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This study evaluated the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of multiple intravenous (IV) doses of ALXN1210 administered to participants with PNH who have not previously been treated with complement inhibitor.
The data presented is up to the Primary Completion date of the study and is for the 24-week Primary Evaluation period. The study also includes an Extension Period of up to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants were administered ALXN1210 900 mg. In the Extension period participants continued at the same dose and frequency as the Primary Evaluation Period. |
|
| Cohort 2 | Experimental | Participants were administered ALXN1210 1800 mg. In the Extension period participants continued at the same dose and frequency as the Primary Evaluation Period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALXN1210 | Biological | Participants were administered ravulizumab as an IV infusion every 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change In Lactate Dehydrogenase (LDH) Levels From Baseline To Day 169 | Baseline was defined as the average of all available assessments prior to first ALXN1210 infusion. | Baseline, Day 169 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change In Free Hemoglobin Levels From Baseline To Day 169 And Day 1821 | Baseline was defined as the last non-missing assessment value prior to the first ALXN1210 infusion. | Baseline, Day 169, Day 1821 |
| Percent Change In Haptoglobin Levels From Baseline To Day 169 And Day 1821 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexion Pharmaceuticals, Inc. | Alexion Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Liverpool | New South Wales | 2170 | Australia | ||
| Clinical Trial Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30171081 | Background | Roth A, Rottinghaus ST, Hill A, Bachman ES, Kim JS, Schrezenmeier H, Terriou L, Urbano-Ispizua A, Wells RA, Jang JH, Kulasekararaj AG, Szer J, Aguzzi R, Damokosh AI, Shafner L, Lee JW. Ravulizumab (ALXN1210) in patients with paroxysmal nocturnal hemoglobinuria: results of 2 phase 1b/2 studies. Blood Adv. 2018 Sep 11;2(17):2176-2185. doi: 10.1182/bloodadvances.2018020644. |
| Label | URL |
|---|---|
| Ravulizumab (ALXN1210) in patients with paroxysmal nocturnal hemoglobinuria: results of 2 phase 1b/2 studies | View source |
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Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
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| ID | Title | Description |
|---|---|---|
| FG000 | ALXN1210 Cohort 1 | Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter |
| FG001 | ALXN1210 Cohort 2 | Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary Evaluation Period |
| |||||||||||||
| Extension Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ALXN1210 Cohort 1 | Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter |
| BG001 | ALXN1210 Cohort 2 |
| 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 | Percent Change In Lactate Dehydrogenase (LDH) Levels From Baseline To Day 169 | Baseline was defined as the average of all available assessments prior to first ALXN1210 infusion. | The full analysis set included all enrolled participants who received at least 1 dose of ALXN1210 and who had a Baseline measurement with at least 1 LDH measurement post-first ALXN1210 dose. Data were summarized only for participants with assessment at Baseline and the specified time point. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 169 |
|
Day 1 through Day 1957
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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 | ALXN1210 Cohort 1 | Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Meningococcal infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexion Pharmaceuticals, Inc. | Alexion Pharmaceuticals, Inc. | +1 855-752-2356 | clinicaltrials@alexion.com |
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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 |
|---|---|
| C000629409 | ravulizumab |
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Baseline was defined as the last non-missing assessment value prior to the first ALXN1210 infusion. |
| Baseline, Day 169, Day 1821 |
| Percent Change In Reticulocyte/Erythrocyte Count From Baseline To Day 169 And Day 1821 | Baseline was defined as the last non-missing assessment value prior to the first ALXN1210 infusion. | Baseline, Day 169, Day 1821 |
| Percent Change In Paroxysmal Nocturnal Hemoglobinuria (PNH) Red Blood Cell (RBC) Clones From Baseline To Day 169 And Day 1933 | Baseline was defined as the last non-missing assessment value prior to the first ALXN1210 infusion. | Baseline, Day 169, Day 1933 |
| Percent Change In D-dimer Levels From Baseline To Day 169 And Day 1821 | Baseline was defined as the last non-missing assessment value prior to the first ALXN1210 infusion. | Baseline, Day 169, Day 1821 |
| Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821 | Clinical manifestations are defined as fatigue, abdominal pain, dyspnea, dysphagia, chest pain, and erectile dysfunction (ED) by cohort. Improvement is defined as present at baseline and absent at Day 169 endpoint. Worsening is defined as absent at Baseline and present at Day 169 endpoint. | Baseline, Day 169, Day 1821 |
| Area Under The Serum Concentration-versus-time-curve From Time 0 (Dosing) To The Last Quantifiable Concentration (AUCt) At Day 1 | AUCt reported in hours*microgram/milliliter (h*ug/mL). | Day 1 |
| AUCt/ Dose-normalized (D) At Day 1 | Day 1 |
