Trials that use: Interim analysis / alpha spending
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3,081 results
- A Patient-facing Tool to Reduce Opioid-Psychotropic Polypharmacy in People Living With Dementia (PLWD): Complete Statistical AnalysisIndependent statistical analysis of A Patient-facing Tool to Reduce Opioid-Psychotropic Polypharmacy in People Living With Dementia (PLWD): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…
- A Pharmacodynamic Study to Evaluate Neutrophil Distribution Kinetics and Function Following Single-Dose RoActemra/Actemra (Tocilizumab) in Healthy Volunteers: Complete Statistical AnalysisIndependent statistical analysis of A Pharmacodynamic Study to Evaluate Neutrophil Distribution Kinetics and Function Following Single-Dose RoActemra/Actemra (Tocilizumab) in Healthy Volunteers: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration,…
- A Pharmacokinetic and Pharmacodynamic Evaluation of Cytisine in Healthy Smokers: Complete Statistical AnalysisIndependent statistical analysis of A Pharmacokinetic and Pharmacodynamic Evaluation of Cytisine in Healthy Smokers: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT03303911).
- A Pharmacokinetic Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-007): Complete Statistical AnalysisIndependent statistical analysis of A Pharmacokinetic Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-007): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov…
- A Phase 1 Study of Continuous Intravenous L-citrulline During Sickle Cell Pain Crisis or Acute Chest Syndrome: Complete Statistical AnalysisIndependent statistical analysis of A Phase 1 Study of Continuous Intravenous L-citrulline During Sickle Cell Pain Crisis or Acute Chest Syndrome: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration,…
- A Phase 1 Study of Mixed Bacteria Vaccine (MBV) in Patients With Tumors Expressing NY-ESO-1 Antigen: Complete Statistical AnalysisIndependent statistical analysis of A Phase 1 Study of Mixed Bacteria Vaccine (MBV) in Patients With Tumors Expressing NY-ESO-1 Antigen: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…
- A Phase 1/2 Trial of Multiple Oral Doses of OPC-167832 for Uncomplicated Pulmonary Tuberculosis: Complete Statistical AnalysisIndependent statistical analysis of A Phase 1/2 Trial of Multiple Oral Doses of OPC-167832 for Uncomplicated Pulmonary Tuberculosis: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…
- A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of Alomfilimab (KY1044) as Single Agent and in Combination With Anti-PD-L1 (Atezolizumab) in Adult Patients With Selected Advanced Malignancies: Complete Statistical AnalysisIndependent statistical analysis of A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of Alomfilimab (KY1044) as Single Agent and in Combination With Anti-PD-L1 (Atezolizumab) in Adult Patients With Selected…
- A Phase 1/2, Randomized, Placebo-controlled, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Adults 18 To 49 Years Of Age: Complete Statistical AnalysisIndependent statistical analysis of A Phase 1/2, Randomized, Placebo-controlled, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Adults 18 To 49 Years…
- A Phase 1b Open-Label Study Investigating the Safety and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin’s Lymphoma: Complete Statistical AnalysisIndependent statistical analysis of A Phase 1b Open-Label Study Investigating the Safety and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma: primary endpoint results, effect estimate…
- A Phase 2 Dose Escalating Study to Evaluate the Safety and Efficacy of CB-03-01 Cream in Subjects With Facial Acne Vulgaris: Complete Statistical AnalysisIndependent statistical analysis of A Phase 2 Dose Escalating Study to Evaluate the Safety and Efficacy of CB-03-01 Cream in Subjects With Facial Acne Vulgaris: primary endpoint results, effect estimate with confidence…
- A Phase 2 Multi-Center Study To Evaluate The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist In Adults With Type 2 Diabetes And Overt Nephropathy: Complete Statistical AnalysisIndependent statistical analysis of A Phase 2 Multi-Center Study To Evaluate The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist In Adults With Type 2 Diabetes And Overt Nephropathy: primary endpoint…
- A Phase 2 Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202): Complete Statistical AnalysisIndependent statistical analysis of A Phase 2 Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202): primary endpoint results, effect estimate with confidence interval,…
- A Phase 2 Study of Sitravatinib in Combination With PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma: Complete Statistical AnalysisIndependent statistical analysis of A Phase 2 Study of Sitravatinib in Combination With PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma: primary endpoint results, effect estimate with confidence…
- A Phase 2 Study to Evaluate AL001 in C9orf72-Associated ALS: Complete Statistical AnalysisIndependent statistical analysis of A Phase 2 Study to Evaluate AL001 in C9orf72-Associated ALS: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT05053035).
