over 30 minutes Q6W
Nivolumab: 240mg IV over 60 minutes Q2W
Ipilimumab: 1mg/kg IV over 30 minutes Q6W
|
|---|---|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=5 Participants
|
|
Tumor Site
Lung
|
6 Participants
n=5 Participants
|
|
Tumor Site
Pancreatic Neuroendocrine
|
2 Participants
n=5 Participants
|
|
Tumor Site
Small Bowel
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 24 monthsPopulation: One patient passed away during cycle 1 of therapy, from unrelated issue (colitis, not related to study drug) prior to first RECIST scans, thus was not assessable for ORR, DCR or DOR.
The number of subjects who have at least one scan with an Objective Response (OR) of confirmed complete response (CR) or partial response (PR), per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions as assessed by CT scan: Objective Response (OR), a response of CR or PR from baseline to PD, palliative local therapy, or subsequent anticancer therapy; Complete Response (CR), the disappearance of all target lesions and any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm; Partial Response (PR), \>= 30% decrease in the sum of the longest diameters of target lesions, compared to baseline sum diameters
Outcome measures
| Measure |
Nivolumab Plus Ipilimumab
n=8 Participants
Nivolumab-240 mg IV over 60 minutes Q2W Ipilimumab 1mg/kg IV over 30 minutes Q6W
Nivolumab: 240mg IV over 60 minutes Q2W
Ipilimumab: 1mg/kg IV over 30 minutes Q6W
|
|---|---|
|
Objective Response Rate (ORR) of Neuroendocrine Tumor (NET) of the Lung, Pancreas, and Gastrointestinal (GI) Tract
|
4 Participants
|
SECONDARY outcome
Timeframe: up to 27 monthsSafety as assessed by number of patients experiencing drug-related adverse events (safety and tolerability).
Outcome measures
| Measure |
Nivolumab Plus Ipilimumab
n=9 Participants
Nivolumab-240 mg IV over 60 minutes Q2W Ipilimumab 1mg/kg IV over 30 minutes Q6W
Nivolumab: 240mg IV over 60 minutes Q2W
Ipilimumab: 1mg/kg IV over 30 minutes Q6W
|
|---|---|
|
Number of Patients Experiencing Drug-related Adverse Events
|
8 Participants
|
SECONDARY outcome
Timeframe: up to 24 monthsSafety as assessed by number of patients experiencing dose-limiting toxicities (safety and tolerability).
Outcome measures
| Measure |
Nivolumab Plus Ipilimumab
n=9 Participants
Nivolumab-240 mg IV over 60 minutes Q2W Ipilimumab 1mg/kg IV over 30 minutes Q6W
Nivolumab: 240mg IV over 60 minutes Q2W
Ipilimumab: 1mg/kg IV over 30 minutes Q6W
|
|---|---|
|
Number of Patients Experiencing Dose-limiting Toxicities
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPercentage of patients treated with nivolumab and ipilimumab with no progressive disease (PD) at 6 months using Kaplan Meier estimate, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan: Progressive Disease (PD), \>= 20% increase in sum of target lesions' diameters, compared to smallest sum on study (including 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, or the appearance of new lesions.
Outcome measures
| Measure |
Nivolumab Plus Ipilimumab
n=9 Participants
Nivolumab-240 mg IV over 60 minutes Q2W Ipilimumab 1mg/kg IV over 30 minutes Q6W
Nivolumab: 240mg IV over 60 minutes Q2W
Ipilimumab: 1mg/kg IV over 30 minutes Q6W
|
|---|---|
|
Progression Free Survival (PFS) at 6 Months
|
44 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPercentage of patients treated with nivolumab and ipilimumab with no progressive disease (PD) at 12 months using Kaplan Meier estimate, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan: Progressive Disease (PD), \>= 20% increase in sum of target lesions' diameters, compared to smallest sum on study (including 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, or the appearance of new lesions.
Outcome measures
| Measure |
Nivolumab Plus Ipilimumab
n=9 Participants
Nivolumab-240 mg IV over 60 minutes Q2W Ipilimumab 1mg/kg IV over 30 minutes Q6W
Nivolumab: 240mg IV over 60 minutes Q2W
Ipilimumab: 1mg/kg IV over 30 minutes Q6W
|
|---|---|
|
Progression Free Survival (PFS) at 12 Months
|
44 percentage of participants
|
SECONDARY outcome
Timeframe: 24 monthsPercentage of patients treated with nivolumab and ipilimumab with no progressive disease (PD) at 24 months using Kaplan Meier estimate, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan: Progressive Disease (PD), \>= 20% increase in sum of target lesions' diameters, compared to smallest sum on study (including 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, or the appearance of new lesions.
