Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000501-93 | EudraCT Number |
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Sponsor decision
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This study was designed to evaluate the long-term safety of daily oral treatment with BCX9930 in participants who had participated in a previous BCX9930 trial for PNH and showed a benefit of treatment as determined by the Investigator. The study allowed continued access to BCX9930 for enrolled participants. The study also evaluated the long-term effectiveness and impact on quality of life and general well-being of BCX9930 treatment, and the participant's satisfaction with the medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complement Component 5 (C5) Inhibitor (C5-INH) Naïve Group | Experimental | This group included participants who, prior to enrolling in their previous BCX9930 study, were either naïve to eculizumab or ravulizumab treatment, or naive to treatment with any complement inhibitor therapy (or had received no treatment in the prior 12 months), and with anemia due to ongoing intravascular hemolysis. |
|
| C5 INH Inadequate Response Group | Experimental | This group included participants who, prior to enrolling in their previous BCX9930 study, were receiving stable treatment with eculizumab or ravulizumab and had an inadequate response to that therapy (ie, residual anemia and/or ongoing need for transfusion). Depending on the prior study, participants may have continued the C5 inhibitor, with BCX9930 provided as an add-on therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCX9930 | Drug | BCX9930 for oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An AE was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related in a participant or clinical investigation participant who administered a pharmaceutical product regardless of its causal relationship to the study treatment. An AE was considered treatment-emergent if its start date and time was on or after the date and time of first on-study dose of study drug. | From first dose of study drug up to 3 weeks after last dose (Week 147) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical PNH Symptom Based on Severity: Fatigue | Data was reported for number of participants with clinical PNH symptom of fatigue. The severity of clinical PNH symptom of fatigue was graded as none, mild, moderate and severe based solely on investigator's discretion. | Baseline, Weeks 24, 48, 72, 96, and 120 |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol-defined Inclusion/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Morag Griffin, MBChB | Leeds Teaching Hospitals NHS Trust, Leeds, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Center | Vienna | Austria | ||||
| Study Center |
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Participants who had participated in previous BCX9930 trials (BCX9930-101 [NCT04330534], BCX9930-202 [NCT05116774], or BCX9930-203 [NCT05116787]) for Paroxysmal Nocturnal Hemoglobinuria (PNH) and showed a benefit of treatment as determined by the investigator were enrolled in this long-term safety trial.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Complement Component 5 (C5) Inhibitor (C5-INH) Naïve Group | This group included participants who, prior to enrolling in their previous BCX9930 study, were either naïve to eculizumab or ravulizumab treatment, or naive to treatment with any complement inhibitor therapy (or had received no treatment in the prior 12 months), and with anemia due to ongoing intravascular hemolysis. Participants were to commence treatment at the same BCX9930 dose level and regimen last administered to that individual in the prior study. Per last protocol amendment, all participants received BCX9930 400 milligrams (mg) orally twice daily (BID). Treatment duration was up to 144 weeks. |
