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2020-05-05 00:00:00
2026-09-08 00:00:00
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NCT04761055
primary
0
Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results
diagnostic_accuracy
diagnostic_accuracy
null
unspecified
false
false
0.72
approximately one month after imaging scan
null
null
null
false
0
null
INTERVENTIONAL
COMPLETED
true
300
ACTUAL
Breast Screening
Breast Screening
OTHER; DEVICE; DIAGNOSTIC_TEST
Clinical Breast exam (CBE); iBreastExam device; mammogram
Memorial Sloan Kettering Cancer Center
OTHER
2021-01-29
2025-08-19
2026-07-30
null
NONE
DIAGNOSTIC
NCT04761055
primary
1
Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results
diagnostic_accuracy
diagnostic_accuracy
null
unspecified
false
false
0.72
approximately one month after imaging scan
null
null
null
false
0
null
INTERVENTIONAL
COMPLETED
true
300
ACTUAL
Breast Screening
Breast Screening
OTHER; DEVICE; DIAGNOSTIC_TEST
Clinical Breast exam (CBE); iBreastExam device; mammogram
Memorial Sloan Kettering Cancer Center
OTHER
2021-01-29
2025-08-19
2026-07-30
null
NONE
DIAGNOSTIC
NCT05823948
primary
0
Change in Glycosylated Haemoglobin (HbA1c)
biomarker_laboratory
change_from_baseline
hba1c_change
lower_is_better
true
false
1
Baseline (week 0), week 26
null
null
null
true
0
PHASE3
INTERVENTIONAL
COMPLETED
true
51
ACTUAL
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 2
DRUG
Insulin Icodec
Novo Nordisk A/S
INDUSTRY
2023-04-11
2024-04-11
2026-04-30
null
NONE
TREATMENT
NCT05381948
primary
0
Average Change in Best Corrected Visual Acuity (BCVA) From Baseline Averaged Over Weeks 28 and 32
unclassified
change_from_baseline
null
unspecified
false
false
0.36
Baseline (Day 1) and Weeks 28 and 32
null
null
null
true
0
PHASE2
INTERVENTIONAL
COMPLETED
true
161
ACTUAL
Wet Age-related Macular Degeneration
Wet Age-related Macular Degeneration
DRUG; DRUG
EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph
EyePoint Pharmaceuticals, Inc.
INDUSTRY
2022-06-30
2024-04-24
2025-10-02
RANDOMIZED
TRIPLE
TREATMENT
NCT05381948
secondary
0
Change From Baseline in Best Corrected Visual Acuity up to Week 56
unclassified
change_from_baseline
null
unspecified
false
false
0.36
Baseline (Day 1) and Weeks 32 and 56
null
null
null
true
0
PHASE2
INTERVENTIONAL
COMPLETED
true
161
ACTUAL
Wet Age-related Macular Degeneration
Wet Age-related Macular Degeneration
DRUG; DRUG
EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph
EyePoint Pharmaceuticals, Inc.
INDUSTRY
2022-06-30
2024-04-24
2025-10-02
RANDOMIZED
TRIPLE
TREATMENT
NCT05381948
secondary
1
Percentage of Subjects With >=5, >=10, and >=15 BCVA Letter Change From Baseline up to Week 56
unclassified
change_from_baseline
null
unspecified
false
false
0.36
Baseline (Day 1) and Weeks 32 and 56
null
null
null
true
0
PHASE2
INTERVENTIONAL
COMPLETED
true
161
ACTUAL
Wet Age-related Macular Degeneration
Wet Age-related Macular Degeneration
DRUG; DRUG
EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph
EyePoint Pharmaceuticals, Inc.
INDUSTRY
2022-06-30
2024-04-24
2025-10-02
RANDOMIZED
TRIPLE
TREATMENT
NCT05381948
secondary
2
Percentage of Subjects Not Receiving Supplemental Injection of Aflibercept up to Week 56
unclassified
proportion
null
unspecified
false
false
0.34
Weeks 32 and 56
null
null
null
false
0
PHASE2
INTERVENTIONAL
COMPLETED
true
161
ACTUAL
Wet Age-related Macular Degeneration
Wet Age-related Macular Degeneration
DRUG; DRUG
EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph
EyePoint Pharmaceuticals, Inc.
INDUSTRY
2022-06-30
2024-04-24
2025-10-02
RANDOMIZED
TRIPLE
TREATMENT
NCT05381948
secondary
3
Median Time to First Supplemental Aflibercept Injection in the Study Eye Following the EYP-1901 Dose at Week 8
unclassified
time_to_event
null
unspecified
false
false
0.368
From Week 8 to Week 56
null
null
null
false
0
PHASE2
INTERVENTIONAL
COMPLETED
true
161
ACTUAL
Wet Age-related Macular Degeneration
Wet Age-related Macular Degeneration
DRUG; DRUG
EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph
EyePoint Pharmaceuticals, Inc.
INDUSTRY
2022-06-30
2024-04-24
2025-10-02
RANDOMIZED
TRIPLE
TREATMENT
NCT05381948
secondary
4
Number of Aflibercept Intravitreal Injections up to Week 56 (Including Loading Dose)
unclassified
count
null
unspecified
false
false
0.32
Weeks 32 and 56
null
null
null
false
0
PHASE2
INTERVENTIONAL
COMPLETED
true
161
ACTUAL
Wet Age-related Macular Degeneration
Wet Age-related Macular Degeneration
DRUG; DRUG
EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph
EyePoint Pharmaceuticals, Inc.
INDUSTRY
2022-06-30
2024-04-24
2025-10-02
RANDOMIZED
TRIPLE
TREATMENT
NCT05381948
secondary
5
Mean Change From Baseline in Central Subfield Thickness (CST) by Spectral-Domain - Optical Coherence Tomography (SD-OCT) up to Week 56
unclassified
change_from_baseline
null
unspecified
false
false
0.36
Baseline (Day 1) and Weeks 32 and 56
null
null
null
true
0
PHASE2
INTERVENTIONAL
COMPLETED
true
161
ACTUAL
Wet Age-related Macular Degeneration
Wet Age-related Macular Degeneration
DRUG; DRUG
EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph
EyePoint Pharmaceuticals, Inc.
INDUSTRY
2022-06-30
2024-04-24
2025-10-02
RANDOMIZED
TRIPLE
TREATMENT
NCT05381948
secondary
6
Change From Baseline in Height of Subretinal Fluid by Spectral-Domain - Optical Coherence Tomography up to Week 56
unclassified
change_from_baseline
null
unspecified
false
false
0.36
Baseline (Day 1) and Weeks 32 and 56
null
null
null
true
0
PHASE2
INTERVENTIONAL
COMPLETED
true
161
ACTUAL
Wet Age-related Macular Degeneration
Wet Age-related Macular Degeneration
DRUG; DRUG
EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph
EyePoint Pharmaceuticals, Inc.
INDUSTRY
2022-06-30
2024-04-24
2025-10-02
RANDOMIZED
TRIPLE
TREATMENT
NCT05381948
secondary
7
Percentage of Subjects With No Detectable Intraretinal Fluid/Cysts in the Central Subfield up to Week 56
unclassified
proportion
null
unspecified
false
false
0.34
Weeks 32 and 56
null
null
null
false
0
PHASE2
INTERVENTIONAL
COMPLETED
true
161
ACTUAL
Wet Age-related Macular Degeneration
Wet Age-related Macular Degeneration
DRUG; DRUG
EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph
EyePoint Pharmaceuticals, Inc.
INDUSTRY
2022-06-30
2024-04-24
2025-10-02
RANDOMIZED
TRIPLE
TREATMENT
NCT05381948
secondary
8
Change From Baseline in Total Lesion Area by Fluorescein Angiography (FA) up to Week 56
unclassified
change_from_baseline
null
unspecified
false
false
0.36
Baseline (Day 1) and Weeks 32 and 56
null
null
null
true
0
PHASE2
INTERVENTIONAL
COMPLETED
true
161
ACTUAL
Wet Age-related Macular Degeneration
Wet Age-related Macular Degeneration
DRUG; DRUG
EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph
EyePoint Pharmaceuticals, Inc.
INDUSTRY
2022-06-30
2024-04-24
2025-10-02
RANDOMIZED
TRIPLE
TREATMENT
NCT05381948
secondary
9
Change From Baseline in Total Choroidal Neovascularization Area by Fluorescein Angiography up to Week 56
unclassified
change_from_baseline
null
unspecified
false
false
0.36
Baseline (Day 1) and Weeks 32 and 56
null
null
null
true
0
PHASE2
INTERVENTIONAL
COMPLETED
true
161
ACTUAL
Wet Age-related Macular Degeneration
Wet Age-related Macular Degeneration
DRUG; DRUG
EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph
EyePoint Pharmaceuticals, Inc.
INDUSTRY
2022-06-30
2024-04-24
2025-10-02
RANDOMIZED
TRIPLE
TREATMENT
NCT05381948
secondary
10
Systemic Exposure to EYP-1901 Measured Through Plasma Levels up to Week 56
biomarker_laboratory
concentration
null
unspecified
false
false
0.6
Up to Week 56
null
null
null
false
0
PHASE2
INTERVENTIONAL
COMPLETED
true
161
ACTUAL
Wet Age-related Macular Degeneration
Wet Age-related Macular Degeneration
DRUG; DRUG
EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph
EyePoint Pharmaceuticals, Inc.
INDUSTRY
2022-06-30
2024-04-24
2025-10-02
RANDOMIZED
TRIPLE
TREATMENT
NCT05381948
secondary
11
Ocular Exposure to EYP-1901 Measured Through Aqueous Humor (AH) Levels up to Week 32
unclassified
concentration
null
unspecified
false
false
0.28
Up to Week 32
null
null
null
false
0
PHASE2
INTERVENTIONAL
COMPLETED
true
161
ACTUAL
Wet Age-related Macular Degeneration
Wet Age-related Macular Degeneration
DRUG; DRUG
EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph
EyePoint Pharmaceuticals, Inc.
INDUSTRY
2022-06-30
2024-04-24
2025-10-02
RANDOMIZED
TRIPLE
TREATMENT
