Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000638-75 | EudraCT Number |
Not provided
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Not provided
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This study determines the Annualized Relapse Rate (ARR) in participants with RMS after 96 weeks (approximately 2 years) treatment with intravenous (IV) infusion of ublituximab/oral placebo compared to 14 mg oral teriflunomide/IV placebo.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ublituximab + Oral Placebo | Experimental | Participants were administered ublituximab 150 milligrams (mg), intravenous (IV) infusion over 4 hours (h) on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo once daily (QD) from Day 1 up to the last day of Week 95. |
|
| Teriflunomide + IV Placebo | Active Comparator | Participants were administered teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ublituximab | Biological | Administered as an IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Relapse Rate (ARR) | ARR is defined as the number of Independent Relapse Adjudication Panel (IRAP)-confirmed relapses per participant year. The estimate of ARR for a treatment group is the total number of relapses for participants in the respective treatment group divided by the sum of treatment duration for participants in that specific treatment group. | Up to 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Gadolinium (Gd)-Enhancing T1-Lesions Per Magnetic Resonance Imaging (MRI) Scan Per Participant | The total number of Gd-enhancing T1-lesions were calculated as the sum of the individual number of lesions at Weeks 12, 24, 48, and 96, divided by the total number of MRI scans of the brain. | Weeks 12, 24, 48, and 96 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TG Therapeutics RMS Investigational Trial Site | Carlsbad | California | 92001 | United States | ||
| TG Therapeutics RMS Investigational Trial Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42292352 | Derived | Robertson D, Alvarez E, Steinman L, Hartung HP, Qian P, Selmaj K, Wray S, Wynn D, Fox EJ, Mok K, Miskin HP, Xu Y, Garner CA, Cree BAC. Disease outcomes with ublituximab in treatment-naive participants: subpopulation analyses of the phase 3 ULTIMATE I and II studies in participants with relapsing multiple sclerosis. Front Immunol. 2026 May 29;17:1771848. doi: 10.3389/fimmu.2026.1771848. eCollection 2026. | |
| 41787239 |
Not provided
Not provided
Data will be shared after study completion via publication.
Not provided
Not provided
Not provided
Not provided
A total of 646 participants were screened and of those, 549 were enrolled and randomized to receive either ublituximab/oral placebo or teriflunomide/IV placebo.
A total of 549 participants were enrolled across investigative sites in Belarus, Spain, the United Kingdom, Georgia, Poland, Russia, Serbia, Ukraine, and the United States from 19 September 2017 to 6 November 2020.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ublituximab + Oral Placebo | Participants were administered ublituximab 150 milligrams (mg), intravenous (IV) infusion over 4 hours (h) on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo once daily (QD) from Day 1 up to the last day of Week 95. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 4, 2020 | Nov 3, 2021 |
Not provided
Randomized, multi-center, double-blinded, active-controlled study
Not provided
Not provided
Double-blinded, active-controlled study
| Teriflunomide | Drug | Film-coated tablets administered orally. |
|
| Oral Placebo | Drug | Administered orally. |
|
| IV Placebo | Drug | Administered as an IV infusion. |
|
| Total Number of New and Enlarging T2 Hyperintense Lesions (NELs) Per MRI Scan Per Participant |
The total number of NELs were calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96, divided by the total number of MRI scans of the brain. |
| Weeks 24, 48, and 96 |
| Time to Confirmed Disability Progression (CDP) for at Least 12 Weeks | 12-week CDP is defined as an increase in EDSS at least 1 point higher than the baseline EDSS if the baseline EDSS is ≤5.5 or at least 0.5 higher than the baseline EDSS if the baseline EDSS is >5.5. The EDSS is based on a standard neurological examination, (pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, and cerebral) and ambulation function system assessments. The EDSS disability scale ranges in 0.5-point steps from 0 (normal) to 10 (death) where higher scores indicate disability. The time to onset of 12-week CDP is the time to progression to the EDSS change defined above. | Up to Week 96 |
| Percentage of Participants With No Evidence of Disease Activity (NEDA) | A participant with NEDA is defined as a participant without relapses confirmed by the IRAP, without MRI activities (no T1 Gd+ lesions and no new/enlarging T2 lesions), and no 12-week CDP. Any evidence of disease activity from Week 24 to Week 96 was counted as not reaching NEDA. Any evidence of disease activity before Week 24 was not counted. | Week 24 up to Week 96 |
| Percentage of Participants With Impaired Symbol Digit Modalities Test (SDMT) | The SDMT involves a simple substitution task using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Responses are done verbally. The administration time is approximately 5 minutes. The total SDMT score for each visit ranging from 0-110 is defined as the total number of correct answers reported in the case report form (CRF), where high scores indicate better outcome. Impaired SDMT is defined as a decrease from baseline of at least 4 points at any post-baseline assessment up to the Week 96 visit. | Baseline up to Week 96 |