| FG001 | C5-INH Inadequate Response Group | This group included participants who, prior to enrolling in their previous BCX9930 study, were receiving stable treatment with eculizumab or ravulizumab and had an inadequate response to that therapy (ie, residual anemia and/or ongoing need for transfusion). Depending on the prior study, participants may have continued the C5 inhibitor, with BCX9930 provided as an add-on therapy. Participants were to commence treatment at the same BCX9930 dose level and regimen last administered to that individual in the prior study. Per last protocol amendment, all participants received BCX9930 400 mg orally BID. Treatment duration was up to 144 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The safety population included all participants who received at least 1 capsule or tablet of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | C5-INH Naïve Group | This group included participants who, prior to enrolling in their previous BCX9930 study, were either naïve to eculizumab or ravulizumab treatment, or naive to treatment with any complement inhibitor therapy (or had received no treatment in the prior 12 months), and with anemia due to ongoing intravascular hemolysis. Participants were to commence treatment at the same BCX9930 dose level and regimen last administered to that individual in the prior study. Per last protocol amendment, all participants received BCX9930 400 mg orally BID. Treatment duration was up to 144 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An AE was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related in a participant or clinical investigation participant who administered a pharmaceutical product regardless of its causal relationship to the study treatment. An AE was considered treatment-emergent if its start date and time was on or after the date and time of first on-study dose of study drug. | The safety population included all participants who received at least 1 capsule or tablet of study drug. | Posted | Count of Participants | Participants | From first dose of study drug up to 3 weeks after last dose (Week 147) |
|
From first dose of study drug up to 3 weeks after last dose (Week 147)
The safety analysis population included all participants who received at least 1 capsule or tablet of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Complement Component 5 (C5) Inhibitor (C5-INH) Naïve Group | This group included participants who, prior to enrolling in their previous BCX9930 study, were either naïve to eculizumab or ravulizumab treatment, or naive to treatment with any complement inhibitor therapy (or had received no treatment in the prior 12 months), and with anemia due to ongoing intravascular hemolysis. Participants were to commence treatment at the same BCX9930 dose level and regimen last administered to that individual in the prior study. Per last protocol amendment, all participants received BCX9930 400 mg orally BID. Treatment duration was up to 144 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breakthrough haemolysis | Blood and lymphatic system disorders | MedDRA Version 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
The sponsor decided to prematurely terminate the study due to business reasons. Per change in planned analysis, data were analyzed and reported for safety and selected efficacy parameters (assessment of various clinical PNH symptoms severity, incidence of thromboembolic events, change from baseline in clinical measurements of PNH [LDH, hemoglobin, haptoglobin, reticulocytes, transfusion requirements], and change from baseline in FACIT]).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | BioCryst Pharmaceuticals Inc | +1 919-859-1302 | clinicaltrials@biocryst.com |
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 | Jul 1, 2022 | Oct 3, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 24, 2023 | Oct 3, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006457 | Hemoglobinuria, Paroxysmal |
| ID | Term |
|---|---|
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C481642 | eculizumab |
| C000629409 | ravulizumab |
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| Eculizumab | Drug | Administered at stable dose at the time of study entry |
|
| Ravulizumab | Drug | Administered at stable dose at the time of study entry |
|
| Number of Participants With Clinical PNH Symptom Based on Severity: Dyspnea |
Data was reported for number of participants with clinical PNH symptom of Dyspnea. The severity of clinical PNH symptom of Dyspnea was graded as none, mild, moderate and severe based solely on investigator's discretion. |
| Baseline, Weeks 24, 48, 72, 96, and 120 |
| Number of Participants With Clinical PNH Symptom Based on Severity: Chest Pain/Discomfort | Data was reported for number of participants with clinical PNH symptom of Chest pain/discomfort. The severity of clinical PNH symptom of chest pain/discomfort was graded as none, mild, moderate and severe based solely on investigator's discretion. | Baseline, Weeks 24, 48, 72, 96, and 120 |