Outcome measures
| Measure |
Nivolumab Plus Ipilimumab
n=9 Participants
Nivolumab-240 mg IV over 60 minutes Q2W Ipilimumab 1mg/kg IV over 30 minutes Q6W
Nivolumab: 240mg IV over 60 minutes Q2W
Ipilimumab: 1mg/kg IV over 30 minutes Q6W
|
|---|---|
|
Progression Free Survival (PFS) at 24 Months
|
33 percentage of participants
|
SECONDARY outcome
Timeframe: approximately 3 years 8 monthsTime (months) from date of randomization to progressive disease (PD) or death, whichever comes first, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan: Progressive Disease (PD), \>= 20% increase in sum of target lesions' diameters, compared to smallest sum on study (including 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, or the appearance of new lesions.
Outcome measures
| Measure |
Nivolumab Plus Ipilimumab
n=9 Participants
Nivolumab-240 mg IV over 60 minutes Q2W Ipilimumab 1mg/kg IV over 30 minutes Q6W
Nivolumab: 240mg IV over 60 minutes Q2W
Ipilimumab: 1mg/kg IV over 30 minutes Q6W
|
|---|---|
|
Median Progression Free Survival (PFS)
|
5.29 months
Interval 2.7 to
estimation has not been reached
|
SECONDARY outcome
Timeframe: approximately 3 years 8 monthsPopulation: One patient passed away during cycle 1 of therapy, from unrelated issue (colitis, not related to study drug) prior to first RECIST scans, thus was not assessable for ORR, DCR or DOR.
The number of subjects who have at least one scan with best overall response (BOR) of confirmed complete response (CR), partial response (PR), or stable disease (SD), per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions as assessed by CT scan: Best Overall Response (BOR), best response (CR, PR, or SD) from baseline to PD, palliative local therapy, or subsequent anticancer therapy; Complete Response (CR), the disappearance of all target lesions and any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm; Partial Response (PR), \>= 30% decrease in the sum of the longest diameters of target lesions, compared to baseline sum diameters; Stable Disease (SD), \<20% increase, \<30% decrease in the sum of the longest diameter of target lesions, no measurable increase in non-target lesions, and no new lesions.
Outcome measures
| Measure |
Nivolumab Plus Ipilimumab
n=8 Participants
Nivolumab-240 mg IV over 60 minutes Q2W Ipilimumab 1mg/kg IV over 30 minutes Q6W
Nivolumab: 240mg IV over 60 minutes Q2W
Ipilimumab: 1mg/kg IV over 30 minutes Q6W
|
|---|---|
|
Efficacy as Assessed by Disease Control Rate (DCR)
|
4 Participants
|
SECONDARY outcome
Timeframe: approximately 3 years 8 monthsPopulation: The duration of response is in reference to those patients who have had an objective response. In our study, 4 patients had an objective response, thus we reported duration of response on those 4 patients.
Time (months) from best overall response (BOR) of complete response (CR) or partial response (PR) to progressive disease (PD), per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions by CT scan: Best Overall Response (BOR), best response (CR, PR, or SD) from baseline to PD, palliative local therapy, or subsequent anticancer therapy; Complete Response (CR), the disappearance of all target lesions and any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm; Partial Response (PR), \>= 30% decrease in the sum of the longest diameters of target lesions, compared to baseline sum diameters; Progressive Disease (PD), \>= 20% increase in sum of target lesions' diameters, compared to smallest sum on study (including 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, or the appearance of new lesions.