NCT05381948
secondary
12
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Treatment-Emergent Adverse Events up to Week 56
safety
count
adverse_event_incidence
lower_is_better
true
false
0.96
From the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
392
1
false
false
0.9
PHASE2
INTERVENTIONAL
COMPLETED
true
161
ACTUAL
Wet Age-related Macular Degeneration
Wet Age-related Macular Degeneration
DRUG; DRUG
EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph
EyePoint Pharmaceuticals, Inc.
INDUSTRY
2022-06-30
2024-04-24
2025-10-02
RANDOMIZED
TRIPLE
TREATMENT
NCT04050540
primary
0
Incidence of N. Gonorrhoeae, C. Trachomatis, or Early Syphilis Infection by Laboratory-based Diagnosis
immunogenicity
proportion
null
lower_is_better
false
false
0.7
12 months post enrolment
365.28
1
false
false
0.9
PHASE4
INTERVENTIONAL
COMPLETED
true
449
ACTUAL
HIV Infections
HIV Infections; HIV/AIDS; Neisseria Gonorrheae Infection; Chlamydia Trachomatis Infection; Syphilis Infection
DRUG
Doxycycline
University of Washington
OTHER
2020-02-05
2022-10-30
2024-07-10
RANDOMIZED
NONE
PREVENTION
NCT04810091
primary
0
Percent Change in NTproBNP at 6 Months Visit From Baseline
unclassified
change_from_baseline
null
unspecified
false
false
0.36
Baseline and at 6 months
182.64
1
false
true
0.9
PHASE3
INTERVENTIONAL
ACTIVE_NOT_RECRUITING
true
79
ACTUAL
Locally Advanced Neuroendocrine Neoplasm
Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm
DRUG; OTHER; DRUG
Placebo Administration; Questionnaire Administration; Telotristat Ethyl
M.D. Anderson Cancer Center
OTHER
2021-05-18
2026-08-03
2026-02-05
RANDOMIZED
NONE
TREATMENT
NCT04810091
secondary
0
Change in 6MWT at 3 Month Visit
behavioral_functional
change_from_baseline
null
unspecified
false
false
0.672
Baseline and 3 month follow-up
91.32
1
false
true
0.9
PHASE3
INTERVENTIONAL
ACTIVE_NOT_RECRUITING
true
79
ACTUAL
Locally Advanced Neuroendocrine Neoplasm
Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm
DRUG; OTHER; DRUG
Placebo Administration; Questionnaire Administration; Telotristat Ethyl
M.D. Anderson Cancer Center
OTHER
2021-05-18
2026-08-03
2026-02-05
RANDOMIZED
NONE
TREATMENT
NCT04810091
secondary
1
Change in 6MWT at 6 Month Visit
behavioral_functional
change_from_baseline
null
unspecified
false
false
0.672
Baseline and 6 month follow-up
182.64
1
false
true
0.9
PHASE3
INTERVENTIONAL
ACTIVE_NOT_RECRUITING
true
79
ACTUAL
Locally Advanced Neuroendocrine Neoplasm
Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm
DRUG; OTHER; DRUG
Placebo Administration; Questionnaire Administration; Telotristat Ethyl
M.D. Anderson Cancer Center
OTHER
2021-05-18
2026-08-03
2026-02-05
RANDOMIZED
NONE
TREATMENT
NCT04810091
secondary
2
Change in CVHD % Score From Baseline to 3 Month Visit
efficacy
change_from_baseline
null
ambiguous
false
false
0.66
Baseline and 3 month follow-up
91.32
1
false
true
0.9
PHASE3
INTERVENTIONAL
ACTIVE_NOT_RECRUITING
true
79
ACTUAL
Locally Advanced Neuroendocrine Neoplasm
Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm
DRUG; OTHER; DRUG
Placebo Administration; Questionnaire Administration; Telotristat Ethyl
M.D. Anderson Cancer Center
OTHER
2021-05-18
2026-08-03
2026-02-05
RANDOMIZED
NONE
TREATMENT
NCT04810091
secondary
3
Change in CVHD Score From Baseline to 6 Month Visit
efficacy
change_from_baseline
null
ambiguous
false
false
0.66
Baseline and 6 month follow-up
182.64
1
false
true
0.9
PHASE3
INTERVENTIONAL
ACTIVE_NOT_RECRUITING
true
79
ACTUAL
Locally Advanced Neuroendocrine Neoplasm
Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm
DRUG; OTHER; DRUG
Placebo Administration; Questionnaire Administration; Telotristat Ethyl
M.D. Anderson Cancer Center
OTHER
2021-05-18
2026-08-03
2026-02-05
RANDOMIZED
NONE
TREATMENT
NCT04810091
secondary
4
Percentage of Participants With Significant Change in Strain-RV From Baseline at 3 Months
unclassified
change_from_baseline
null
unspecified
false
false
0.36
Baseline and 3 month follow-up
91.32
1
false
true
0.9
PHASE3
INTERVENTIONAL
ACTIVE_NOT_RECRUITING
true
79
ACTUAL
Locally Advanced Neuroendocrine Neoplasm
Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm
DRUG; OTHER; DRUG
Placebo Administration; Questionnaire Administration; Telotristat Ethyl
M.D. Anderson Cancer Center
OTHER
2021-05-18
2026-08-03
2026-02-05
RANDOMIZED
NONE
TREATMENT
NCT04810091
secondary
5
Percentage of Participants With Significant Change in Strain-RV From Baseline at 6 Months
unclassified
change_from_baseline
null
unspecified
false
false
0.36
Baseline and 6 month follow-up
182.64
1
false
true
0.9
PHASE3
INTERVENTIONAL
ACTIVE_NOT_RECRUITING
true
79
ACTUAL
Locally Advanced Neuroendocrine Neoplasm
Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm
DRUG; OTHER; DRUG
Placebo Administration; Questionnaire Administration; Telotristat Ethyl
M.D. Anderson Cancer Center
OTHER
2021-05-18
2026-08-03
2026-02-05
RANDOMIZED
NONE
TREATMENT
NCT04810091
secondary
6
Percentage of Participants With Significant Change in Strain-LV From Baseline at 3 Months
unclassified
change_from_baseline
null
unspecified
false
false
0.36
Baseline and 3 month follow-up
91.32
1
false
true
0.9
PHASE3
INTERVENTIONAL
ACTIVE_NOT_RECRUITING
true
79
ACTUAL
Locally Advanced Neuroendocrine Neoplasm
Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm
DRUG; OTHER; DRUG
Placebo Administration; Questionnaire Administration; Telotristat Ethyl
M.D. Anderson Cancer Center
OTHER
2021-05-18
2026-08-03
2026-02-05
RANDOMIZED
NONE
TREATMENT
NCT04810091
secondary
7
Percentage of Participants With Significant Change in Strain-LV From Baseline at 6 Months
unclassified
change_from_baseline
null
unspecified
false
false
0.36
Baseline and 6 month follow-up
182.64
1
false
true
0.9
PHASE3
INTERVENTIONAL
ACTIVE_NOT_RECRUITING
true
79
ACTUAL
Locally Advanced Neuroendocrine Neoplasm
Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm
DRUG; OTHER; DRUG
Placebo Administration; Questionnaire Administration; Telotristat Ethyl
M.D. Anderson Cancer Center
OTHER
2021-05-18
2026-08-03
2026-02-05
RANDOMIZED
NONE
TREATMENT
NCT04810091
secondary
8
Percentage of Participants With Normal TAPSE at 3 Months
clinical_assessment
proportion
blood_pressure
unspecified
true
false
0.98
3 month follow-up
91.32
1
false
false
0.9
PHASE3
INTERVENTIONAL
ACTIVE_NOT_RECRUITING
true
79
ACTUAL
Locally Advanced Neuroendocrine Neoplasm
Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm
DRUG; OTHER; DRUG
Placebo Administration; Questionnaire Administration; Telotristat Ethyl
M.D. Anderson Cancer Center
OTHER
2021-05-18
2026-08-03
2026-02-05
RANDOMIZED
NONE
TREATMENT
NCT04810091
secondary
9
Percentage of Participants With Normal TAPSE at 6 Months
clinical_assessment
proportion
blood_pressure
unspecified
true
false
0.98
6 month follow-up
182.64
1
false
false
0.9
PHASE3
INTERVENTIONAL
ACTIVE_NOT_RECRUITING
true
79
ACTUAL
Locally Advanced Neuroendocrine Neoplasm
Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm
DRUG; OTHER; DRUG
Placebo Administration; Questionnaire Administration; Telotristat Ethyl
M.D. Anderson Cancer Center
OTHER
2021-05-18
2026-08-03
2026-02-05
RANDOMIZED
NONE
TREATMENT
NCT04810091
secondary
10
Change in 5HIAA From Baseline to 3 Months
biomarker_laboratory
change_from_baseline
null
unspecified
false
false
0.68
Baseline and 3 month follow-up
91.32
1
false
true
0.9
PHASE3
INTERVENTIONAL
ACTIVE_NOT_RECRUITING
true
79
ACTUAL
Locally Advanced Neuroendocrine Neoplasm
Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm
DRUG; OTHER; DRUG
Placebo Administration; Questionnaire Administration; Telotristat Ethyl
M.D. Anderson Cancer Center
OTHER
2021-05-18
2026-08-03
2026-02-05
RANDOMIZED
NONE
TREATMENT
NCT04810091
secondary
11
Change in 5HIAA From Baseline to 6 Months
unclassified
change_from_baseline
null
unspecified
false
false
0.36
Baseline and 6 month follow-up
182.64
1
false
true
0.9
PHASE3
INTERVENTIONAL
ACTIVE_NOT_RECRUITING
true
79
ACTUAL
Locally Advanced Neuroendocrine Neoplasm
Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm
DRUG; OTHER; DRUG
Placebo Administration; Questionnaire Administration; Telotristat Ethyl
M.D. Anderson Cancer Center
OTHER
2021-05-18
2026-08-03
2026-02-05
RANDOMIZED
NONE
TREATMENT
NCT04810091
secondary
12
Change in Troponin From Baseline to 3 Months
unclassified
change_from_baseline
null
unspecified
false
false
0.36
Baseline and 3 months follow-up
91.32
1
false
true
0.9