| Number of Participants With Clinical PNH Symptom Based on Severity: Difficulty Swallowing | Data was reported for number of participants with clinical PNH symptom of difficulty swallowing. The severity of clinical PNH symptom of difficulty swallowing was graded as none, mild, moderate and severe based solely on investigator's discretion. | Baseline, Weeks 24, 48, 72, 96, and 120 |
| Number of Participants With Clinical PNH Symptom Based on Severity: Abdominal Pain | Data was reported for number of participants with clinical PNH symptom of abdominal pain. The severity of clinical PNH symptom of abdominal pain was graded as none, mild, moderate and severe based solely on investigator's discretion. | Baseline, Weeks 24, 48, 72, 96, and 120 |
| Number of Participants With Clinical PNH Symptom Based on Severity: Headache | Data was reported for number of participants with clinical PNH symptom of headache. The severity of clinical PNH symptom of headache was graded as none, mild, moderate and severe based solely on investigator's discretion. | Baseline, Weeks 24, 48, 72, 96, and 120 |
| Number of Participants With Clinical PNH Symptom Based on Severity: Erectile Dysfunction | Data was reported for number of participants with clinical PNH symptom of erectile dysfunction. The severity of clinical PNH symptom of erectile dysfunction was graded as none, mild, moderate and severe based solely on investigator's discretion. | Baseline, Weeks 24, 48, 72, 96, and 120 |
| Number of Participants With Clinical PNH Symptom Based on Severity: Hemoglobinuria | Data was reported for number of participants with clinical PNH symptom of Hemoglobinuria.The severity of clinical PNH symptom of hemoglobinuria was graded as none, mild, moderate and severe based solely on investigator's discretion. | Baseline, Weeks 24, 48, 72, 96, and 120 |
| Number of Participants With Clinical PNH Symptom Based on Severity: Jaundice | Data was reported for number of participants with clinical PNH symptom of jaundice. The severity of clinical PNH symptom of jaundice was graded as none, mild, moderate and severe based solely on investigator's discretion. | Baseline, Weeks 24, 48, 72, 96, and 120 |
| Change From Baseline in Lactate Dehydrogenase (LDH) | Baseline, Weeks, 24, 48, 72, 96, 120, and 144 |
| Change From Baseline in Hemoglobin | Baseline, Weeks 24, 48, 72, 96, 120, and 144 |
| Change From Baseline in Haptoglobin | Baseline, Weeks 24, 48, 72, 96, and 120 |
| Change From Baseline in Reticulocytes | Baseline, Weeks 24, 48, 72, 96, and 120 |
| Number of Participants With Blood Transfusions or Thromboses | Data was reported for number of participants for whom blood transfusion was required or who experienced the thrombosis events. | From first dose of study drug up to 3 weeks after last dose (Week 147) |
| Number of Blood Transfusions | Number of blood transfusions were reported. | From first dose of study drug up to 3 weeks after last dose (Week 147) |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Total Score | The FACIT-Fatigue scale questionnaire was used to determine the level of fatigue experienced by participants. This questionnaire was a 13-item measure that assessed self-reported fatigue and its impact upon daily activities and function. Item scores ranged from 0 ("not at all") to 4 ("very much"), and the total score ranged from 0 to 52, with higher scores indicating greater quality of life. | Baseline, Weeks 24, 48, 72, and 96 |
| Bloemfontein |
| South Africa |
| Study Center | Cape Town | South Africa |
| Study Center | Pretoria | South Africa |
| Study Center | London | United Kingdom |
| Bone marrow transplant |
|
| Withdrawn due to Investigator decision |
|
| Withdrawal by Subject |
|
| BG001 | C5-INH Inadequate Response Group | This group included participants who, prior to enrolling in their previous BCX9930 study, were receiving stable treatment with eculizumab or ravulizumab and had an inadequate response to that therapy (ie, residual anemia and/or ongoing need for transfusion). Depending on the prior study, participants may have continued the C5 inhibitor, with BCX9930 provided as an add-on therapy. Participants were to commence treatment at the same BCX9930 dose level and regimen last administered to that individual in the prior study. Per last protocol amendment, all participants received BCX9930 400 mg orally BID. Treatment duration was up to 144 