Trial Outcomes & Findings for The Life After Stopping Tyrosine Kinase Inhibitors Study (The LAST Study) (NCT NCT02269267)
NCT ID: NCT02269267
Last Updated: 2023-03-03
Results Overview
The number of patients who develop molecular recurrence after discontinuing TKIs. This will be reported as the number of new occurrences from the end of the prior time frame.
COMPLETED
PHASE2
173 participants
1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 27, 30, 33, 36 months
2023-03-03
Participant Flow
Participant milestones
| Measure |
Discontinuation of TKI Medication
Patients with CML on treatment with imatinib, dasatinib, nilotinib, or bosutinib and are in confirmed deep molecular response will stop their TKI. Confirmed deep (\> 4 log reduction) molecular response (\>MR4) defined as p210 (bcr-abl) fusion protein (BCR-ABL) \< 0.01%, for at least two years.
Concurrently, the study will assess a wide range of PROs before stopping TKIs and after discontinuation in conjunction with polymerase chain reaction (PCR) testing, though at fewer time points, utilizing online and/or phone questionnaires.
|
|---|---|
|
Overall Study
STARTED
|
173
|
|
Overall Study
COMPLETED
|
168
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Discontinuation of TKI Medication
Patients with CML on treatment with imatinib, dasatinib, nilotinib, or bosutinib and are in confirmed deep molecular response will stop their TKI. Confirmed deep (\> 4 log reduction) molecular response (\>MR4) defined as p210 (bcr-abl) fusion protein (BCR-ABL) \< 0.01%, for at least two years.
Concurrently, the study will assess a wide range of PROs before stopping TKIs and after discontinuation in conjunction with polymerase chain reaction (PCR) testing, though at fewer time points, utilizing online and/or phone questionnaires.
|
|---|---|
|
Overall Study
Death
|
5
|
Baseline Characteristics
The Life After Stopping Tyrosine Kinase Inhibitors Study (The LAST Study)
Baseline characteristics by cohort
| Measure |
Discontinuation of TKI Medication
n=172 Participants
Patients with CML on treatment with imatinib, dasatinib, nilotinib, or bosutinib and are in confirmed deep molecular response will stop their TKI. Confirmed deep (\> 4 log reduction) molecular response (\>MR4) defined as p210 (bcr-abl) fusion protein (BCR-ABL) \< 0.01%, for at least two years.
Concurrently, the study will assess a wide range of PROs before stopping TKIs and after discontinuation in conjunction with PCR testing, though at fewer time points, utilizing online and/or phone questionnaires.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
123 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
153 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 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
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
139 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
172 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 27, 30, 33, 36 monthsPopulation: One subject expired after the 10th month visit.
The number of patients who develop molecular recurrence after discontinuing TKIs. This will be reported as the number of new occurrences from the end of the prior time frame.
Outcome measures
| Measure |
Discontinuation of TKI Medication
n=172 Participants
Patients with CML on treatment with imatinib, dasatinib, nilotinib, or bosutinib and are in confirmed deep molecular response will stop their TKI. Confirmed deep (\> 4 log reduction) molecular response (\>MR4) defined as p210 (bcr-abl) fusion protein (BCR-ABL) \< 0.01%, for at least two years.
Concurrently, the study will assess a wide range of PROs before stopping TKIs and after discontinuation in conjunction with PCR testing, though at fewer time points, utilizing online and/or phone questionnaires.
|
|---|---|
|
Number of Patients With Chronic Myeloid Leukemia (CML) Who Develop Molecular Recurrence After Discontinuing TKIs.
Less or equal to one month
|
0 Participants
|
|
Number of Patients With Chronic Myeloid Leukemia (CML) Who Develop Molecular Recurrence After Discontinuing TKIs.
One month to two months
|
4 Participants
|
|
Number of Patients With Chronic Myeloid Leukemia (CML) Who Develop Molecular Recurrence After Discontinuing TKIs.
Two months to three months
|
12 Participants
|
|
Number of Patients With Chronic Myeloid Leukemia (CML) Who Develop Molecular Recurrence After Discontinuing TKIs.