| Area Under The Serum Concentration-versus-time-curve From Time 0 (Dosing) To The End Of The Dosing Interval (AUCtau) At Day 141 | Day 141 |
| AUCtau/D At Day 141 | Day 141 |
| Maximum Observed Serum Concentration (Cmax) At Day 1 And Day 141 | Day 1 and Day 141 |
| Cmax/D At Day 1 And Day 141 | Day 1 and Day 141 |
| Concentration At The End Of The Dosage Interval (Ctrough) At Day 1 And At Day 141 | Day 1 and Day 141 |
| Time To Maximum Observed Serum Concentration (Tmax) At Day 1 And Day 141 | Day 1 and Day 141 |
| Percent Change In Chicken Red Blood Cell (cRBC) Hemolysis From Baseline To Day 1709 | Baseline, Day 1709 |
| Percent Change In Free Complement Component 5 (C5) Concentration From Baseline To Day 1709 | Baseline, Day 1709 |
| Percent Change In Total C5 Concentration From Baseline To Day 1709 | Baseline, Day 1709 |
| Participants Experiencing Antidrug Antibodies (ADAs) | Day 1821 |
| Woolloongabba |
| Queensland |
| 4102 |
| Australia |
| Clinical Trial Site | Seoul | 03080 | South Korea |
| Clinical Trial Site | Seoul | 03722 | South Korea |
| Clinical Trial Site | Seoul | 05505 | South Korea |
| Clinical Trial Site | Seoul | 06351 | South Korea |
| Clinical Trial Site | Seoul | 06951 | South Korea |
| Clinical Trial Site | Ulsan | 44033 | South Korea |
| NOT COMPLETED |
|
|
Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| ALXN1210 Cohort 2 |
Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter |
|
|
| Secondary | Percent Change In Free Hemoglobin Levels From Baseline To Day 169 And Day 1821 | Baseline was defined as the last non-missing assessment value prior to the first ALXN1210 infusion. | The full analysis set included all enrolled participants who received at least 1 dose of ALXN1210 and who had a Baseline measurement with at least 1 free hemoglobin measurement post-first ALXN1210 dose. Data were summarized only for participants with assessment at Baseline and the specified time point. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 169, Day 1821 |
|
|
|
| Secondary | Percent Change In Haptoglobin Levels From Baseline To Day 169 And Day 1821 | Baseline was defined as the last non-missing assessment value prior to the first ALXN1210 infusion. | The full analysis set included all enrolled participants who received at least 1 dose of ALXN1210 and who had a Baseline measurement with at least 1 haptoglobin measurement post-first ALXN1210 dose. Data were summarized only for participants with assessment at Baseline and the specified time point. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 169, Day 1821 |
|
|
|
| Secondary | Percent Change In Reticulocyte/Erythrocyte Count From Baseline To Day 169 And Day 1821 | Baseline was defined as the last non-missing assessment value prior to the first ALXN1210 infusion. | The full analysis set included all enrolled participants who received at least 1 dose of ALXN1210 and who had a Baseline measurement with at least 1 reticulocyte/erythrocyte count measurement post-first ALXN1210 dose. Data were summarized only for participants with assessment at Baseline and the specified time point. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 169, Day 1821 |
|
|
|
| Secondary | Percent Change In Paroxysmal Nocturnal Hemoglobinuria (PNH) Red Blood Cell (RBC) Clones From Baseline To Day 169 And Day 1933 | Baseline was defined as the last non-missing assessment value prior to the first ALXN1210 infusion. | The full analysis set included all enrolled participants who received at least 1 dose of ALXN1210 and who had a Baseline measurement with at least 1 PNH RBC clones measurement post-first ALXN1210 dose. Data were summarized only for participants with assessment at Baseline and the specified time point. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 169, Day 1933 |
|
|
|
| Secondary | Percent Change In D-dimer Levels From Baseline To Day 169 And Day 1821 | Baseline was defined as the last non-missing assessment value prior to the first ALXN1210 infusion. | The full analysis set included all enrolled participants who received at least 1 dose of ALXN1210 and who had a Baseline measurement with at least 1 D-dimer measurement post-first ALXN1210 dose. Data were summarized only for participants with assessment at Baseline and the specified time point. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 169, Day 1821 |
|
|
|
| Secondary | Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821 | Clinical manifestations are defined as fatigue, abdominal pain, dyspnea, dysphagia, chest pain, and erectile dysfunction (ED) by cohort. Improvement is defined as present at baseline and absent at Day 169 endpoint. Worsening is defined as absent at Baseline and present at Day 169 endpoint. | The full analysis set included all enrolled participants who received at least 1 dose of ALXN1210 and who had a Baseline measurement with at least 1 clinical manifestation of PNH assessed post-first ALXN1210 dose. Data were summarized only for participants with assessment at Baseline and the specified time point. ED affects only male participants. | Posted | Count of Participants | Participants | Baseline, Day 169, Day 1821 |
|
|
|
| Secondary | Area Under The Serum Concentration-versus-time-curve From Time 0 (Dosing) To The Last Quantifiable Concentration (AUCt) At Day 1 | AUCt reported in hours*microgram/milliliter (h*ug/mL). | Pharmacokinetics (PK) Analysis Set: all participants who had sufficient serum concentration data to enable the calculation of PK parameters. | Posted | Mean | Standard Deviation | h*ug/mL | Day 1 |
|
|
|
| Secondary | AUCt/ Dose-normalized (D) At Day 1 | PK Analysis Set: all participants who had sufficient serum concentration data to enable the calculation of PK parameters. | Posted | Mean | Standard Deviation | h*ug/mL/mg | Day 1 |