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | C5-INH Inadequate Response Group | This group included participants who, prior to enrolling in their previous BCX9930 study, were receiving stable treatment with eculizumab or ravulizumab and had an inadequate response to that therapy (ie, residual anemia and/or ongoing need for transfusion). Depending on the prior study, participants may have continued the C5 inhibitor, with BCX9930 provided as an add-on therapy. Participants were to commence treatment at the same BCX9930 dose level and regimen last administered to that individual in the prior study. Per last protocol amendment, all participants received BCX9930 400 mg orally BID. Treatment duration was up to 144 weeks. |
|
|
| Secondary | Number of Participants With Clinical PNH Symptom Based on Severity: Fatigue | Data was reported for number of participants with clinical PNH symptom of fatigue. The severity of clinical PNH symptom of fatigue was graded as none, mild, moderate and severe based solely on investigator's discretion. | The mITT (modified intent-to-treat) population included all participants who received at least 1 capsule or tablet of study drug and had post baseline assessment of PNH symptoms and/or laboratory data. Participants with available data at each visit were included. | Posted | Count of Participants | Participants | Baseline, Weeks 24, 48, 72, 96, and 120 |
|
|
|
| Secondary | Number of Participants With Clinical PNH Symptom Based on Severity: Dyspnea | Data was reported for number of participants with clinical PNH symptom of Dyspnea. The severity of clinical PNH symptom of Dyspnea was graded as none, mild, moderate and severe based solely on investigator's discretion. | Participants in the mITT population with available data were analyzed. | Posted | Count of Participants | Participants | Baseline, Weeks 24, 48, 72, 96, and 120 |
|
|
|
| Secondary | Number of Participants With Clinical PNH Symptom Based on Severity: Chest Pain/Discomfort | Data was reported for number of participants with clinical PNH symptom of Chest pain/discomfort. The severity of clinical PNH symptom of chest pain/discomfort was graded as none, mild, moderate and severe based solely on investigator's discretion. | Participants in the mITT population with available data were analyzed. | Posted | Count of Participants | Participants | Baseline, Weeks 24, 48, 72, 96, and 120 |
|
|
|
| Secondary | Number of Participants With Clinical PNH Symptom Based on Severity: Difficulty Swallowing | Data was reported for number of participants with clinical PNH symptom of difficulty swallowing. The severity of clinical PNH symptom of difficulty swallowing was graded as none, mild, moderate and severe based solely on investigator's discretion. | Participants in the mITT population with available data were analyzed. | Posted | Count of Participants | Participants | Baseline, Weeks 24, 48, 72, 96, and 120 |
|
|
|
| Secondary | Number of Participants With Clinical PNH Symptom Based on Severity: Abdominal Pain | Data was reported for number of participants with clinical PNH symptom of abdominal pain. The severity of clinical PNH symptom of abdominal pain was graded as none, mild, moderate and severe based solely on investigator's discretion. | Participants in the mITT population with available data were analyzed. | Posted | Count of Participants | Participants | Baseline, Weeks 24, 48, 72, 96, and 120 |
|
|
|
| Secondary | Number of Participants With Clinical PNH Symptom Based on Severity: Headache | Data was reported for number of participants with clinical PNH symptom of headache. The severity of clinical PNH symptom of headache was graded as none, mild, moderate and severe based solely on investigator's discretion. | Participants in the mITT population with available data were analyzed. | Posted | Count of Participants | Participants | Baseline, Weeks 24, 48, 72, 96, and 120 |
|
|
|
| Secondary | Number of Participants With Clinical PNH Symptom Based on Severity: Erectile Dysfunction | Data was reported for number of participants with clinical PNH symptom of erectile dysfunction. The severity of clinical PNH symptom of erectile dysfunction was graded as none, mild, moderate and severe based solely on investigator's discretion. | Participants in the mITT population with available data were analyzed. | Posted | Count of Participants | Participants | Baseline, Weeks 24, 48, 72, 96, and 120 |
|
|
|