PHASE3
INTERVENTIONAL
ACTIVE_NOT_RECRUITING
true
79
ACTUAL
Locally Advanced Neuroendocrine Neoplasm
Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm
DRUG; OTHER; DRUG
Placebo Administration; Questionnaire Administration; Telotristat Ethyl
M.D. Anderson Cancer Center
OTHER
2021-05-18
2026-08-03
2026-02-05
RANDOMIZED
NONE
TREATMENT
NCT04810091
secondary
13
Change in Troponin From Baseline to 6 Months
unclassified
change_from_baseline
null
unspecified
false
false
0.36
Baseline and 6 months follow-up
182.64
1
false
true
0.9
PHASE3
INTERVENTIONAL
ACTIVE_NOT_RECRUITING
true
79
ACTUAL
Locally Advanced Neuroendocrine Neoplasm
Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm
DRUG; OTHER; DRUG
Placebo Administration; Questionnaire Administration; Telotristat Ethyl
M.D. Anderson Cancer Center
OTHER
2021-05-18
2026-08-03
2026-02-05
RANDOMIZED
NONE
TREATMENT
NCT04810091
secondary
14
Change in MDASI Mean Core Symptom Score From Baseline to 3 Months
unclassified
change_from_baseline
null
lower_is_better
false
false
0.36
Baseline and 3 months follow-up
91.32
1
false
true
0.9
PHASE3
INTERVENTIONAL
ACTIVE_NOT_RECRUITING
true
79
ACTUAL
Locally Advanced Neuroendocrine Neoplasm
Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm
DRUG; OTHER; DRUG
Placebo Administration; Questionnaire Administration; Telotristat Ethyl
M.D. Anderson Cancer Center
OTHER
2021-05-18
2026-08-03
2026-02-05
RANDOMIZED
NONE
TREATMENT
NCT04810091
secondary
15
Change in Core Symptom Score From Baseline to 6 Months
unclassified
change_from_baseline
null
lower_is_better
false
false
0.36
Baseline and 6 months follow-up
182.64
1
false
true
0.9
PHASE3
INTERVENTIONAL
ACTIVE_NOT_RECRUITING
true
79
ACTUAL
Locally Advanced Neuroendocrine Neoplasm
Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm
DRUG; OTHER; DRUG
Placebo Administration; Questionnaire Administration; Telotristat Ethyl
M.D. Anderson Cancer Center
OTHER
2021-05-18
2026-08-03
2026-02-05
RANDOMIZED
NONE
TREATMENT
NCT04810091
secondary
16
Change in MDASI Mean Total Symptom Score From Baseline to 3 Months
unclassified
change_from_baseline
null
lower_is_better
false
false
0.36
Baseline and 3 months follow-up
91.32
1
false
true
0.9
PHASE3
INTERVENTIONAL
ACTIVE_NOT_RECRUITING
true
79
ACTUAL
Locally Advanced Neuroendocrine Neoplasm
Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm
DRUG; OTHER; DRUG
Placebo Administration; Questionnaire Administration; Telotristat Ethyl
M.D. Anderson Cancer Center
OTHER
2021-05-18
2026-08-03
2026-02-05
RANDOMIZED
NONE
TREATMENT
NCT04810091
secondary
17
Change in MDASI Mean Total Symptom Score From Baseline to 6 Months
unclassified
change_from_baseline
null
lower_is_better
false
false
0.36
Baseline and 6 months follow-up
182.64
1
false
true
0.9
PHASE3
INTERVENTIONAL
ACTIVE_NOT_RECRUITING
true
79
ACTUAL
Locally Advanced Neuroendocrine Neoplasm
Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm
DRUG; OTHER; DRUG
Placebo Administration; Questionnaire Administration; Telotristat Ethyl
M.D. Anderson Cancer Center
OTHER
2021-05-18
2026-08-03
2026-02-05
RANDOMIZED
NONE
TREATMENT
NCT04810091
secondary
18
Change in MDASI Mean Interference Score From Baseline to 3 Months
unclassified
change_from_baseline
null
lower_is_better
false
false
0.36
Baseline and 3 months follow-up
91.32
1
false
true
0.9
PHASE3
INTERVENTIONAL
ACTIVE_NOT_RECRUITING
true
79
ACTUAL
Locally Advanced Neuroendocrine Neoplasm
Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm
DRUG; OTHER; DRUG
Placebo Administration; Questionnaire Administration; Telotristat Ethyl
M.D. Anderson Cancer Center
OTHER
2021-05-18
2026-08-03
2026-02-05
RANDOMIZED
NONE
TREATMENT
NCT04810091
secondary
19
Change in Interference Score From Baseline to 6 Months
unclassified
change_from_baseline
null
lower_is_better
false
false
0.36
Baseline and 6 months follow-up
182.64
1
false
true
0.9
PHASE3
INTERVENTIONAL
ACTIVE_NOT_RECRUITING
true
79
ACTUAL
Locally Advanced Neuroendocrine Neoplasm
Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm
DRUG; OTHER; DRUG
Placebo Administration; Questionnaire Administration; Telotristat Ethyl
M.D. Anderson Cancer Center
OTHER
2021-05-18
2026-08-03
2026-02-05
RANDOMIZED
NONE
TREATMENT
NCT04810091
secondary
20
Compliance>=70% While the Patients Were in the Study
healthcare_utilization
proportion
null
unspecified
false
false
0.66
Baseline, 3 months follow-up, 6 months follow-up
182.64
2
true
true
0.65
PHASE3
INTERVENTIONAL
ACTIVE_NOT_RECRUITING
true
79
ACTUAL
Locally Advanced Neuroendocrine Neoplasm
Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm
DRUG; OTHER; DRUG
Placebo Administration; Questionnaire Administration; Telotristat Ethyl
M.D. Anderson Cancer Center
OTHER
2021-05-18
2026-08-03
2026-02-05
RANDOMIZED
NONE
TREATMENT
NCT04280562
primary
0
Change in Neuropathic Pain Symptom Inventory (NPSI)
unclassified
change_from_baseline
null
lower_is_better
false
false
0.36
Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
null
null
null
true
0
null
INTERVENTIONAL
COMPLETED
true
75
ACTUAL
Neuropathic Pain
Neuropathic Pain; Chronic Pain; Pain
DEVICE; DEVICE
Sana Pain Reliever; Sham SPR
Icahn School of Medicine at Mount Sinai
OTHER
2020-01-31
2023-02-21
2025-07-09
RANDOMIZED
DOUBLE
TREATMENT
NCT04280562
primary
1
Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 1: Burning Pain
unclassified
change_from_baseline
null
lower_is_better
false
false
0.36
Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
null
null
null
true
0
null
INTERVENTIONAL
COMPLETED
true
75
ACTUAL
Neuropathic Pain
Neuropathic Pain; Chronic Pain; Pain
DEVICE; DEVICE
Sana Pain Reliever; Sham SPR
Icahn School of Medicine at Mount Sinai
OTHER
2020-01-31
2023-02-21
2025-07-09
RANDOMIZED
DOUBLE
TREATMENT
NCT04280562
primary
2
Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 2: Pressing Pain
unclassified
change_from_baseline
null
lower_is_better
false
false
0.36
Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
null
null
null
true
0
null
INTERVENTIONAL
COMPLETED
true
75
ACTUAL
Neuropathic Pain
Neuropathic Pain; Chronic Pain; Pain
DEVICE; DEVICE
Sana Pain Reliever; Sham SPR
Icahn School of Medicine at Mount Sinai
OTHER
2020-01-31
2023-02-21
2025-07-09
RANDOMIZED
DOUBLE
TREATMENT
NCT04280562
primary
3
Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 3: Paroxysmal Pain
unclassified
change_from_baseline
null
lower_is_better
false
false
0.36
Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
null
null
null
true
0
null
INTERVENTIONAL
COMPLETED
true
75
ACTUAL
Neuropathic Pain
Neuropathic Pain; Chronic Pain; Pain
DEVICE; DEVICE
Sana Pain Reliever; Sham SPR
Icahn School of Medicine at Mount Sinai
OTHER
2020-01-31
2023-02-21
2025-07-09
RANDOMIZED
DOUBLE
TREATMENT
NCT04280562
primary
4
Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 4: Evoked Pain
unclassified
change_from_baseline
null
lower_is_better
false
false
0.36
Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
null
null
null
true
0
null
INTERVENTIONAL
COMPLETED
true
75
ACTUAL
Neuropathic Pain
Neuropathic Pain; Chronic Pain; Pain
DEVICE; DEVICE
Sana Pain Reliever; Sham SPR
Icahn School of Medicine at Mount Sinai
OTHER
2020-01-31
2023-02-21
2025-07-09
RANDOMIZED
DOUBLE
TREATMENT
NCT04280562
primary
5
Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 5: Paresthesia or Dysesthesia
unclassified
change_from_baseline
null
lower_is_better
false
false
0.36
Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
null
null
null
true
0
null
INTERVENTIONAL
COMPLETED
true
75
ACTUAL
Neuropathic Pain
Neuropathic Pain; Chronic Pain; Pain
DEVICE; DEVICE
Sana Pain Reliever; Sham SPR
Icahn School of Medicine at Mount Sinai
OTHER
2020-01-31
2023-02-21
2025-07-09
RANDOMIZED
DOUBLE
TREATMENT
NCT04280562
secondary
0
Change in Patient Health Questionnaire Type 9 for Depression (PHQ-9)
patient_reported
change_from_baseline
depression_score
lower_is_better
true
false
1
Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
null
null
null
true
0
null
INTERVENTIONAL
COMPLETED
true
75
ACTUAL
Neuropathic Pain
Neuropathic Pain; Chronic Pain; Pain
DEVICE; DEVICE
Sana Pain Reliever; Sham SPR
Icahn School of Medicine at Mount Sinai
OTHER
2020-01-31
2023-02-21
2025-07-09
RANDOMIZED
DOUBLE
TREATMENT
NCT04280562
secondary
1
Change in Pittsburgh Sleep Quality Index (PSQI)
behavioral_functional
change_from_baseline
null
unspecified
false
false
0.672
Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
null
null
null
true
0
null
INTERVENTIONAL
COMPLETED
true
75
ACTUAL
Neuropathic Pain
Neuropathic Pain; Chronic Pain; Pain
DEVICE; DEVICE
Sana Pain Reliever; Sham SPR
Icahn School of Medicine at Mount Sinai
OTHER
2020-01-31
2023-02-21
2025-07-09
RANDOMIZED
DOUBLE
TREATMENT
NCT04280562
secondary
2
Change in Beck Depression Inventory (BDI)
patient_reported
change_from_baseline
depression_score
lower_is_better
true
false
1
Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
null
null
null
true
0
null
INTERVENTIONAL
COMPLETED
true
75
ACTUAL
Neuropathic Pain
Neuropathic Pain; Chronic Pain; Pain
DEVICE; DEVICE
Sana Pain Reliever; Sham SPR
Icahn School of Medicine at Mount Sinai
OTHER
2020-01-31
2023-02-21
2025-07-09
RANDOMIZED
DOUBLE
TREATMENT
NCT04280562
secondary
3
Change in General Anxiety Disorder 7-item Questionnaire (GAD-7)
patient_reported
change_from_baseline
anxiety_score
lower_is_better
true
false
1
Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
null
null
null
true
0
null
INTERVENTIONAL
COMPLETED
true
75
ACTUAL
Neuropathic Pain
Neuropathic Pain; Chronic Pain; Pain
DEVICE; DEVICE
Sana Pain Reliever; Sham SPR
Icahn School of Medicine at Mount Sinai
OTHER
2020-01-31
2023-02-21
2025-07-09
RANDOMIZED
DOUBLE
TREATMENT
NCT04280562
secondary
4
Change in World Health Organization Quality of Life Pain (WHOQOL-pain) - Pain Facet
patient_reported
change_from_baseline
quality_of_life
ambiguous
true
false
1
Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
null
null
null
true
0
null
INTERVENTIONAL
COMPLETED
true
75
ACTUAL
Neuropathic Pain
Neuropathic Pain; Chronic Pain; Pain
DEVICE; DEVICE
Sana Pain Reliever; Sham SPR
Icahn School of Medicine at Mount Sinai
OTHER
2020-01-31
2023-02-21
2025-07-09
RANDOMIZED
DOUBLE
TREATMENT
NCT04280562
secondary
5
Change in World Health Organization Quality of Life Bref (WHOQOL-BREF)
patient_reported
change_from_baseline
quality_of_life
higher_is_better
true
false
1
Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
null
null
null
true
0
null
INTERVENTIONAL
COMPLETED
true
75
ACTUAL
Neuropathic Pain
Neuropathic Pain; Chronic Pain; Pain
DEVICE; DEVICE
Sana Pain Reliever; Sham SPR
Icahn School of Medicine at Mount Sinai
OTHER
2020-01-31
2023-02-21
2025-07-09
RANDOMIZED
DOUBLE
TREATMENT
NCT04280562
secondary
6
Change in Patient's Global Impression of Change (PGIC)
patient_reported
change_from_baseline
pain_score
ambiguous
true
false
1
Post-assessment (Week 10); Follow up (Week 14)
null
null
null
false
0
null
INTERVENTIONAL
COMPLETED
true
75
ACTUAL
Neuropathic Pain
Neuropathic Pain; Chronic Pain; Pain
DEVICE; DEVICE
Sana Pain Reliever; Sham SPR
Icahn School of Medicine at Mount Sinai
OTHER
2020-01-31
2023-02-21
2025-07-09
RANDOMIZED
DOUBLE
TREATMENT
NCT04280562
secondary
7
Visual Analogue Scale (VAS)-Pain
patient_reported
score_scale
pain_score
lower_is_better
true
false
0.96
before and after each time device used up to 14 weeks
98
1
false
false
0.9
null
INTERVENTIONAL
COMPLETED
true
75
ACTUAL
Neuropathic Pain
Neuropathic Pain; Chronic Pain; Pain
DEVICE; DEVICE
Sana Pain Reliever; Sham SPR
Icahn School of Medicine at Mount Sinai
OTHER
2020-01-31
2023-02-21
2025-07-09
RANDOMIZED
DOUBLE
TREATMENT
NCT04280562
secondary
8
Visual Analogue Scale (VAS)-Sleep
patient_reported
change_from_baseline
null
unspecified
false
false
0.7
first 3 days and 14 weeks
98
2
true
false
0.65
null
INTERVENTIONAL
COMPLETED
true
75
ACTUAL
Neuropathic Pain
Neuropathic Pain; Chronic Pain; Pain
DEVICE; DEVICE
Sana Pain Reliever; Sham SPR
Icahn School of Medicine at Mount Sinai
OTHER
2020-01-31
2023-02-21
2025-07-09
RANDOMIZED
DOUBLE
TREATMENT
NCT05004662
primary
0
Self-Reported 7-Day Point-Prevalence Smoking Abstinence
behavioral_functional
unclassified
null
unspecified
false
false
0.312
12 Month Follow-Up
365.28
1
false
false
0.9
null
INTERVENTIONAL
COMPLETED
true
502
ACTUAL
Smoking Cessation
Smoking Cessation
BEHAVIORAL; DRUG; BEHAVIORAL; DRUG
Smartphone-delivered automated treatment; Nicotine patch; Counseling; Nicotine lozenge
H. Lee Moffitt Cancer Center and Research Institute
OTHER
2021-12-01
2025-08-19
2026-08-04
RANDOMIZED
NONE
PREVENTION
NCT05004662
secondary
0
Biochemical Verification Via Salivary Cotinine
behavioral_functional
unclassified
null
unspecified
false
false
0.312
12 Month Follow-Up
365.28
1
false
false
0.9
null
INTERVENTIONAL
COMPLETED
true
502
ACTUAL
Smoking Cessation
Smoking Cessation
BEHAVIORAL; DRUG; BEHAVIORAL; DRUG
Smartphone-delivered automated treatment; Nicotine patch; Counseling; Nicotine lozenge
H. Lee Moffitt Cancer Center and Research Institute
OTHER
2021-12-01
2025-08-19
2026-08-04
RANDOMIZED
NONE
PREVENTION
NCT05004662
secondary
1
Self-Reported 24-Hour Point-Prevalence Smoking Abstinence
behavioral_functional
count
null
unspecified
false
false
0.632
12 Month Follow-Up
365.28
1
false
false
0.9
null
INTERVENTIONAL
COMPLETED
true
502
ACTUAL
Smoking Cessation
Smoking Cessation
BEHAVIORAL; DRUG; BEHAVIORAL; DRUG
Smartphone-delivered automated treatment; Nicotine patch; Counseling; Nicotine lozenge
H. Lee Moffitt Cancer Center and Research Institute
OTHER
2021-12-01
2025-08-19
2026-08-04
RANDOMIZED
NONE
PREVENTION
NCT05004662
secondary
2
Self-Reported 30-Day Point-Prevalence Smoking Abstinence
behavioral_functional
count
null
unspecified
false
false
0.632
12 Month Follow-Up
365.28
1
false
false
0.9
null
INTERVENTIONAL
COMPLETED
true
502
ACTUAL
Smoking Cessation
Smoking Cessation
BEHAVIORAL; DRUG; BEHAVIORAL; DRUG
Smartphone-delivered automated treatment; Nicotine patch; Counseling; Nicotine lozenge
H. Lee Moffitt Cancer Center and Research Institute
OTHER
2021-12-01
2025-08-19
2026-08-04
RANDOMIZED
NONE
PREVENTION
NCT04181762
primary
0
Percentage of Participants Achieving Complete Renal Response (CRR) at Week 52
biomarker_laboratory
proportion
null
unspecified
false
false
0.66
Baseline, Week 52
null
null
null
true
0
PHASE3
INTERVENTIONAL
TERMINATED
true
275
ACTUAL
Lupus Nephritis
Lupus Nephritis
DRUG; DRUG
secukinumab; Placebo
Novartis Pharmaceuticals
INDUSTRY
2020-07-07
2023-09-13
2024-10-10
RANDOMIZED
QUADRUPLE
TREATMENT
NCT04181762
secondary
0
Change From Baseline in 24-hour Urine Protein-to Creatinine Ratio (UPCR)
biomarker_laboratory
change_from_baseline
null
unspecified
false
false
0.68
Baseline, Week 52
null
null
null
true
0
PHASE3
INTERVENTIONAL
TERMINATED
true
275
ACTUAL
Lupus Nephritis
Lupus Nephritis
DRUG; DRUG
secukinumab; Placebo
Novartis Pharmaceuticals
INDUSTRY
2020-07-07
2023-09-13
2024-10-10
RANDOMIZED
QUADRUPLE
TREATMENT
NCT04181762
secondary
1
Percentage of Participants Achieving Partial Renal Response (PRR) at Week 52
efficacy
proportion
null
unspecified
false
false
0.64
Baseline, Week 52
null
null
null
true
0
PHASE3
INTERVENTIONAL
TERMINATED
true
275
ACTUAL
Lupus Nephritis
Lupus Nephritis
DRUG; DRUG
secukinumab; Placebo
Novartis Pharmaceuticals
INDUSTRY
2020-07-07
2023-09-13
2024-10-10
RANDOMIZED
QUADRUPLE
TREATMENT
NCT04181762
secondary
2
Average Daily Dose of Oral Corticosteroids
efficacy
unclassified
null
higher_is_better
false
false
0.3
Week 16 to Week 52
null
null
null
false
0
PHASE3
INTERVENTIONAL
TERMINATED
true
275
ACTUAL
Lupus Nephritis
Lupus Nephritis
DRUG; DRUG
secukinumab; Placebo
Novartis Pharmaceuticals
INDUSTRY
2020-07-07
2023-09-13
2024-10-10
RANDOMIZED
QUADRUPLE
TREATMENT
NCT04181762
secondary
3
Percentage of Participants Achieving Partial Renal Response (PRR) at Week 24
efficacy
proportion
null
unspecified
false
false
0.64
Baseline, Week 24
null
null
null
true
0
PHASE3
INTERVENTIONAL
TERMINATED
true
275
ACTUAL
Lupus Nephritis
Lupus Nephritis
DRUG; DRUG
secukinumab; Placebo
Novartis Pharmaceuticals
INDUSTRY
2020-07-07
2023-09-13
2024-10-10
RANDOMIZED
QUADRUPLE
TREATMENT
NCT04181762
secondary
4
Incidence Rate of Participants Achieving Complete Renal Response (CRR) up to Week 52
unclassified
time_to_event
null
unspecified
false
false
0.368
Baseline to Week 52
null
null
null
true
0
PHASE3
INTERVENTIONAL
TERMINATED
true
275
ACTUAL
Lupus Nephritis
Lupus Nephritis
DRUG; DRUG
secukinumab; Placebo
Novartis Pharmaceuticals
INDUSTRY
2020-07-07
2023-09-13
2024-10-10
RANDOMIZED
QUADRUPLE
TREATMENT
NCT04181762
secondary
5
Incidence Rate of Participants Achieving Partial Renal Response (PRR) up to Week 52
unclassified
time_to_event
null
unspecified
false
false
0.368
Baseline to Week 52
null
null
null
true
0
PHASE3