Outcome measures
| Measure |
Nivolumab Plus Ipilimumab
n=4 Participants
Nivolumab-240 mg IV over 60 minutes Q2W Ipilimumab 1mg/kg IV over 30 minutes Q6W
Nivolumab: 240mg IV over 60 minutes Q2W
Ipilimumab: 1mg/kg IV over 30 minutes Q6W
|
|---|---|
|
Efficacy as Assessed by Duration of Response (DOR)
|
NA months
Interval 8.51 to
estimation has not been reached
|
SECONDARY outcome
Timeframe: approximately 3 years 8 monthsNumber of months participants stay alive after treatment with the combination of nivolumab and ipilimumab in subjects with advanced well-differentiated nonfunctional NET of the lung, pancreas or GI tract
Outcome measures
| Measure |
Nivolumab Plus Ipilimumab
n=9 Participants
Nivolumab-240 mg IV over 60 minutes Q2W Ipilimumab 1mg/kg IV over 30 minutes Q6W
Nivolumab: 240mg IV over 60 minutes Q2W
Ipilimumab: 1mg/kg IV over 30 minutes Q6W
|
|---|---|
|
Efficacy as Assessed by Overall Survival (OS)
|
NA months
Interval 19.12 to
estimation has not been reached
|
Adverse Events
Nivolumab Plus Ipilimumab
Serious adverse events
| Measure |
Nivolumab Plus Ipilimumab
n=9 participants at risk
Nivolumab-240 mg IV over 60 minutes Q2W Ipilimumab 1mg/kg IV over 30 minutes Q6W
Nivolumab: 240mg IV over 60 minutes Q2W
Ipilimumab: 1mg/kg IV over 30 minutes Q6W
|
|---|---|
|
Gastrointestinal disorders
Colitis
|
11.1%
1/9 • approximately 3 years 8 months
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
1/9 • approximately 3 years 8 months
|
|
Gastrointestinal disorders
Pancreatitis
|
11.1%
1/9 • approximately 3 years 8 months
|
|
Infections and infestations
Sepsis
|
11.1%
1/9 • approximately 3 years 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
11.1%
1/9 • approximately 3 years 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
11.1%
1/9 • approximately 3 years 8 months
|
Other adverse events
| Measure |
Nivolumab Plus Ipilimumab
n=9 participants at risk
Nivolumab-240 mg IV over 60 minutes Q2W Ipilimumab 1mg/kg IV over 30 minutes Q6W
Nivolumab: 240mg IV over 60 minutes Q2W
Ipilimumab: 1mg/kg IV over 30 minutes Q6W
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
55.6%
5/9 • Number of events 7 • approximately 3 years 8 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Ear and labyrinth disorders
Tinnitus
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Endocrine disorders
Hyperthyroidism
|
22.2%
2/9 • Number of events 3 • approximately 3 years 8 months
|
|
Endocrine disorders
Hypothyroidism
|
33.3%
3/9 • Number of events 7 • approximately 3 years 8 months
|
|
Eye disorders
Blurred vision
|
22.2%
2/9 • Number of events 2 • approximately 3 years 8 months
|
|
Eye disorders
Dry eye
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Eye disorders
Eye duct inflammation
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Gastrointestinal disorders
Abdominal distension
|
11.1%
1/9 • Number of events 2 • approximately 3 years 8 months
|
|
Gastrointestinal disorders
Abdominal pain
|
88.9%
8/9 • Number of events 16 • approximately 3 years 8 months
|
|
Gastrointestinal disorders
Anal pain
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Gastrointestinal disorders
Ascites
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Gastrointestinal disorders
Colitis
|
22.2%
2/9 • Number of events 2 • approximately 3 years 8 months
|
|
Gastrointestinal disorders
Constipation
|
33.3%
3/9 • Number of events 5 • approximately 3 years 8 months
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
6/9 • Number of events 22 • approximately 3 years 8 months
|
|
Gastrointestinal disorders
Dry mouth
|
11.1%
1/9 • Number of events 2 • approximately 3 years 8 months
|
|
Gastrointestinal disorders
Flatulence
|
22.2%
2/9 • Number of events 2 • approximately 3 years 8 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
11.1%
1/9 • Number of events 2 • approximately 3 years 8 months
|
|
Gastrointestinal disorders
Nausea
|
88.9%
8/9 • Number of events 12 • approximately 3 years 8 months
|
|
Gastrointestinal disorders
Pancreatitis
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
3/9 • Number of events 5 • approximately 3 years 8 months
|
|
General disorders
Chills
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
General disorders
Edema face
|
33.3%
3/9 • Number of events 4 • approximately 3 years 8 months
|
|
General disorders
Edema limbs
|
33.3%
3/9 • Number of events 8 • approximately 3 years 8 months
|
|
General disorders
Edema neck
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
General disorders
Edema periorbital
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
General disorders
Facial pain
|
11.1%
1/9 • Number of events 2 • approximately 3 years 8 months
|
|
General disorders
Fatigue
|
77.8%
7/9 • Number of events 21 • approximately 3 years 8 months
|
|
General disorders
Fever
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
General disorders
Hypothermia
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
General disorders
Non-cardiac chest pain
|
11.1%
1/9 • Number of events 2 • approximately 3 years 8 months
|
|
Infections and infestations
Upper respiratory infection
|
22.2%
2/9 • Number of events 3 • approximately 3 years 8 months
|
|
Injury, poisoning and procedural complications
Bruising
|
22.2%
2/9 • Number of events 5 • approximately 3 years 8 months
|
|
Injury, poisoning and procedural complications
Burn
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Investigations
Alkaline phosphatase increased
|
22.2%
2/9 • Number of events 10 • approximately 3 years 8 months
|
|
Investigations
ALT increased
|
33.3%