| Secondary | Number of Participants With Clinical PNH Symptom Based on Severity: Hemoglobinuria | Data was reported for number of participants with clinical PNH symptom of Hemoglobinuria.The severity of clinical PNH symptom of hemoglobinuria was graded as none, mild, moderate and severe based solely on investigator's discretion. | Participants in the mITT population with available data were analyzed. | Posted | Count of Participants | Participants | Baseline, Weeks 24, 48, 72, 96, and 120 |
|
|
|
| Secondary | Number of Participants With Clinical PNH Symptom Based on Severity: Jaundice | Data was reported for number of participants with clinical PNH symptom of jaundice. The severity of clinical PNH symptom of jaundice was graded as none, mild, moderate and severe based solely on investigator's discretion. | Participants in the population with available data were analyzed. | Posted | Count of Participants | Participants | Baseline, Weeks 24, 48, 72, 96, and 120 |
|
|
|
| Secondary | Change From Baseline in Lactate Dehydrogenase (LDH) | Participants in the mITT population with available data were analyzed. | Posted | Mean | Standard Deviation | Units per liter (U/L) | Baseline, Weeks, 24, 48, 72, 96, 120, and 144 |
|
|
|
| Secondary | Change From Baseline in Hemoglobin | Participants in the mITT population with available data were analyzed. | Posted | Mean | Standard Deviation | grams per deciliter (g/dl) | Baseline, Weeks 24, 48, 72, 96, 120, and 144 |
|
|
|
| Secondary | Change From Baseline in Haptoglobin | Participants in the mITT population with available data were analyzed. | Posted | Mean | Standard Deviation | grams per liter (g/L) | Baseline, Weeks 24, 48, 72, 96, and 120 |
|
|
|
| Secondary | Change From Baseline in Reticulocytes | Participants in the mITT population with available data were analyzed | Posted | Mean | Standard Deviation | 10^6 cells per microliter (μL) | Baseline, Weeks 24, 48, 72, 96, and 120 |
|
|
|
| Secondary | Number of Participants With Blood Transfusions or Thromboses | Data was reported for number of participants for whom blood transfusion was required or who experienced the thrombosis events. | Participants in the mITT population with available data were analyzed. | Posted | Count of Participants | Participants | From first dose of study drug up to 3 weeks after last dose (Week 147) |
|
|
|
| Secondary | Number of Blood Transfusions | Number of blood transfusions were reported. | Participants from mITT population who required blood transfusions. | Posted | Number | Number of blood transfusions | From first dose of study drug up to 3 weeks after last dose (Week 147) |
|
|
|
| Secondary | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Total Score | The FACIT-Fatigue scale questionnaire was used to determine the level of fatigue experienced by participants. This questionnaire was a 13-item measure that assessed self-reported fatigue and its impact upon daily activities and function. Item scores ranged from 0 ("not at all") to 4 ("very much"), and the total score ranged from 0 to 52, with higher scores indicating greater quality of life. | Participants in the mITT population with available data were analyzed. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Weeks 24, 48, 72, and 96 |
|
|
|
| 0 |
| 12 |
| 6 |
| 12 |
| 12 |
| 12 |
| EG001 | C5-INH Inadequate Response Group | This group included participants who, prior to enrolling in their previous BCX9930 study, were receiving stable treatment with eculizumab or ravulizumab and had an inadequate response to that therapy (ie, residual anemia and/or ongoing need for transfusion). Depending on the prior study, participants may have continued the C5 inhibitor, with BCX9930 provided as an add-on therapy. Participants were to commence treatment at the same BCX9930 dose level and regimen last administered to that individual in the prior study. Per last protocol amendment, all participants received BCX9930 400 mg orally BID. Treatment duration was up to 144 weeks. | 0 | 7 | 3 | 7 | 7 | 7 |
| Haemolysis | Blood and lymphatic system disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Boutonneuse fever | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
|
| Soft tissue infection | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Epstein-Barr virus associated lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
|
| Rhinovirus infection | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
|