Three months to four months
|
11 Participants
|
|
Number of Patients With Chronic Myeloid Leukemia (CML) Who Develop Molecular Recurrence After Discontinuing TKIs.
Four months to five months
|
7 Participants
|
|
Number of Patients With Chronic Myeloid Leukemia (CML) Who Develop Molecular Recurrence After Discontinuing TKIs.
Five months to six months
|
5 Participants
|
|
Number of Patients With Chronic Myeloid Leukemia (CML) Who Develop Molecular Recurrence After Discontinuing TKIs.
Six months to eight months
|
2 Participants
|
|
Number of Patients With Chronic Myeloid Leukemia (CML) Who Develop Molecular Recurrence After Discontinuing TKIs.
Eight months to 10 months
|
3 Participants
|
|
Number of Patients With Chronic Myeloid Leukemia (CML) Who Develop Molecular Recurrence After Discontinuing TKIs.
Ten months to 12 months
|
4 Participants
|
|
Number of Patients With Chronic Myeloid Leukemia (CML) Who Develop Molecular Recurrence After Discontinuing TKIs.
12 months to 14 months
|
2 Participants
|
|
Number of Patients With Chronic Myeloid Leukemia (CML) Who Develop Molecular Recurrence After Discontinuing TKIs.
14 months to 16 months
|
2 Participants
|
|
Number of Patients With Chronic Myeloid Leukemia (CML) Who Develop Molecular Recurrence After Discontinuing TKIs.
16 months to 18 months
|
1 Participants
|
|
Number of Patients With Chronic Myeloid Leukemia (CML) Who Develop Molecular Recurrence After Discontinuing TKIs.
18 months to 20 months
|
0 Participants
|
|
Number of Patients With Chronic Myeloid Leukemia (CML) Who Develop Molecular Recurrence After Discontinuing TKIs.
20 months to 22 months
|
0 Participants
|
|
Number of Patients With Chronic Myeloid Leukemia (CML) Who Develop Molecular Recurrence After Discontinuing TKIs.
22 months to 24 months
|
1 Participants
|
|
Number of Patients With Chronic Myeloid Leukemia (CML) Who Develop Molecular Recurrence After Discontinuing TKIs.
24 months to 27 months
|
1 Participants
|
|
Number of Patients With Chronic Myeloid Leukemia (CML) Who Develop Molecular Recurrence After Discontinuing TKIs.
27 months to 30 months
|
2 Participants
|
|
Number of Patients With Chronic Myeloid Leukemia (CML) Who Develop Molecular Recurrence After Discontinuing TKIs.
30 months to 33 months
|
0 Participants
|
|
Number of Patients With Chronic Myeloid Leukemia (CML) Who Develop Molecular Recurrence After Discontinuing TKIs.
33 months to 36 months
|
0 Participants
|
|
Number of Patients With Chronic Myeloid Leukemia (CML) Who Develop Molecular Recurrence After Discontinuing TKIs.
36 months
|
2 Participants
|
PRIMARY outcome
Timeframe: BaselinePatient-reported health status of fatigue using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales. The research team used five questions. The responses are in a Likert -style scale numbered one to five -- 1 (not at all) and 5 (very much). PROMIS scales use a T-score metric for interpretation of results. The mean score for a relevant reference population (United States general population in this case) is 50 and 10 is the standard deviation of that population. T-score range is 20 to 80. Thus, a score of 40 is one standard deviation lower than the reference population mean and a score of 60 is one standard deviation higher than the reference population mean. Higher scores for this scale are indicative of worse symptoms.
Outcome measures
| Measure |
Discontinuation of TKI Medication
n=172 Participants
Patients with CML on treatment with imatinib, dasatinib, nilotinib, or bosutinib and are in confirmed deep molecular response will stop their TKI. Confirmed deep (\> 4 log reduction) molecular response (\>MR4) defined as p210 (bcr-abl) fusion protein (BCR-ABL) \< 0.01%, for at least two years.