- A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis: Complete Statistical AnalysisIndependent statistical analysis of A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis: primary endpoint results, effect estimate with confidence…
- A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in Healthy Infants: Complete Statistical AnalysisIndependent statistical analysis of A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in Healthy Infants: primary endpoint results, effect estimate with confidence interval, sample-size planning…
- A Phase 2 Study With Enzastaurin Plus Chemotherapy or Placebo Plus Chemotherapy for Prostate Cancer Patients: Complete Statistical AnalysisIndependent statistical analysis of A Phase 2 Study With Enzastaurin Plus Chemotherapy or Placebo Plus Chemotherapy for Prostate Cancer Patients: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…
- A Phase 2a Study Evaluating BIVV020 in Adults With Persistent/Chronic Immune Thrombocytopenia (ITP): Complete Statistical AnalysisIndependent statistical analysis of A Phase 2a Study Evaluating BIVV020 in Adults With Persistent/Chronic Immune Thrombocytopenia (ITP): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…
- A Phase 2A Study to Evaluate the Safety and Effect on Exercise Challenge Testing of MEDI-528 in Adults With Asthma: Complete Statistical AnalysisIndependent statistical analysis of A Phase 2A Study to Evaluate the Safety and Effect on Exercise Challenge Testing of MEDI-528 in Adults With Asthma: primary endpoint results, effect estimate with confidence interval,…
- A Phase 2a, Randomized, Placebo Controlled, Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Primary Sjögren’s Syndrome: Complete Statistical AnalysisIndependent statistical analysis of A Phase 2a, Randomized, Placebo Controlled, Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Primary Sjögren's Syndrome: primary endpoint results, effect estimate with confidence interval,…
- A Phase 2b Diabetic Kidney Disease Study: Complete Statistical AnalysisIndependent statistical analysis of A Phase 2b Diabetic Kidney Disease Study: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT04170543).
- A Phase 2B Multicenter, Randomized, Comparative Trial Of UK-453,061 Versus Etravirine In Combination With Darunavir/Ritonavir And A Nucleos(t)Ide Reverse Transcriptase Inhibitor For The Treatment Of Antiretroviral Experienced HIV-1 Infected Subjects With Evidence Of NNRTI Resistant HIV-1: Complete Statistical AnalysisIndependent statistical analysis of A Phase 2B Multicenter, Randomized, Comparative Trial Of UK-453,061 Versus Etravirine In Combination With Darunavir/Ritonavir And A Nucleos(t)Ide Reverse Transcriptase Inhibitor For The Treatment Of Antiretroviral Experienced HIV-1…
- A Phase 2b Study of CSL112 in Subjects With Acute Myocardial Infarction.: Complete Statistical AnalysisIndependent statistical analysis of A Phase 2b Study of CSL112 in Subjects With Acute Myocardial Infarction.: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov…
- A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants With Refractory Generalized Myasthenia Gravis (gMG): Complete Statistical AnalysisIndependent statistical analysis of A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants With Refractory Generalized Myasthenia Gravis (gMG): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…
- A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma.: Complete Statistical AnalysisIndependent statistical analysis of A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma.: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety,…
- A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1): Complete Statistical AnalysisIndependent statistical analysis of A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1): primary endpoint results, effect estimate…
- A Phase 3 Study of Amifampridine Phosphate in Patients With Lambert Eaton Myasthenic Syndrome (LEMS): Complete Statistical AnalysisIndependent statistical analysis of A Phase 3 Study of Amifampridine Phosphate in Patients With Lambert Eaton Myasthenic Syndrome (LEMS): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety,…
- A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial): Complete Statistical AnalysisIndependent statistical analysis of A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial): primary endpoint results, effect…
- A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis: Complete Statistical AnalysisIndependent statistical analysis of A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results…
- A Phase 3 Study of TVP-1012 (1 mg) in Early Parkinson’s Disease Patients: Complete Statistical AnalysisIndependent statistical analysis of A Phase 3 Study of TVP-1012 (1 mg) in Early Parkinson's Disease Patients: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…
- A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis: Complete Statistical AnalysisIndependent statistical analysis of A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…
- A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants: Complete Statistical AnalysisIndependent statistical analysis of A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants:…
- A Phase 3 Trial of the VLP-Based Chikungunya Vaccine PXVX0317 (CHIKV VLP Vaccine): Complete Statistical AnalysisIndependent statistical analysis of A Phase 3 Trial of the VLP-Based Chikungunya Vaccine PXVX0317 (CHIKV VLP Vaccine): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…
- A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Comparing CP- 690,550 And Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis: Complete Statistical AnalysisIndependent statistical analysis of A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Comparing CP- 690,550 And Etanercept In Subjects With Moderate To Severe Chronic…