| Bacterial vaginosis | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
|
| Genital herpes | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
|
| Helicobacter gastritis | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
|
| Soft tissue infection | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Breakthrough haemolysis | Blood and lymphatic system disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Haemolysis | Blood and lymphatic system disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Splenomegaly | Blood and lymphatic system disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA Version 24.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA Version 24.0 | Systematic Assessment |
|
| Urine albumin/creatinine ratio increased | Investigations | MedDRA Version 24.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA Version 24.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA Version 24.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA Version 24.0 | Systematic Assessment |
|
| Blood iron decreased | Investigations | MedDRA Version 24.0 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA Version 24.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA Version 24.0 | Systematic Assessment |
|
| Creatinine urine increased | Investigations | MedDRA Version 24.0 | Systematic Assessment |
|
| Fibrin D dimer increased | Investigations | MedDRA Version 24.0 | Systematic Assessment |
|
| Glomerular filtration rate decreased | Investigations | MedDRA Version 24.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA Version 24.0 | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA Version 24.0 | Systematic Assessment |
|
| SARS-CoV-2 test positive | Investigations | MedDRA Version 24.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA Version 24.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Ageusia | Nervous system disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Folate deficiency | Metabolism and nutrition disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Painful respiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Sinus pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Axillary pain | General disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Haemoglobinuria | Renal and urinary disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA Version 24.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 24.0 | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA Version 24.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA Version 24.0 | Systematic Assessment |
|
| Maternal exposure via partner during pregnancy | Injury, poisoning and procedural complications | MedDRA Version 24.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Pityriasis rosea | Skin and subcutaneous tissue disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Ear haemorrhage | Ear and labyrinth disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Tympanic membrane disorder | Ear and labyrinth disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Vasculitis | Vascular disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA Version 24.0 | Systematic Assessment |
|
Not provided
Not provided
| D009190 |
| Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |
| Baseline-mild |
|
|
| Baseline-moderate |
|
|
| Baseline-severe |
|
|
| Week 24-none |
|
|
| Week 24-mild |
|
|
| Week 24-moderate |
|
|
| Week 24-severe |
|
|
| Week 48-none |
|
|
| Week 48-mild |
|
|
| Week 48-moderate |
|
|
| Week 48-severe |
|
|
| Week 72-none |
|
|
| Week 72-mild |
|
|
| Week 72-moderate |
|
|
| Week 72-severe |
|
|
| Week 96-none |
|
|
| Week 96-mild |
|
|
| Week 96-moderate |
|
|
| Week 96-severe |
|
|
| Week 120-none |
|
|
| Week 120-mild |
|
|
| Week 120-moderate |
|
|
| Week 120-severe |
|
|
| Baseline-mild |
|
|
| Baseline-moderate |
|
|
| Baseline-severe |
|
|
| Week 24-none |
|
|
| Week 24-mild |
|
|
| Week 24-moderate |
|
|
| Week 24-severe |
|
|
| Week 48-none |
|
|
| Week 48-mild |
|
|
| Week 48-moderate |
|
|
| Week 48-severe |
|
|
| Week 72-none |
|
|
| Week 72-mild |
|
|
| Week 72-moderate |
|
|
| Week 72-severe |
|
|
| Week 96-none |
|
|
| Week 96-mild |
|
|
| Week 96-moderate |
|
|
| Week 96-severe |
|
|
| Week 120-none |
|
|
| Week 120-mild |
|
|
| Week 120-moderate |
|
|
| Week 120-severe |
|
|
| Baseline-mild |
|
|
| Baseline-moderate |
|
|
| Baseline-severe |
|
|
| Week 24-none |
|
|
| Week 24-mild |
|
|
| Week 24-moderate |
|