INTERVENTIONAL
TERMINATED
true
275
ACTUAL
Lupus Nephritis
Lupus Nephritis
DRUG; DRUG
secukinumab; Placebo
Novartis Pharmaceuticals
INDUSTRY
2020-07-07
2023-09-13
2024-10-10
RANDOMIZED
QUADRUPLE
TREATMENT
NCT04181762
secondary
6
Time to Achieve First Morning Void Urine Protein-to-Creatinine Ratio (UPCR) <= 0.5 mg/mg up to Week 52
biomarker_laboratory
time_to_event
null
unspecified
false
false
0.688
Baseline to Week 52
null
null
null
true
0
PHASE3
INTERVENTIONAL
TERMINATED
true
275
ACTUAL
Lupus Nephritis
Lupus Nephritis
DRUG; DRUG
secukinumab; Placebo
Novartis Pharmaceuticals
INDUSTRY
2020-07-07
2023-09-13
2024-10-10
RANDOMIZED
QUADRUPLE
TREATMENT
NCT04181762
secondary
7
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Mean Change From Baseline up to Week 52
patient_reported
change_from_baseline
null
unspecified
false
false
0.7
Baseline, Week 12, Week 24, Week 36, Week 52
null
null
null
true
0
PHASE3
INTERVENTIONAL
TERMINATED
true
275
ACTUAL
Lupus Nephritis
Lupus Nephritis
DRUG; DRUG
secukinumab; Placebo
Novartis Pharmaceuticals
INDUSTRY
2020-07-07
2023-09-13
2024-10-10
RANDOMIZED
QUADRUPLE
TREATMENT
NCT04181762
secondary
8
Short Form Health Survey (SF-36) Version 2 (Acute Form) Mean Change From Baseline in Physical Component Score (PCS) up to Week 52
patient_reported
change_from_baseline
quality_of_life
ambiguous
true
false
1
Baseline, Week 12, Week 24, Week 36, Week 52
null
null
null
true
0
PHASE3
INTERVENTIONAL
TERMINATED
true
275
ACTUAL
Lupus Nephritis
Lupus Nephritis
DRUG; DRUG
secukinumab; Placebo
Novartis Pharmaceuticals
INDUSTRY
2020-07-07
2023-09-13
2024-10-10
RANDOMIZED
QUADRUPLE
TREATMENT
NCT04181762
secondary
9
Lupus Quality of Life (LupusQoL) Physical Health Score Mean Change From Baseline up to Week 52
patient_reported
change_from_baseline
quality_of_life
ambiguous
true
false
1
Baseline, Week 12, Week 24, Week 36, Week 52
null
null
null
true
0
PHASE3
INTERVENTIONAL
TERMINATED
true
275
ACTUAL
Lupus Nephritis
Lupus Nephritis
DRUG; DRUG
secukinumab; Placebo
Novartis Pharmaceuticals
INDUSTRY
2020-07-07
2023-09-13
2024-10-10
RANDOMIZED
QUADRUPLE
TREATMENT
NCT04181762
secondary
10
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs)
safety
proportion
adverse_event_incidence
lower_is_better
true
false
0.98
From first dose of study treatment up to approximately 2 years
730.5
1
false
false
0.9
PHASE3
INTERVENTIONAL
TERMINATED
true
275
ACTUAL
Lupus Nephritis
Lupus Nephritis
DRUG; DRUG
secukinumab; Placebo
Novartis Pharmaceuticals
INDUSTRY
2020-07-07
2023-09-13
2024-10-10
RANDOMIZED
QUADRUPLE
TREATMENT
NCT04181762
secondary
11
Percentage of Participants With Complete Renal Response (CRR) at Week 104 Within Those Who Had Achieved CRR at Week 52 in the Secukinumab Group
unclassified
proportion
null
unspecified
false
false
0.34
Week 52 to Week 104
null
null
null
false
0
PHASE3
INTERVENTIONAL
TERMINATED
true
275
ACTUAL
Lupus Nephritis
Lupus Nephritis
DRUG; DRUG
secukinumab; Placebo
Novartis Pharmaceuticals
INDUSTRY
2020-07-07
2023-09-13
2024-10-10
RANDOMIZED
QUADRUPLE
TREATMENT
NCT04181762
secondary
12
Percentage of Participants With Improved or Maintained Response (PRR or CRR) at Week 104 in Those Who Had Achieved at Least PRR at Week 52 in the Secukinumab Group
unclassified
proportion
null
unspecified
false
false
0.34
Week 52 to Week 104
null
null
null
false
0
PHASE3
INTERVENTIONAL
TERMINATED
true
275
ACTUAL
Lupus Nephritis
Lupus Nephritis
DRUG; DRUG
secukinumab; Placebo
Novartis Pharmaceuticals
INDUSTRY
2020-07-07
2023-09-13
2024-10-10
RANDOMIZED
QUADRUPLE
TREATMENT
NCT06911242
primary
0
AUC0-t
pharmacokinetics
pk_parameter
pk_exposure
unspecified
true
false
1
From time zero (dose) to time of last quantifiable concentration. Period 1: 0 to 144 hours; Period 2: 0 to 168 hours.
7
2
true
false
0.65
PHASE1
INTERVENTIONAL
COMPLETED
true
16
ACTUAL
Healthy Volunteer
Healthy Volunteer; Pharmacokinetics After Oral Intake
DRUG
ARN-75039
Arisan Therapeutics, Inc.
INDUSTRY
2025-02-27
2025-04-21
2026-05-01
RANDOMIZED
NONE
BASIC_SCIENCE
NCT06911242
primary
1
AUC0-24
pharmacokinetics
pk_parameter
pk_exposure
unspecified
true
false
1
From time zero (dose) to 24 hours post-dose.
1
1
false
false
0.9
PHASE1
INTERVENTIONAL
COMPLETED
true
16
ACTUAL
Healthy Volunteer
Healthy Volunteer; Pharmacokinetics After Oral Intake
DRUG
ARN-75039
Arisan Therapeutics, Inc.
INDUSTRY
2025-02-27
2025-04-21
2026-05-01
RANDOMIZED
NONE
BASIC_SCIENCE
NCT06911242
primary
2
AUC0-∞
pharmacokinetics
pk_parameter
pk_exposure
unspecified
true
false
1
From time zero (dose) extrapolated to infinity. Time frame is from 0 to Tlast + extrapolation from C last to infinity time, where concentration is equal to 0.
null
null
null
false
0
PHASE1
INTERVENTIONAL
COMPLETED
true
16
ACTUAL
Healthy Volunteer
Healthy Volunteer; Pharmacokinetics After Oral Intake
DRUG
ARN-75039
Arisan Therapeutics, Inc.
INDUSTRY
2025-02-27
2025-04-21
2026-05-01
RANDOMIZED
NONE
BASIC_SCIENCE
NCT06911242
primary
3
Cmax
pharmacokinetics
pk_parameter
pk_exposure
unspecified
true
false
1
From time 0 (dose) through 168 hours post-dose.
7
1
false
false
0.9
PHASE1
INTERVENTIONAL
COMPLETED
true
16
ACTUAL
Healthy Volunteer
Healthy Volunteer; Pharmacokinetics After Oral Intake
DRUG
ARN-75039
Arisan Therapeutics, Inc.
INDUSTRY
2025-02-27
2025-04-21
2026-05-01
RANDOMIZED
NONE
BASIC_SCIENCE
NCT06911242
primary
4
Tmax
pharmacokinetics
time_to_event
pk_exposure
unspecified
true
false
1
From time 0 (dose) through 168 hours post-dose.
7
1
false
false
0.9
PHASE1
INTERVENTIONAL
COMPLETED
true
16
ACTUAL
Healthy Volunteer
Healthy Volunteer; Pharmacokinetics After Oral Intake
DRUG
ARN-75039
Arisan Therapeutics, Inc.
INDUSTRY
2025-02-27
2025-04-21
2026-05-01
RANDOMIZED
NONE
BASIC_SCIENCE
NCT06911242
primary
5
t1/2
pharmacokinetics
pk_parameter
pk_exposure
unspecified
true
false
1
From time 0 (dose) through 168 hours post-dose (terminal elimination phase).
7
1
false
false
0.9
PHASE1
INTERVENTIONAL
COMPLETED
true
16
ACTUAL
Healthy Volunteer
Healthy Volunteer; Pharmacokinetics After Oral Intake
DRUG
ARN-75039
Arisan Therapeutics, Inc.
INDUSTRY
2025-02-27
2025-04-21
2026-05-01
RANDOMIZED
NONE
BASIC_SCIENCE
NCT06911242
primary
6
CL/F
pharmacokinetics
pk_parameter
null
unspecified
false
false
0.748
From time 0 (dose) through 168 hours post-dose (derived from the concentration-time profile).
7
1
false
false
0.9
PHASE1
INTERVENTIONAL
COMPLETED
true
16
ACTUAL
Healthy Volunteer
Healthy Volunteer; Pharmacokinetics After Oral Intake
DRUG
ARN-75039
Arisan Therapeutics, Inc.
INDUSTRY
2025-02-27
2025-04-21
2026-05-01
RANDOMIZED
NONE
BASIC_SCIENCE
NCT06911242
primary
7
Vz/F
unclassified
pk_parameter
null
unspecified
false
false
0.368
From time 0 (dose) through 168 hours post-dose (derived from the concentration-time profile).
7
1
false
false
0.9
PHASE1
INTERVENTIONAL
COMPLETED
true
16
ACTUAL
Healthy Volunteer
Healthy Volunteer; Pharmacokinetics After Oral Intake
DRUG
ARN-75039
Arisan Therapeutics, Inc.
INDUSTRY
2025-02-27
2025-04-21
2026-05-01
RANDOMIZED
NONE
BASIC_SCIENCE
NCT06911242
secondary
0
Participants With β‰₯1 TEAE
safety
count
adverse_event_incidence
lower_is_better
true
false
0.96
From first dose through approximately 7 days after the last dose (includes washout); with Day 36 follow-up phone call to assess for any adverse events (AEs).
7
1
false
false
0.9
PHASE1
INTERVENTIONAL
COMPLETED
true
16
ACTUAL
Healthy Volunteer
Healthy Volunteer; Pharmacokinetics After Oral Intake
DRUG
ARN-75039
Arisan Therapeutics, Inc.
INDUSTRY
2025-02-27
2025-04-21
2026-05-01
RANDOMIZED
NONE
BASIC_SCIENCE
NCT06911242
secondary
1
Participants With β‰₯1 TESAE
safety
count
serious_adverse_events
lower_is_better
true
false
0.96
From first dose through approximately 7 days after the last dose (includes washout); with Day 36 follow-up phone call to assess for any adverse events (AEs).
7
1
false
false
0.9
PHASE1
INTERVENTIONAL
COMPLETED
true
16
ACTUAL
Healthy Volunteer
Healthy Volunteer; Pharmacokinetics After Oral Intake
DRUG
ARN-75039
Arisan Therapeutics, Inc.
INDUSTRY
2025-02-27
2025-04-21
2026-05-01
RANDOMIZED
NONE
BASIC_SCIENCE
NCT06911242
secondary
2
Participants With Study Drug-related TEAEs of Grade >1
safety
count
adverse_event_incidence
unspecified
true
false
0.96
From first dose through approximately 7 days after the last dose (includes washout); with Day 36 follow-up phone call to assess for any adverse events (AEs).
7
1
false
false