Concurrently, the study will assess a wide range of PROs before stopping TKIs and after discontinuation in conjunction with PCR testing, though at fewer time points, utilizing online and/or phone questionnaires.
|
|---|---|
|
Patient-reported Health Status Related to Fatigue of Patients at Baseline (Before Stopping Tyrosine Kinase Inhibitors (TKIs)
|
52.9 T-Score
Standard Deviation 9.9
|
PRIMARY outcome
Timeframe: Six monthsPatient-reported health status of fatigue using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales. The research team used five questions. The responses are in a Likert -style scale numbered one to five -- 1 (not at all) and 5 (very much). PROMIS scales use a T-score metric for interpretation of results. The mean score for a relevant reference population (United States general population in this case) is 50 and 10 is the standard deviation of that population. T-score range is 20 to 80. Thus, a score of 40 is one standard deviation lower than the reference population mean and a score of 60 is one standard deviation higher than the reference population mean. Higher scores for this scale are indicative of worse symptoms.
Outcome measures
| Measure |
Discontinuation of TKI Medication
n=172 Participants
Patients with CML on treatment with imatinib, dasatinib, nilotinib, or bosutinib and are in confirmed deep molecular response will stop their TKI. Confirmed deep (\> 4 log reduction) molecular response (\>MR4) defined as p210 (bcr-abl) fusion protein (BCR-ABL) \< 0.01%, for at least two years.
Concurrently, the study will assess a wide range of PROs before stopping TKIs and after discontinuation in conjunction with PCR testing, though at fewer time points, utilizing online and/or phone questionnaires.
|
|---|---|
|
Patient-reported Health Status Related to Fatigue of Patients at 6 Months (After Stopping Tyrosine Kinase Inhibitors (TKIs)
|
50.2 T-Score
Standard Deviation 11.1
|
PRIMARY outcome
Timeframe: BaselinePatient-reported health status of diarrhea using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales. There are two unrelated questions. Question no. 1 focuses on loose or watery stool and asks how many days the subject experienced this. O is no days and 4 is six to seven days. Question no. 2 asks if the subject often feels the need to empty the bowel right away. Responses are 0 (never) to 4 (more than once a day). Responses are a Likert -style scale numbered one to five -- 1 (not at all) and 5 (very much). PROMIS scales use a T-score metric interpret results. The mean score for a relevant reference population (United States general population) is 50 and 10 is the standard deviation of the population. T-score range is 20 to 80. A score of 40 is one standard deviation lower than the reference population mean and 60 is one standard deviation higher than the reference population mean. Higher scores indicate worse symptoms.
Outcome measures
| Measure |
Discontinuation of TKI Medication
n=172 Participants
Patients with CML on treatment with imatinib, dasatinib, nilotinib, or bosutinib and are in confirmed deep molecular response will stop their TKI. Confirmed deep (\> 4 log reduction) molecular response (\>MR4) defined as p210 (bcr-abl) fusion protein (BCR-ABL) \< 0.01%, for at least two years.
Concurrently, the study will assess a wide range of PROs before stopping TKIs and after discontinuation in conjunction with PCR testing, though at fewer time points, utilizing online and/or phone questionnaires.
|
|---|---|
|
Patient-reported Health Status Related to Diarrhea of Patients at Baseline (Before Stopping Tyrosine Kinase Inhibitors (TKIs)
|
43.6 T-Score
Standard Deviation 8.3
|
PRIMARY outcome
Timeframe: Six monthsPatient-reported health status of diarrhea using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales. There are two unrelated questions. Question no. 1 focuses on loose or watery stool and asks how many days the subject experienced this. O is no days and 4 is six to seven days. Question no. 2 asks if the subject often feels the need to empty the bowel right away. Responses are 0 (never) to 4 (more than once a day). Responses are a Likert -style scale numbered one to five -- 1 (not at all) and 5 (very much). PROMIS scales use a T-score metric interpret results. The mean score for a relevant reference population (United States general population) is 50 and 10 is the standard deviation of the population. T-score range is 20 to 80. A score of 40 is one standard deviation lower than the reference population mean and 60 is one standard deviation higher than the reference population mean. Higher scores indicate worse symptoms.
Outcome measures
| Measure |
Discontinuation of TKI Medication
n=172 Participants
Patients with CML on treatment with imatinib, dasatinib, nilotinib, or bosutinib and are in confirmed deep molecular response will stop their TKI. Confirmed deep (\> 4 log reduction) molecular response (\>MR4) defined as p210 (bcr-abl) fusion protein (BCR-ABL) \< 0.01%, for at least two years.