|
| Week 24-severe |
|
|
| Week 48-none |
|
|
| Week 48-mild |
|
|
| Week 48-moderate |
|
|
| Week 48-severe |
|
|
| Week 72-none |
|
|
| Week 72-mild |
|
|
| Week 72-moderate |
|
|
| Week 72-severe |
|
|
| Week 96-none |
|
|
| Week 96-mild |
|
|
| Week 96-moderate |
|
|
| Week 96-severe |
|
|
| Week 120-none |
|
|
| Week 120-mild |
|
|
| Week 120-moderate |
|
|
| Week 120-severe |
|
|
| Baseline-mild |
|
|
| Baseline-moderate |
|
|
| Baseline-severe |
|
|
| Week 24-none |
|
|
| Week 24-mild |
|
|
| Week 24-moderate |
|
|
| Week 24-severe |
|
|
| Week 48-none |
|
|
| Week 48-mild |
|
|
| Week 48-moderate |
|
|
| Week 48-severe |
|
|
| Week 72-none |
|
|
| Week 72-mild |
|
|
| Week 72-moderate |
|
|
| Week 72-severe |
|
|
| Week 96-none |
|
|
| Week 96-mild |
|
|
| Week 96-moderate |
|
|
| Week 96-severe |
|
|
| Week 120-none |
|
|
| Week 120-mild |
|
|
| Week 120-moderate |
|
|
| Week 120-severe |
|
|
| Baseline-mild |
|
|
| Baseline-moderate |
|
|
| Baseline-severe |
|
|
| Week 24-none |
|
|
| Week 24-mild |
|
|
| Week 24-moderate |
|
|
| Week 24-severe |
|
|
| Week 48-none |
|
|
| Week 48-mild |
|
|
| Week 48-moderate |
|
|
| Week 48-severe |
|
|
| Week 72-none |
|
|
| Week 72-mild |
|
|
| Week 72-moderate |
|
|
| Week 72-severe |
|
|
| Week 96-none |
|
|
| Week 96-mild |
|
|
| Week 96-moderate |
|
|
| Week 96-severe |
|
|
| Week 120-none |
|
|
| Week 120-mild |
|
|
| Week 120-moderate |
|
|
| Week 120-severe |
|
|
| Baseline-mild |
|
|
| Baseline-moderate |
|
|
| Baseline-severe |
|
|
| Week 24-none |
|
|
| Week 24-mild |
|
|
| Week 24-moderate |
|
|
| Week 24-severe |
|
|
| Week 48-none |
|
|
| Week 48-mild |
|
|
| Week 48-moderate |
|
|
| Week 48-severe |
|
|
| Week 72-none |
|
|
| Week 72-mild |
|
|
| Week 72-moderate |
|
|
| Week 72-severe |
|
|
| Week 96-none |
|
|
| Week 96-mild |
|
|
| Week 96-moderate |
|
|
| Week 96-severe |
|
|
| Week 120-none |
|
|
| Week 120-mild |
|
|
| Week 120-moderate |
|
|
| Week 120-severe |
|
|
| Baseline-mild |
|
|
| Baseline-moderate |
|
|
| Baseline-severe |
|
|
| Week 24-none |
|
|
| Week 24-mild |
|
|
| Week 24-moderate |
|
|
| Week 24-severe |
|
|
| Week 48-none |
|
|
| Week 48-mild |
|
|
| Week 48-moderate |
|
|
| Week 48-severe |
|
|
| Week 72-none |
|
|
| Week 72-mild |
|
|
| Week 72-moderate |
|
|
| Week 72-severe |
|
|
| Week 96-none |
|
|
| Week 96-mild |
|
|
| Week 96-moderate |
|
|
| Week 96-severe |
|
|
| Week 120-none |
|
|
| Week 120-mild |
|
|
| Week 120-moderate |
|
|
| Week 120-severe |
|
|
| Baseline-mild |
|
|
| Baseline-moderate |
|
|
| Baseline-severe |
|
|
| Baseline-missing severity |
|
|
| Week 24-none |
|
|
| Week 24-mild |
|
|
| Week 24-moderate |
|
|
| Week 24-severe |
|
|
| Week 24-missing severity |
|
|
| Week 48-none |
|
|
| Week 48-mild |
|
|
| Week 48-moderate |
|
|
| Week 48-severe |
|
|
| Week 48-missing severity |
|
|
| Week 72-none |
|
|
| Week 72-mild |
|
|
| Week 72-moderate |
|
|
| Week 72-severe |
|
|
| Week 72-missing severity |
|
|
| Week 96-none |
|
|
| Week 96-mild |
|
|
| Week 96-moderate |
|
|
| Week 96-severe |
|
|
| Week 96-missing severity |
|
|
| Week 120-none |
|
|
| Week 120-mild |
|
|
| Week 120-moderate |
|
|
| Week 120-severe |
|
|
| Week 120-missing severity |
|
|
| Baseline-mild |
|
|
| Baseline-moderate |
|
|
| Baseline-severe |
|
|
| Baseline-missing severity |
|
|
| Week 24-none |
|
|
| Week 24-mild |
|
|
| Week 24-moderate |
|
|
| Week 24-severe |
|
|
| Week 48-none |
|
|
| Week 48-mild |
|
|
| Week 48-moderate |
|
|
| Week 48-severe |
|
|
| Week 72-none |
|
|
| Week 72-mild |
|
|
| Week 72-moderate |
|
|
| Week 72-severe |
|
|
| Week 96-none |
|
|
| Week 96-mild |
|
|
| Week 96-moderate |
|
|
| Week 96-severe |
|
|
| Week 120-none |
|
|
| Week 120-mild |
|
|
| Week 120-moderate |
|
|
| Week 120-severe |
|
|
| Change at Week 24 |
|
|
| Change at Week 48 |
|
|
| Change at Week 72 |
|
|
| Change at Week 96 |
|
|
| Change at Week 120 |
|
|
| Change at Week 144 |
|
|
| Change at Week 24 |
|
|
| Change at Week 48 |
|
|
| Change at Week 72 |
|
|
| Change at Week 96 |
|
|
| Change at Week 120 |
|
|
| Change at Week 144 |
|
|
| Change at Week 24 |
|
|
| Change at Week 48 |
|
|
| Change at Week 72 |
|
|
| Change at Week 96 |
|
|
| Change at Week 120 |
|
|
| Change at Week 24 |
|
|
| Change at Week 48 |
|
|
| Change at Week 72 |
|
|
| Change at Week 96 |
|
|
| Change at Week 120 |
|
|
| Change at Week 24 |
|
|
| Change at Week 48 |
|
|
| Change at Week 72 |
|
|
| Change at Week 96 |
|
|