0.9
PHASE1
INTERVENTIONAL
COMPLETED
true
16
ACTUAL
Healthy Volunteer
Healthy Volunteer; Pharmacokinetics After Oral Intake
DRUG
ARN-75039
Arisan Therapeutics, Inc.
INDUSTRY
2025-02-27
2025-04-21
2026-05-01
RANDOMIZED
NONE
BASIC_SCIENCE
NCT04435808
primary
0
SARS-CoV-2 Infection
unclassified
count
null
unspecified
false
false
0.32
3 months
91.32
1
false
false
0.9
PHASE1; PHASE2
INTERVENTIONAL
TERMINATED
true
1
ACTUAL
COVID-19
COVID-19
DRUG
Hydroxychloroquine
University of New Mexico
OTHER
2020-04-14
2020-07-15
2020-11-16
NON_RANDOMIZED
NONE
PREVENTION
NCT05831189
primary
0
Number of Participants With RBX2660-related Treatment-emergent Adverse Events (TEAEs) After RBX2660 Treatment Delivered by Colonoscopy Through 8 Weeks, or Treatment Failure
safety
count
adverse_event_incidence
lower_is_better
true
false
0.96
8 weeks after RBX2660 treatment delivered by colonoscopy
56
1
false
false
0.9
PHASE3
INTERVENTIONAL
COMPLETED
true
41
ACTUAL
Clostridium Difficile Infection Recurrence
Clostridium Difficile Infection Recurrence
DRUG
RBX2660
Ferring Pharmaceuticals
INDUSTRY
2023-04-21
2025-01-17
2026-04-24
null
NONE
TREATMENT
NCT05831189
secondary
0
Number of Participants With Recurrence of Clostridioides Difficile Infection (CDI) Within 8 Weeks After RBX2660 Treatment Delivered by Colonoscopy.
efficacy
count
null
lower_is_better
false
false
0.62
Within 8 weeks after RBX2660 treatment delivered by colonoscopy
56
1
false
false
0.9
PHASE3
INTERVENTIONAL
COMPLETED
true
41
ACTUAL
Clostridium Difficile Infection Recurrence
Clostridium Difficile Infection Recurrence
DRUG
RBX2660
Ferring Pharmaceuticals
INDUSTRY
2023-04-21
2025-01-17
2026-04-24
null
NONE
TREATMENT
NCT05831189
secondary
1
Time to CDI Recurrence From Baseline Through 8 Weeks After RBX2660 Treatment Delivered by Colonoscopy
efficacy
time_to_event
null
lower_is_better
false
false
0.668
8 weeks after RBX2660 treatment delivered by colonoscopy
56
1
false
false
0.9
PHASE3
INTERVENTIONAL
COMPLETED
true
41
ACTUAL
Clostridium Difficile Infection Recurrence
Clostridium Difficile Infection Recurrence
DRUG
RBX2660
Ferring Pharmaceuticals
INDUSTRY
2023-04-21
2025-01-17
2026-04-24
null
NONE
TREATMENT
NCT05831189
secondary
2
Physician-experience, as Determined by Questionnaire, Documenting Subjective Experience of Investigators on Usability of RBX2660 in Clinical Practice When Delivered by Colonoscopy
patient_reported
score_scale
null
unspecified
false
false
0.66
At Day 1 (baseline visit)
null
null
null
true
0
PHASE3
INTERVENTIONAL
COMPLETED
true
41
ACTUAL
Clostridium Difficile Infection Recurrence
Clostridium Difficile Infection Recurrence
DRUG
RBX2660
Ferring Pharmaceuticals
INDUSTRY
2023-04-21
2025-01-17
2026-04-24
null
NONE
TREATMENT
NCT05831189
secondary
3
Physician Perception of Patient Benefit, as Determined by Number of Participants With Clinician Global Impression of Improvement (CGI-I) at 8 Weeks, or at Treatment Failure, After RBX2660 Treatment Delivered by Colonoscopy
efficacy
count
null
ambiguous
false
false
0.62
8 weeks after RBX2660 treatment delivered by colonoscopy
56
1
false
false
0.9
PHASE3
INTERVENTIONAL
COMPLETED
true
41
ACTUAL
Clostridium Difficile Infection Recurrence
Clostridium Difficile Infection Recurrence
DRUG
RBX2660
Ferring Pharmaceuticals
INDUSTRY
2023-04-21
2025-01-17
2026-04-24
null
NONE
TREATMENT
NCT05831189
secondary
4
Patient-experience Interview at 8 Weeks, or at Treatment Failure, After RBX2660 Treatment Delivered by Colonoscopy
efficacy
unclassified
null
lower_is_better
false
false
0.3
8 weeks after RBX2660 treatment delivered by colonoscopy
56
1
false
false
0.9
PHASE3
INTERVENTIONAL
COMPLETED
true
41
ACTUAL
Clostridium Difficile Infection Recurrence
Clostridium Difficile Infection Recurrence
DRUG
RBX2660
Ferring Pharmaceuticals
INDUSTRY
2023-04-21
2025-01-17
2026-04-24
null
NONE
TREATMENT
NCT05831189
secondary
5
Number of Participants With Treatment-emergent Adverse Events up to 8 Weeks or Treatment Failure After RBX2660 Treatment
safety
count
adverse_event_incidence
lower_is_better
true
false
0.96
Up to 8 weeks after RBX2660 treatment delivered by colonoscopy
56
1
false
false
0.9
PHASE3
INTERVENTIONAL
COMPLETED
true
41
ACTUAL
Clostridium Difficile Infection Recurrence
Clostridium Difficile Infection Recurrence
DRUG
RBX2660
Ferring Pharmaceuticals
INDUSTRY
2023-04-21
2025-01-17
2026-04-24
null
NONE
TREATMENT
NCT05831189
secondary
6
Number of Participants With Serious Adverse Events (SAEs)
safety
count
serious_adverse_events
lower_is_better
true
false
0.96
Up to 8 weeks after RBX2660 treatment delivered by colonoscopy
56
1
false
false
0.9
PHASE3
INTERVENTIONAL
COMPLETED
true
41
ACTUAL
Clostridium Difficile Infection Recurrence
Clostridium Difficile Infection Recurrence
DRUG
RBX2660
Ferring Pharmaceuticals
INDUSTRY
2023-04-21
2025-01-17
2026-04-24
null
NONE
TREATMENT
NCT05831189
secondary
7
Number of Participants With Any Adverse Events of Special Interest (AESIs)
safety
count
adverse_event_incidence
lower_is_better
true
false
0.96
Up to 8 weeks after RBX2660 treatment delivered by colonoscopy
56
1
false
false
0.9
PHASE3
INTERVENTIONAL
COMPLETED
true
41
ACTUAL
Clostridium Difficile Infection Recurrence
Clostridium Difficile Infection Recurrence
DRUG
RBX2660
Ferring Pharmaceuticals
INDUSTRY
2023-04-21
2025-01-17
2026-04-24
null
NONE
TREATMENT
NCT05831189
secondary
8
Number of Participants With Adverse Events Leading to Death or Intensive Care Unit (ICU) Admission
safety
count
adverse_event_incidence
lower_is_better
true
false
0.96
Up to 8 weeks after RBX2660 treatment delivered by colonoscopy
56
1
false
false
0.9
PHASE3
INTERVENTIONAL
COMPLETED
true
41
ACTUAL
Clostridium Difficile Infection Recurrence
Clostridium Difficile Infection Recurrence
DRUG
RBX2660
Ferring Pharmaceuticals
INDUSTRY
2023-04-21
2025-01-17
2026-04-24
null
NONE
TREATMENT
NCT05135650
primary
0
Half-life of Sotrovimab (VIR-7831) Post-transplant
pharmacokinetics
pk_parameter
pk_exposure
unspecified
true
false
1
Up to 24 weeks
168
1
false
false
0.9
PHASE1
INTERVENTIONAL
TERMINATED
true
20
ACTUAL
COVID-19 Infection
COVID-19 Infection; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
OTHER; BIOLOGICAL; PROCEDURE
Questionnaire Administration; Sotrovimab; Biospecimen Collection
Fred Hutchinson Cancer Center
OTHER
2022-01-25
2023-01-10
2025-02-13
null
NONE
PREVENTION
NCT05135650
primary
1
Neutralizing Antibody Titers
immunogenicity
change_from_baseline
null
unspecified
false
false
0.72
Up to 24 weeks
168
1
false
false
0.9
PHASE1
INTERVENTIONAL
TERMINATED
true
20
ACTUAL
COVID-19 Infection
COVID-19 Infection; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
OTHER; BIOLOGICAL; PROCEDURE
Questionnaire Administration; Sotrovimab; Biospecimen Collection
Fred Hutchinson Cancer Center
OTHER
2022-01-25
2023-01-10
2025-02-13
null
NONE
PREVENTION
NCT05135650
secondary
0
Half-life of VIR-7831 in Matched vs Mismatched Donors
pharmacokinetics
pk_parameter
pk_exposure
unspecified
true
false
1
Up to 24 weeks
168
1
false
false
0.9
PHASE1
INTERVENTIONAL
TERMINATED
true
20
ACTUAL
COVID-19 Infection
COVID-19 Infection; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
OTHER; BIOLOGICAL; PROCEDURE
Questionnaire Administration; Sotrovimab; Biospecimen Collection
Fred Hutchinson Cancer Center
OTHER
2022-01-25
2023-01-10
2025-02-13
null
NONE
PREVENTION
NCT05135650
secondary
1
Half-life of VIR-7831 in Autologous vs Allogeneic HCT
pharmacokinetics
pk_parameter
pk_exposure
unspecified
true
false
1
Up to 24 weeks
168
1
false
false
0.9
PHASE1
INTERVENTIONAL
TERMINATED
true
20
ACTUAL
COVID-19 Infection
COVID-19 Infection; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
OTHER; BIOLOGICAL; PROCEDURE
Questionnaire Administration; Sotrovimab; Biospecimen Collection
Fred Hutchinson Cancer Center
OTHER
2022-01-25
2023-01-10
2025-02-13
null
NONE
PREVENTION
NCT05135650
secondary
2
VIR-7831 Exposure in Patients With Diarrhea vs no Diarrhea
pharmacokinetics
pk_parameter
pk_exposure
unspecified
true
false
1
Up to 24 weeks
168
1
false
false
0.9
PHASE1
INTERVENTIONAL
TERMINATED
true
20
ACTUAL
COVID-19 Infection
COVID-19 Infection; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
OTHER; BIOLOGICAL; PROCEDURE
Questionnaire Administration; Sotrovimab; Biospecimen Collection
Fred Hutchinson Cancer Center
OTHER
2022-01-25
2023-01-10
2025-02-13
null
NONE
PREVENTION
End of preview. Expand in Data Studio