Concurrently, the study will assess a wide range of PROs before stopping TKIs and after discontinuation in conjunction with PCR testing, though at fewer time points, utilizing online and/or phone questionnaires.
|
|---|---|
|
Patient-reported Health Status Related to Diarrhea of Patients at 6 Months (After Stopping Tyrosine Kinase Inhibitors (TKIs)
|
40.8 T-Score
Standard Deviation 9.2
|
PRIMARY outcome
Timeframe: BaselinePatient-reported health status of sleep using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales. There are four questions. The responses are in a Likert Scale numbered one to five. All questions are regarding the quality of sleep. The answers are one (not at all) to 5 (very much). PROMIS scales use a T-score metric interpret results. The mean score for a relevant reference population (United States general population) is 50 and 10 is the standard deviation of the population. T-score range is 20 to 80. A score of 40 is one standard deviation lower than the reference population mean and 60 is one standard deviation higher than the reference population mean. Higher scores indicate worse symptoms.
Outcome measures
| Measure |
Discontinuation of TKI Medication
n=172 Participants
Patients with CML on treatment with imatinib, dasatinib, nilotinib, or bosutinib and are in confirmed deep molecular response will stop their TKI. Confirmed deep (\> 4 log reduction) molecular response (\>MR4) defined as p210 (bcr-abl) fusion protein (BCR-ABL) \< 0.01%, for at least two years.
Concurrently, the study will assess a wide range of PROs before stopping TKIs and after discontinuation in conjunction with PCR testing, though at fewer time points, utilizing online and/or phone questionnaires.
|
|---|---|
|
Patient-reported Health Status Related to Sleep Status of Patients at Baseline (Before Stopping Tyrosine Kinase Inhibitors (TKIs)
|
49.7 T-Score
Standard Deviation 8.2
|
PRIMARY outcome
Timeframe: Six monthsPatient-reported health status of sleep using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales. There are four questions. The responses are in a Likert Scale numbered one to five. All questions are regarding the quality of sleep. The answers are one (not at all) to 5 (very much). PROMIS scales use a T-score metric interpret results. The mean score for a relevant reference population (United States general population) is 50 and 10 is the standard deviation of the population. T-score range is 20 to 80. A score of 40 is one standard deviation lower than the reference population mean and 60 is one standard deviation higher than the reference population mean. Higher scores indicate worse symptoms.
Outcome measures
| Measure |
Discontinuation of TKI Medication
n=172 Participants
Patients with CML on treatment with imatinib, dasatinib, nilotinib, or bosutinib and are in confirmed deep molecular response will stop their TKI. Confirmed deep (\> 4 log reduction) molecular response (\>MR4) defined as p210 (bcr-abl) fusion protein (BCR-ABL) \< 0.01%, for at least two years.
Concurrently, the study will assess a wide range of PROs before stopping TKIs and after discontinuation in conjunction with PCR testing, though at fewer time points, utilizing online and/or phone questionnaires.
|
|---|---|
|
Patient-reported Health Status Related to Sleep Status of Patients at 6 Months (After Stopping Tyrosine Kinase Inhibitors (TKIs)
|
48.3 T-Score
Standard Deviation 9.6
|
Adverse Events
Discontinuation of TKI Medication
Serious adverse events
| Measure |
Discontinuation of TKI Medication
n=173 participants at risk
Patients with CML on treatment with imatinib, dasatinib, nilotinib, or bosutinib and are in confirmed deep molecular response will stop their TKI. Confirmed deep (\> 4 log reduction) molecular response (\>MR4) defined as p210 (bcr-abl) fusion protein (BCR-ABL) \< 0.01%, for at least two years.