3/9 • Number of events 5 • approximately 3 years 8 months
|
|
Investigations
AST increased
|
22.2%
2/9 • Number of events 3 • approximately 3 years 8 months
|
|
Investigations
BUN increased
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Investigations
Cholesterol high
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Investigations
Creatinine increased
|
33.3%
3/9 • Number of events 6 • approximately 3 years 8 months
|
|
Investigations
HbA1c increased
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Investigations
Lactate dehydrogenase increased
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Investigations
Lipase increased
|
22.2%
2/9 • Number of events 23 • approximately 3 years 8 months
|
|
Investigations
Lymphocyte count decreased
|
44.4%
4/9 • Number of events 14 • approximately 3 years 8 months
|
|
Investigations
Serum amylase increased
|
11.1%
1/9 • Number of events 18 • approximately 3 years 8 months
|
|
Investigations
Weight loss
|
22.2%
2/9 • Number of events 4 • approximately 3 years 8 months
|
|
Metabolism and nutrition disorders
Acidosis
|
22.2%
2/9 • Number of events 3 • approximately 3 years 8 months
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
3/9 • Number of events 3 • approximately 3 years 8 months
|
|
Metabolism and nutrition disorders
Dehydration
|
22.2%
2/9 • Number of events 4 • approximately 3 years 8 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.1%
1/9 • Number of events 2 • approximately 3 years 8 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
22.2%
2/9 • Number of events 2 • approximately 3 years 8 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
11.1%
1/9 • Number of events 2 • approximately 3 years 8 months
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
1/9 • Number of events 2 • approximately 3 years 8 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
22.2%
2/9 • Number of events 3 • approximately 3 years 8 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
1/9 • Number of events 2 • approximately 3 years 8 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
22.2%
2/9 • Number of events 4 • approximately 3 years 8 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
44.4%
4/9 • Number of events 5 • approximately 3 years 8 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
33.3%
3/9 • Number of events 4 • approximately 3 years 8 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
11.1%
1/9 • Number of events 2 • approximately 3 years 8 months
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
3/9 • Number of events 5 • approximately 3 years 8 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Baker's cyst
|
11.1%
1/9 • Number of events 2 • approximately 3 years 8 months
|
|
Nervous system disorders
Ataxia
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Nervous system disorders
Dizziness
|
33.3%
3/9 • Number of events 3 • approximately 3 years 8 months
|
|
Nervous system disorders
Headache
|
22.2%
2/9 • Number of events 2 • approximately 3 years 8 months
|
|
Nervous system disorders
Lethargy
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Nervous system disorders
Nipple sensitivity
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Nervous system disorders
Paresthesia
|
22.2%
2/9 • Number of events 3 • approximately 3 years 8 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
3/9 • Number of events 4 • approximately 3 years 8 months
|
|
Psychiatric disorders
Anxiety
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Psychiatric disorders
Insomnia
|
44.4%
4/9 • Number of events 4 • approximately 3 years 8 months
|
|
Renal and urinary disorders
Acute kidney injury
|
22.2%
2/9 • Number of events 2 • approximately 3 years 8 months
|
|
Renal and urinary disorders
Urinary frequency
|
33.3%
3/9 • Number of events 4 • approximately 3 years 8 months
|
|
Renal and urinary disorders
Urinary urgency
|
11.1%
1/9 • Number of events 2 • approximately 3 years 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
3/9 • Number of events 8 • approximately 3 years 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
55.6%
5/9 • Number of events 11 • approximately 3 years 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
3/9 • Number of events 5 • approximately 3 years 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
33.3%
3/9 • Number of events 4 • approximately 3 years 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
33.3%
3/9 • Number of events 7 • approximately 3 years 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
22.2%
2/9 • Number of events 2 • approximately 3 years 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
22.2%
2/9 • Number of events 2 • approximately 3 years 8 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
3/9 • Number of events 3 • approximately 3 years 8 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
22.2%
2/9 • Number of events 3 • approximately 3 years 8 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
22.2%
2/9 • Number of events 4 • approximately 3 years 8 months
|
|
Skin and subcutaneous tissue disorders
Peeling skin on hands
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
66.7%
6/9 • Number of events 10 • approximately 3 years 8 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
22.2%
2/9 • Number of events 2 • approximately 3 years 8 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
66.7%
6/9 • Number of events 19 • approximately 3 years 8 months
|
|
Vascular disorders
Flushing
|
11.1%
1/9 • Number of events 1 • approximately 3 years 8 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place