Trial Outcomes & Findings for Sapanisertib in Treating Patients With Metastatic or Refractory Pancreatic Neuroendocrine Tumor That Cannot Be Removed by Surgery (NCT NCT02893930)
NCT ID: NCT02893930
Last Updated: 2023-10-17
Results Overview
Response includes complete response (CR) and partial response (PR). CR is defined as disappearance of all lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Assessed every 3 months for the first 2 years, every 6 months for the 3rd year, then annually up to 5 years
Results posted on
2023-10-17
Participant Flow
This study activated on February 1, 2017 and was suspended on November 5, 2018 because the required pre-determined number of patients (n=13) had entered for the first stage response evaluation. The accrual of this trial was formally closed on December 27, 2019 as no response had been observed after the first stage accrual.
Participant milestones
| Measure |
Arm A (MLN0128)
Patients receive MLN0128 orally (PO) daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
Eligible and Treated
|
12
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Arm A (MLN0128)
Patients receive MLN0128 orally (PO) daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Death
|
1
|
|
Overall Study
Disease progression
|
5
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Ineligible
|
1
|
Baseline Characteristics
Sapanisertib in Treating Patients With Metastatic or Refractory Pancreatic Neuroendocrine Tumor That Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Arm A (MLN0128)
n=12 Participants
Patients receive MLN0128 orally (PO) daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
62.5 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Assessed every 3 months for the first 2 years, every 6 months for the 3rd year, then annually up to 5 yearsPopulation: Eligible and treated patients
Response includes complete response (CR) and partial response (PR). CR is defined as disappearance of all lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Arm A (MLN0128)
n=12 Participants
Patients receive MLN0128 orally (PO) daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Response Rate
|
0 proportion of participants
Interval 0.0 to 0.26
|
SECONDARY outcome
Timeframe: Assessed every 3 months for 2 years, every 6 months for the 3rd year, then annually up to 5 yearsPopulation: Eligible and treated patients
PFS was defined as time from study registration to disease progression (as defined by the RECIST criteria) or to death without progression, whichever occurred first. If date of death was greater than 4 months after the date of last documented to be free of progression or if patients were alive and free of progression at the time of the analysis, patients were censored at the time of last disease assessment. If such a date was not available, patients were censored at the time of registration. 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. The appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions is also considered progression.
Outcome measures
| Measure |
Arm A (MLN0128)
n=12 Participants
Patients receive MLN0128 orally (PO) daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Progression-free Survival (PFS)
|
5.19 months
Interval 3.84 to 9.3
|
SECONDARY outcome
Timeframe: Assessed every 3 months for 2 years, every 6 months for the 3rd year, then annually up to 5 yearsPopulation: Eligible and treated patients
Disease control rate was defined as the proportion of patients with best overall response of CR, PR, or stable disease (SD) among all eligible patients who started protocol treatment. CR is defined as disappearance of all lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval of 8 weeks.
Outcome measures
| Measure |
Arm A (MLN0128)
n=12 Participants
Patients receive MLN0128 orally (PO) daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Disease Control Rate
|
0.67 proportion of participants
Interval 0.35 to 0.9
|
SECONDARY outcome
Timeframe: Assessed every 3 months for 2 years, every 6 months for the 3rd year, then annually up to 5 yearsPopulation: Only patients who achieved a response (CR or PR) are included in the analysis of duration of response. No patients on this study had a response (CR or PR).
Duration of response was defined as the time from the onset of response (CR or PR, whichever status was recorded first) to first documentation of disease progression. Patients with responses but without documented disease progression were censored at the time of last disease evaluation. CR is defined as disappearance of all lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Disease 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. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions is also considered progression.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (MLN0128)
Serious events: 7 serious events
Other events: 13 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Arm A (MLN0128)
n=13 participants at risk
Patients receive MLN0128 orally (PO) daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
General disorders
Fatigue
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Gastrointestinal disorders
Diarrhea
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Investigations
Lymphocyte count decreased
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
23.1%
3/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
Other adverse events
| Measure |
Arm A (MLN0128)
n=13 participants at risk
Patients receive MLN0128 orally (PO) daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
15.4%
2/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
General disorders
Edema limbs
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
General disorders
Fatigue
|
30.8%
4/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
General disorders
Non-cardiac chest pain
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.4%
2/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
23.1%
3/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.4%
2/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Gastrointestinal disorders
Diarrhea
|
30.8%
4/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Gastrointestinal disorders
Hemorrhoids
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Gastrointestinal disorders
Mucositis oral
|
46.2%
6/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Gastrointestinal disorders
Nausea
|
46.2%
6/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Investigations
Alkaline phosphatase increased
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Investigations
Cholesterol high
|
15.4%
2/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Investigations
Neutrophil count decreased
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Investigations
Platelet count decreased
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Investigations
Weight loss
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Investigations
White blood cell decreased
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Metabolism and nutrition disorders
Anorexia
|
15.4%
2/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
69.2%
9/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, spe
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Eye disorders
Dry eye
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Eye disorders
Eye disorders - Other, specify
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Renal and urinary disorders
Proteinuria
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Renal and urinary disorders
Urinary tract pain
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
|
Vascular disorders
Hypertension
|
7.7%
1/13 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Serious adverse events are defined as those adverse events of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other adverse events are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60