| Percent Change From Baseline in Brain Volume | Baseline up to Week 96 |
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A Serious AE is defined as any untoward medical occurrence that: results in death, is immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, and/or causes a congenital anomaly/birth defect. A TEAE is an AE that starts or worsens after receiving study drug. | From the first dose of study drug through the end of the study (up to approximately 116 weeks) |
| Long Beach |
| California |
| 90808 |
| United States |
| TG Therapeutics RMS Investigational Trial Site | Pasadena | California | 91105 | United States |
| TG Therapeutics RMS Investigational Trial Site | Stanford | California | 94305 | United States |
| TG Therapeutics RMS Investigational Trial Site | Miami | Florida | 33136 | United States |
| TG Therapeutics RMS Investigational Trial Site | Northbrook | Illinois | 60062 | United States |
| TG Therapeutics RMS Investigational Trial Site | Kansas City | Kansas | 66160 | United States |
| TG Therapeutics RMS Investigational Trial Site | Detroit | Michigan | 48201 | United States |
| TG Therapeutics RMS Investigational Trial Site | Amherst | New York | 14226 | United States |
| TG Therapeutics RMS Investigational Trial Site | Westerville | Ohio | 43081 | United States |
| TG Therapeutics RMS Investigational Trial Site | Franklin | Tennessee | 37064 | United States |
| TG Therapeutics RMS Investigational Trial Site | Knoxville | Tennessee | 37922 | United States |
| TG Therapeutics RMS Investigational Trial Site | Dallas | Texas | 75246 | United States |
| TG Therapeutics RMS Investigational Site | Round Rock | Texas | 78681 | United States |
| Derived |
| Hartung HP, Robertson D, Steinman L, Arnold DL, Qian P, Wray S, Fox E, Garner CA, Xu Y, Mok K, Gocke A, Cree BAC, Alvarez E. Efficacy of Ublituximab in People with Highly Active Relapsing Multiple Sclerosis. Neurol Ther. 2026 Jun;15(3):1081-1097. doi: 10.1007/s40120-026-00904-4. Epub 2026 Mar 6. |
| 39512280 | Derived | Alvarez E, Steinman L, Fox EJ, Hartung HP, Qian P, Wray S, Robertson D, Selmaj K, Wynn D, Mok K, Xu Y, Bodhinathan K, Miskin HP, Cree BAC. Improvements in no evidence of disease activity with ublituximab vs. teriflunomide in the ULTIMATE phase 3 studies in relapsing multiple sclerosis. Front Neurol. 2024 Oct 24;15:1473284. doi: 10.3389/fneur.2024.1473284. eCollection 2024. |
| 36001711 | Derived | Steinman L, Fox E, Hartung HP, Alvarez E, Qian P, Wray S, Robertson D, Huang D, Selmaj K, Wynn D, Cutter G, Mok K, Hsu Y, Xu Y, Weiss MS, Bosco JA, Power SA, Lee L, Miskin HP, Cree BAC; ULTIMATE I and ULTIMATE II Investigators. Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis. N Engl J Med. 2022 Aug 25;387(8):704-714. doi: 10.1056/NEJMoa2201904. |
| Teriflunomide + IV Placebo |
Participants were administered teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72). |
| COMPLETED | The completed number of participants denote the population who completed the 96 weeks Treatment Period. |
|
| NOT COMPLETED |
|
|
Intention-to-Treat (ITT) population consisted of all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ublituximab + Oral Placebo | Participants were administered ublituximab 150 mg, IV infusion over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo QD from Day 1 up to the last day of Week 95. |
| BG001 | Teriflunomide + IV Placebo | Participants were administered teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Annualized Relapse Rate (ARR) | ARR is defined as the number of Independent Relapse Adjudication Panel (IRAP)-confirmed relapses per participant year. The estimate of ARR for a treatment group is the total number of relapses for participants in the respective treatment group divided by the sum of treatment duration for participants in that specific treatment group. | Modified Intention-to-Treat (mITT) population consisted of all participants in the ITT population who received at least one dose of study medication and have at least one baseline and post baseline efficacy assessment. | Posted | Least Squares Mean | 95% Confidence Interval | relapses per participant-years | Up to 96 weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Number of Gadolinium (Gd)-Enhancing T1-Lesions Per Magnetic Resonance Imaging (MRI) Scan Per Participant | The total number of Gd-enhancing T1-lesions were calculated as the sum of the individual number of lesions at Weeks 12, 24, 48, and 96, divided by the total number of MRI scans of the brain. | mITT- magnetic resonance imaging (MRI) population included participants in mITT population who have baseline and post-baseline MRI efficacy assessments. Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | lesions per scan per participant | Weeks 12, 24, 48, and 96 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Number of New and Enlarging T2 Hyperintense Lesions (NELs) Per MRI Scan Per Participant | The total number of NELs were calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96, divided by the total number of MRI scans of the brain. | mITT- MRI population included participants in mITT population who have baseline and post-baseline MRI efficacy assessments. Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | lesions per scan per participant | Weeks 24, 48, and 96 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Confirmed Disability Progression (CDP) for at Least 12 Weeks | 12-week CDP is defined as an increase in EDSS at least 1 point higher than the baseline EDSS if the baseline EDSS is ≤5.5 or at least 0.5 higher than the baseline EDSS if the baseline EDSS is >5.5. The EDSS is based on a standard neurological examination, (pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, and cerebral) and ambulation function system assessments. The EDSS disability scale ranges in 0.5-point steps from 0 (normal) to 10 (death) where higher scores indicate disability. The time to onset of 12-week CDP is the time to progression to the EDSS change defined above. | mITT population consisted of all participants in the ITT population who received at least one dose of study medication and have at least one baseline and post baseline efficacy assessment. As per protocol, data was summarized for the mITT Population using pooled data from participants in this study and TG1101-RMS302 [NCT03277248]. | Posted | Median | Inter-Quartile Range | weeks | Up to Week 96 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With No Evidence of Disease Activity (NEDA) | A participant with NEDA is defined as a participant without relapses confirmed by the IRAP, without MRI activities (no T1 Gd+ lesions and no new/enlarging T2 lesions), and no 12-week CDP. Any evidence of disease activity from Week 24 to Week 96 was counted as not reaching NEDA. Any evidence of disease activity before Week 24 was not counted. | mITT population consisted of all participants in the ITT population who received at least one dose of study medication and have at least one baseline and post baseline efficacy assessment. | Posted | Number | percentage of participants | Week 24 up to Week 96 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Impaired Symbol Digit Modalities Test (SDMT) | The SDMT involves a simple substitution task using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Responses are done verbally. The administration time is approximately 5 minutes. The total SDMT score for each visit ranging from 0-110 is defined as the total number of correct answers reported in the case report form (CRF), where high scores indicate better outcome. Impaired SDMT is defined as a decrease from baseline of at least 4 points at any post-baseline assessment up to the Week 96 visit. | mITT population consisted of all participants in the ITT population who received at least one dose of study medication and have at least one baseline and post baseline efficacy assessment. | Posted | Number | percentage of participants | Baseline up to Week 96 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Brain Volume | mITT- MRI population included participants in mITT population who have baseline and post-baseline MRI efficacy assessments. Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | percent change | Baseline up to Week 96 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A Serious AE is defined as any untoward medical occurrence that: results in death, is immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, and/or causes a congenital anomaly/birth defect. A TEAE is an AE that starts or worsens after receiving study drug. | Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos). | Posted | Number | percentage of participants | From the first dose of study drug through the end of the study (up to approximately 116 weeks) |
|
From the first dose of study drug through the end of the study (up to approximately 116 weeks)
All-Cause Mortality: All the enrolled participants; Adverse Events: Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ublituximab + Oral Placebo | Participants were administered ublituximab 150 mg, IV infusion over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo QD from Day 1 up to the last day of Week 95. | 2 | 274 | 31 | 273 | 197 | 273 |
| EG001 | Teriflunomide + IV Placebo | Participants were administered teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72). | 0 | 275 | 19 | 275 | 181 | 275 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Oesophageal achalasia | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Central nervous system enteroviral infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Bullous erysipelas | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Measles | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Meningoencephalitis viral | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Salpingitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Lyme disease | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Neurological symptom | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Acoustic neuritis | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (23.0) | Systematic Assessment |
| |
| Affective disorder | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Medical device removal | Surgical and medical procedures | MedDRA (23.0) | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| TG Therapeutics Clinical Support Team | TG Therapeutics | 1-877-575-8489 | clinicalsupport@tgtxinc.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 4, 2020 | Nov 3, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000619007 | ublituximab |
| C527525 | teriflunomide |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| White |
|
| Native Hawaiian or Other Pacific Islander |
|
| Other |
|
| Participants |
|
|
|
| Participants |
|
|
|
|
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| Participants |
|
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| Units | Counts |
|---|---|
| Participants |
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