Concurrently, the study will assess a wide range of PROs before stopping TKIs and after discontinuation in conjunction with PCR testing, though at fewer time points, utilizing online and/or phone questionnaires.
|
|---|---|
|
Psychiatric disorders
Suicide attempt
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Nervous system disorders
Stroke
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
General disorders
Death, cause not specified
|
1.2%
2/173 • Number of events 2 • 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease progression
|
0.58%
1/173 • Number of events 1 • 4 years
|
Other adverse events
| Measure |
Discontinuation of TKI Medication
n=173 participants at risk
Patients with CML on treatment with imatinib, dasatinib, nilotinib, or bosutinib and are in confirmed deep molecular response will stop their TKI. Confirmed deep (\> 4 log reduction) molecular response (\>MR4) defined as p210 (bcr-abl) fusion protein (BCR-ABL) \< 0.01%, for at least two years.
Concurrently, the study will assess a wide range of PROs before stopping TKIs and after discontinuation in conjunction with PCR testing, though at fewer time points, utilizing online and/or phone questionnaires.
|
|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Ear and labyrinth disorders
Tinnitus
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Eye disorders
Eye disorders - Other, specify
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Eye disorders
Watering eyes
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Constipation
|
2.9%
5/173 • Number of events 5 • 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
4.6%
8/173 • Number of events 8 • 4 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Nausea
|
4.0%
7/173 • Number of events 7 • 4 years
|
|
General disorders
Edema limbs
|
5.2%
9/173 • Number of events 9 • 4 years
|
|
General disorders
Fatigue
|
11.6%
20/173 • Number of events 20 • 4 years
|
|
General disorders
Night sweats
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
General disorders
Gout
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
General disorders
Localized edema
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
General disorders
Malaise
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
General disorders
Pain
|
4.0%
7/173 • Number of events 7 • 4 years
|
|
Infections and infestations
Bladder infection
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Infections and infestations
Otitis media
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Infections and infestations
Pharyngitis
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Infections and infestations
Urinary tract infection
|
1.7%
3/173 • Number of events 3 • 4 years
|
|
Injury, poisoning and procedural complications
Bruising
|
1.2%
2/173 • Number of events 2 • 4 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Investigations
Alanine aminotransferase increased
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Investigations
Blood bilirubin increased
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Investigations
Cholesterol high
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Investigations
Creatinine increased
|
2.3%
4/173 • Number of events 4 • 4 years
|
|
Investigations
Investigations - Other, specify
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Investigations
Platelet count decreased
|
1.2%
2/173 • Number of events 2 • 4 years
|
|
Investigations
Weight gain
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Investigations
Weight loss
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Investigations
White blood cell decreased
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.0%
7/173 • Number of events 7 • 4 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
1.2%
2/173 • Number of events 2 • 4 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.7%
3/173 • Number of events 3 • 4 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
23/173 • Number of events 23 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.6%
8/173 • Number of events 8 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.5%
6/173 • Number of events 6 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
5.2%
9/173 • Number of events 9 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.7%
15/173 • Number of events 15 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.2%
9/173 • Number of events 9 • 4 years
|
|
Nervous system disorders
Concentration impairment
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Nervous system disorders
Dizziness
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Nervous system disorders
Dysgeusia
|
2.9%
5/173 • Number of events 5 • 4 years
|
|
Nervous system disorders
Headache
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Nervous system disorders
Paresthesia
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Nervous system disorders
Syncope
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Nervous system disorders
Transient ischemic attacks
|
3.5%
6/173 • Number of events 6 • 4 years
|
|
Psychiatric disorders
Anxiety
|
1.7%
3/173 • Number of events 3 • 4 years
|
|
Psychiatric disorders
Delirium
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Psychiatric disorders
Depression
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Psychiatric disorders
Insomnia
|
4.6%
8/173 • Number of events 8 • 4 years
|
|
Renal and urinary disorders
Urinary frequency
|
1.7%
3/173 • Number of events 3 • 4 years
|
|
Renal and urinary disorders
Urinary tract pain
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.7%
3/173 • Number of events 3 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
3/173 • Number of events 3 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.2%
2/173 • Number of events 2 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.7%
3/173 • Number of events 3 • 4 years
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.58%
1/173 • Number of events 1 • 4 years
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
1.7%
3/173 • Number of events 3 • 4 years
|
|
Vascular disorders
Hot flashes
|
1.7%
3/173 • Number of events 3 • 4 years
|
|
Vascular disorders
Hypertension
|
1.7%
3/173 • Number of events 3 • 4 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place