Clinical Trial Outcomes (2020+) with Normalized Endpoints

124,790 normalized endpoints across 14,170 clinical studies that started on or after 2020-01-01 and have posted results on ClinicalTrials.gov.

Snapshot: 2026-09-08. Source: ClinicalTrials.gov API v2 (U.S. National Library of Medicine).

Built with ctgov β€” the same normalizer, released as an

MIT-licensed package with zero dependencies. So this snapshot is not a dead artifact: you can

re-run it against the live registry, or normalize endpoints it does not cover.

The problem this solves

ClinicalTrials.gov stores trial endpoints as free prose. Straight from the API, you get this:

raw endpoint text raw timeframe
Primary Safety: Freedom From Index Procedure Related Major Complications 30 days
Serum Markers (HbA1c) to Follow the Evolution of Liver Damage 6 months
Cmax of midazolam 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose
Anxiety Rating Baseline

You cannot group, filter, or compare across trials with that. Every cross-trial analysis starts by rebuilding the same normalization layer from scratch.

This dataset ships that layer:

endpoint_domain endpoint_measure_type endpoint_canonical horizon_days direction
safety proportion β€” 30.0 higher_is_better
biomarker_laboratory change_from_baseline hba1c_change 182.64 lower_is_better
pharmacokinetics pk_parameter pk_exposure 0.5 unspecified
patient_reported score_scale anxiety_score 0.0 lower_is_better

The raw text is preserved on every row, so any normalization can be audited rather than trusted.

Quick start

from datasets import load_dataset

ds = load_dataset("GooseWithStories/clinical-trial-outcomes-2020plus", "endpoints", split="train")

# High-precision Phase 3 survival endpoints in industry trials
rows = ds.filter(lambda r:
    r["endpoint_canonical"] == "overall_survival"
    and "PHASE3" in (r["phase"] or "")
    and r["sponsor_class"] == "INDUSTRY"
    and r["normalization_confidence"] >= 0.7
)

What's inside

config rows description
endpoints (default) 124,790 One row per (study, endpoint), study attributes denormalized on.
studies 14,170 One row per study, with endpoint counts.