- A Phase 3, Multicenter, Randomized, Double-blind,Active-controlled, Parallel-group Trial With an Open-labelExtension Phase to Evaluate the Efficacy and Safety of OralE5501 Versus Eltrombopag, in Adults With Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura): Complete Statistical AnalysisIndependent statistical analysis of A Phase 3, Multicenter, Randomized, Double-blind,Active-controlled, Parallel-group Trial With an Open-labelExtension Phase to Evaluate the Efficacy and Safety of OralE5501 Versus Eltrombopag, in Adults With Chronic ImmuneThrombocytopenia (Idiopathic…
- A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702): Complete Statistical AnalysisIndependent statistical analysis of A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702): primary endpoint results, effect estimate with confidence interval, sample-size planning…
- A Phase 3b Study of Erythropoietin Drugs Using a Specified Dosing Algorithm in Patients With Chronic Kidney Disease on Hemodialysis: Complete Statistical AnalysisIndependent statistical analysis of A Phase 3b Study of Erythropoietin Drugs Using a Specified Dosing Algorithm in Patients With Chronic Kidney Disease on Hemodialysis: primary endpoint results, effect estimate with confidence interval,…
- A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults: Complete Statistical AnalysisIndependent statistical analysis of A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults: primary endpoint results, effect estimate with confidence interval,…
- A Phase 4 Study to Assess the Effects of Aripiprazole Versus Other Atypical Antipsychotics in the Treatment of Schizophrenic Patients With Metabolic Syndrome: Complete Statistical AnalysisIndependent statistical analysis of A Phase 4 Study to Assess the Effects of Aripiprazole Versus Other Atypical Antipsychotics in the Treatment of Schizophrenic Patients With Metabolic Syndrome: primary endpoint results, effect estimate…
- A Phase 4, Randomized, Double-blind, Parallel-group, Comparative Study and a Phase 4, Open-label, Long-term Study of SYR-472 (100 mg) in Combination With Insulin in Patients With Type 2 Diabetes: Complete Statistical AnalysisIndependent statistical analysis of A Phase 4, Randomized, Double-blind, Parallel-group, Comparative Study and a Phase 4, Open-label, Long-term Study of SYR-472 (100 mg) in Combination With Insulin in Patients With Type 2…
- A Phase I Study of MK-2206 in Combination With Standard Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors (MK-2206-003): Complete Statistical AnalysisIndependent statistical analysis of A Phase I Study of MK-2206 in Combination With Standard Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors (MK-2206-003): primary endpoint results, effect estimate with confidence…
- A Phase I/II Open-Label Study of Ipilimumab and GM-CSF Administered to Unresectable Stage IIIC and Stage IV Melanoma Patients: Complete Statistical AnalysisIndependent statistical analysis of A Phase I/II Open-Label Study of Ipilimumab and GM-CSF Administered to Unresectable Stage IIIC and Stage IV Melanoma Patients: primary endpoint results, effect estimate with confidence interval, sample-size…
- A Phase I/II Trial of Crolibulin (EPC2407) Plus Cisplatin in Adults With Solid Tumors With a Focus on Anaplastic Thyroid Cancer (ATC): Complete Statistical AnalysisIndependent statistical analysis of A Phase I/II Trial of Crolibulin (EPC2407) Plus Cisplatin in Adults With Solid Tumors With a Focus on Anaplastic Thyroid Cancer (ATC): primary endpoint results, effect estimate with…
- A Phase I/II Trial of VR-CHOP in Lymphoma Patients: Complete Statistical AnalysisIndependent statistical analysis of A Phase I/II Trial of VR-CHOP in Lymphoma Patients: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT00634179).
- A Phase I/II, Open-label Study of Ofatumumab Added to Chlorambucil in Previously Untreated Japanese Patients With Chronic Lymphocytic Leukemia: Complete Statistical AnalysisIndependent statistical analysis of A Phase I/II, Open-label Study of Ofatumumab Added to Chlorambucil in Previously Untreated Japanese Patients With Chronic Lymphocytic Leukemia: primary endpoint results, effect estimate with confidence interval, sample-size…
- A Phase Ib, Open-label, Multicenter Study of the Safety and PK of the Combination of rhuMAb2c4 (Omnitarg), a Recombinant Humanized Antibody to HER2, and Capecitabine (Xeloda) in Patients With Advanced Solid Tumors: Complete Statistical AnalysisIndependent statistical analysis of A Phase Ib, Open-label, Multicenter Study of the Safety and PK of the Combination of rhuMAb2c4 (Omnitarg), a Recombinant Humanized Antibody to HER2, and Capecitabine (Xeloda) in Patients…
- A Phase II Neoadjuvant Study of Apalutamide, Abiraterone Acetate, Prednisone, Degarelix and Indomethacin in Men With Localized Prostate Cancer Pre-prostatectomy: Complete Statistical AnalysisIndependent statistical analysis of A Phase II Neoadjuvant Study of Apalutamide, Abiraterone Acetate, Prednisone, Degarelix and Indomethacin in Men With Localized Prostate Cancer Pre-prostatectomy: primary endpoint results, effect estimate with confidence interval,…
- A Phase II Study of 131I- Metaiodobenzylguanidine (MIBG) for Treatment of Metastatic or Unresectable Pheochromocytoma and Related Tumors: Complete Statistical AnalysisIndependent statistical analysis of A Phase II Study of 131I- Metaiodobenzylguanidine (MIBG) for Treatment of Metastatic or Unresectable Pheochromocytoma and Related Tumors: primary endpoint results, effect estimate with confidence interval, sample-size planning…
- A Phase II Study of Akt Inhibitor MK2206 in the Treatment of Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Peritoneal Cancer: Complete Statistical AnalysisIndependent statistical analysis of A Phase II Study of Akt Inhibitor MK2206 in the Treatment of Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Peritoneal Cancer: primary endpoint results, effect estimate with confidence interval,…