Normalized fields

  • endpoint_domain β€” safety, efficacy, patient_reported, pharmacokinetics, biomarker_laboratory, clinical_assessment, behavioral_functional, healthcare_utilization, immunogenicity, feasibility_implementation, diagnostic_accuracy, unclassified
  • endpoint_measure_type β€” change_from_baseline, proportion, count, score_scale, time_to_event, pk_parameter, concentration, continuous_value, diagnostic_accuracy, unclassified
  • endpoint_canonical β€” one of 38 standard concepts where they apply: overall_survival, progression_free_survival, invasive_disease_free_survival, objective_response_rate, pathologic_complete_response, dose_limiting_toxicity, adverse_event_incidence, serious_adverse_events, hba1c_change, cgm_time_in_range, clinical_status_ordinal_scale, quality_of_life, seroconversion, pk_exposure, and more
  • endpoint_direction β€” higher_is_better / lower_is_better / ambiguous / unspecified
  • horizon_days β€” free-text timeframe parsed to a number (hours Γ· 24, weeks Γ— 7, months Γ— 30.44, years Γ— 365.25, cycles Γ— 21)
  • normalization_confidence β€” 0–1 per row. Recommended filter: >= 0.7

Plus full study context on every row: phase, study_type, overall_status, enrollment_count, condition_primary, conditions_all, intervention_types, intervention_names, lead_sponsor, sponsor_class, allocation, masking, primary_purpose, and dates.

Coverage β€” stated honestly

Unclassified rates are published as prominently as success rates. An accurate coverage number is more useful than a confident label on every row.

metric value
Endpoints with an assigned clinical domain 71.9%
Endpoints with an assigned measure type 90.2%
Endpoints with a parsed numeric time horizon 61.3%
Endpoints mapped to a canonical concept 35.0%
domain n domain n
unclassified 35,026 clinical_assessment 9,199
patient_reported 16,146 biomarker_laboratory 8,973
safety 14,764 healthcare_utilization 5,435
efficacy 13,715 behavioral_functional 4,985
pharmacokinetics 10,439 immunogenicity 3,688
feasibility_implementation 2,084
diagnostic_accuracy 336

On the 28.1% unclassified: a genuine long tail of disease-specific measures ("Swollen Joint Count", "Bowel Filling Properties: Distension/Distal Ileum"). Rather than force these into an ill-fitting bucket, they are labelled unclassified with raw text retained. endpoint_domain_inferred = true marks rows whose domain was set by a recognised canonical concept. The concept outranks loose keywords, so this is the stronger signal β€” do not filter these rows out. endpoint_measure_inferred = true marks rows whose measure type was taken from the concept because the text named none.

Method

  1. Fetch β€” ClinicalTrials.gov API v2, filtered to AREA[StartDate]RANGE[2020-01-01,MAX] and AREA[HasResults]true, rate-limited well under NLM's 20 req/s ceiling.
  2. Normalize β€” a deterministic, ordered rule cascade (specific β†’ general, first match wins) assigns domain, measure type, canonical concept and direction; a unit-aware parser converts free-text timeframes to horizon_days.
  3. Emit β€” CSV + JSONL with a machine-readable coverage report.

No model inference in the pipeline. The normalizer is fully deterministic, so it is reproducible, auditable, and free to re-run against the live registry.

The taxonomy was built empirically: an initial version left 50.1% of endpoints without a domain, so categories were derived by inspecting actual failures rather than assumed up front. That surfaced whole missing classes (laboratory/biomarker, healthcare utilization, feasibility/implementation) and two outright bugs β€” death\b never matched "Deaths", and number of (participants) missed "Number of Episodes". First release: 32.6% unclassified; 28.1% after the ctgov 0.1.1 fixes (see Corrections).

Rebuild or extend it yourself

The normalizer is on PyPI and its source is in src/ in this repo, so nothing here is a black box.


pip install ctgov

from ctgov import endpoints



# Same columns as this dataset, for any query - including trials with no posted results,

# which this snapshot excludes.

rows = endpoints("AREA[Condition]melanoma", max_studies=500)

ctgov also pages past the API's 1,000-study response cap, which is how this dataset's 14,170

studies were pulled. Source and changelog: github.com/GooseWithTheStories/ctgov.

Corrections

v1.2 (2026-09-10) β€” normalizer ctgov 0.1.1.

Every change was checked row by row against v1.1, rebuilt from the committed pipeline (it reproduces v1.1's published coverage exactly). 9,309 rows (7.5%) changed domain and 12,082 (9.7%) changed concept. Coverage: domain 67.4% β†’ 71.9%, measure type 86.6% β†’ 90.2%, concept 27.6% β†’ 35.0%.

  • A definition no longer overrides the endpoint's name. Concepts are read from the endpoint name first and from the description only as a fallback. 275 rows v1.1 filed as hospitalization are adverse-event endpoints whose definitions mention hospitalization; 421 EQ-5D and EORTC QLQ-C30 rows move from depression / cognitive / pain to quality_of_life; serious-AE endpoints are serious_adverse_events unless they also count any AE.
  • Dose-limiting toxicity, the standard Phase 1 primary endpoint, is now recognised (dose_limiting_toxicity, domain safety): 541 rows, 28 of which had carried hospitalization because DLT definitions say "requiring hospitalization".
  • Ordinal clinical-status scales (WHO / NIAID, mostly COVID-19 trials): 662 rows are now clinical_status_ordinal_scale. Their category lists ("Hospitalized, on oxygen ... Not hospitalized") had made them look like hospitalization endpoints.
  • Word stems that could never match (toxicity, feasibility, plurals) now do: unclassified domain 40,659 β†’ 35,026; feasibility 1,056 β†’ 2,084; pharmacokinetics 8,891 β†’ 10,439.
  • Precision: diagnostic_accuracy needs diagnostic context, so insulin sensitivity, contrast sensitivity and high-sensitivity CRP no longer count; "hospitalized" counts only when it names the outcome ("participants who were hospitalized"), not the population ("in hospitalized adults").
  • Terse rows no longer fall below the confidence bar. A bare "HbA1c" or "Overall Response Rate" scored 0.64 because the text named no measure; the measure type is now taken from the concept and flagged in the new endpoint_measure_inferred column (3,118 rows). Recovered above 0.7: objective response rate 192, complete response 113, pCR 33, HbA1c 100, blood pressure 350, PFS 64.
  • New concepts: duration_of_response 828, clinical_status_ordinal_scale 662, cgm_glycemic_metric 592, dose_limiting_toxicity 541, disease_control_rate 341, fasting_glucose 195, cgm_time_in_range 143, clinical_benefit_rate 114, pathologic_complete_response 90 (distinct from clinical complete_response; case-sensitive, so COVID-19 "PCR" does not match), time_to_next_treatment 72, urine_albumin_creatinine_ratio 71, recurrence_free_survival 54, ki67_response 44, and the adjuvant breast-cancer family (distant RFS 18, locoregional recurrence 5, iDFS 4, IBCFS 1).
  • endpoint_domain_inferred marks the stronger signal; earlier documentation said the opposite and advised filtering those rows out. Do not.

v1.1 (2026-09-09) β€” survival endpoint reclassification. An earlier build of this dataset misclassified survival endpoints. Because Overall Survival is defined as "time from randomization until death", the word "death" caused the classifier to assign safety rather than efficacy. Affected:

  • overall_survival: 827 of 1,116 rows (74%) were safety; now all 1,116 are efficacy
  • progression_free_survival: 1,046 of 1,418 rows (74%) were safety; now all 1,418 are efficacy

Fixed by making a recognised canonical concept outrank a loose keyword match. Two further fixes landed in the same build: "Glycosylated Haemoglobin" now maps to hba1c_change (only the glycated spelling was matched before), and shared-unit sampling schedules such as "0, 0.5, 1 ... 12 hours post-dose" are now counted as ten timepoints rather than one β€” 18,820 endpoints (24.6% of parsed schedules) are now correctly flagged is_longitudinal.

In total roughly 5,200 rows (4.2%) changed domain. If you pulled an earlier copy, re-download.

Limitations

  • Only studies with posted results are included. This biases toward completed, larger and industry-sponsored trials; it is not a representative sample of all registered trials.
  • horizon_days is the maximum timepoint mentioned, not a schedule. Dense PK sampling strings get timepoint_count > 1 and timeframe_confidence = 0.65 to signal this.
  • Direction is inferred from wording; ambiguous/unspecified where wording doesn't settle it.
  • Endpoint results (measured values from the registry's results section) are not in this release β€” this covers endpoint definitions and study metadata.

Licence and attribution

Source data is in the public domain (U.S. Government work). This derived dataset adds only a normalization layer and is released CC0-1.0.

This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.

The NLM name and logo are not used to endorse this dataset.

Citation

@misc{clinical_trial_outcomes_2020plus,
  title  = {Clinical Trial Outcomes (2020+) with Normalized Endpoints},
  year   = {2026},
  note   = {Derived from ClinicalTrials.gov API v2, U.S. National Library of Medicine.
            Snapshot 2026-09-08.},
  url    = {https://huggingface.co/datasets/GooseWithStories/clinical-trial-outcomes-2020plus}
}
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