|
|
|
| Secondary | Area Under The Serum Concentration-versus-time-curve From Time 0 (Dosing) To The End Of The Dosing Interval (AUCtau) At Day 141 | PK Analysis Set: all participants who had sufficient serum concentration data to enable the calculation of PK parameters. | Posted | Mean | Standard Deviation | h*ug/mL | Day 141 |
|
|
|
| Secondary | AUCtau/D At Day 141 | PK Analysis Set: all participants who had sufficient serum concentration data to enable the calculation of PK parameters | Posted | Mean | Standard Deviation | h*ug/mL/mg | Day 141 |
|
|
|
| Secondary | Maximum Observed Serum Concentration (Cmax) At Day 1 And Day 141 | PK Analysis Set: all participants who had sufficient serum concentration data to enable the calculation of PK parameters. | Posted | Mean | Standard Deviation | ug/mL | Day 1 and Day 141 |
|
|
|
| Secondary | Cmax/D At Day 1 And Day 141 | PK Analysis Set: all participants who had sufficient serum concentration data to enable the calculation of PK parameters. | Posted | Mean | Standard Deviation | ug/mL/mg | Day 1 and Day 141 |
|
|
|
| Secondary | Concentration At The End Of The Dosage Interval (Ctrough) At Day 1 And At Day 141 | PK Analysis Set: all participants who had sufficient serum concentration data to enable the calculation of PK parameters. | Posted | Mean | Standard Deviation | ug/mL | Day 1 and Day 141 |
|
|
|
| Secondary | Time To Maximum Observed Serum Concentration (Tmax) At Day 1 And Day 141 | PK Analysis Set: all participants who had sufficient serum concentration data to enable the calculation of PK parameters. | Posted | Mean | Standard Deviation | h | Day 1 and Day 141 |
|
|
|
| Secondary | Percent Change In Chicken Red Blood Cell (cRBC) Hemolysis From Baseline To Day 1709 | Pharmacodynamics (PD) Analysis Set: all participants who had a measurement both before and after the first dose of ravulizumab. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 1709 |
|
|
|
| Secondary | Percent Change In Free Complement Component 5 (C5) Concentration From Baseline To Day 1709 | PD Analysis Set: all participants who had a measurement both before and after the first dose of ravulizumab. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 1709 |
|
|
|
| Secondary | Percent Change In Total C5 Concentration From Baseline To Day 1709 | PD Analysis Set: all participants who had a measurement both before and after the first dose of ravulizumab. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 1709 |
|
|
|
| Secondary | Participants Experiencing Antidrug Antibodies (ADAs) | Immunogenicity Analysis Set: all participants who had an ADA sample both before and after the first dose of ravulizumab. | Posted | Count of Participants | Participants | Day 1821 |
|
|
|
| Post-Hoc | Percent Change In LDH Levels From Baseline To Day 1821 | Baseline was defined as the average of all available assessments prior to first ALXN1210 infusion. | The full analysis set included all enrolled participants who received at least 1 dose of ALXN1210 and who had a Baseline measurement with at least 1 LDH measurement post-first ALXN1210 dose. Data were summarized only for participants with assessment at Baseline and the specified time point. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 1821 |
|
|
|
| 0 |
| 6 |
| 3 |
| 6 |
| 6 |
| 6 |
| EG001 | ALXN1210 Cohort 2 | Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter | 0 | 7 | 4 | 7 | 7 | 7 |
| Parvovirus infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Tubo-ovarian abscess | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA (24.0) | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA (24.0) | Systematic Assessment |
|
| Cholangitis acute | Hepatobiliary disorders | MedDRA (24.0) | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (24.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Reflux laryngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA (24.0) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (24.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Parvovirus infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Chlamydial infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Enterocolitis viral | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Laryngopharyngitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Nipple infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Oophoritis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Puncture site pain | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Tooth loss | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Rhinitis atrophic | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
|
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA (24.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Face injury | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
|
| Middle ear effusion | Ear and labyrinth disorders | MedDRA (24.0) | Systematic Assessment |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA (24.0) | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA (24.0) | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (24.0) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
|
| Paroxysmal nocturnal haemoglobinuria | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
|
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (24.0) | Systematic Assessment |
|
Not provided
Not provided
| D009190 |
| Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |
| Day 1821 |
|
|
| Day 1821 |
|
|
| Day 1821 |
|
|
| Day 1933 |
|
|
| Day 1821 |
|
|
| Worsened from Baseline |
|
| No Change/Not Applicable |
|
| Fatigue: Day 1821 |
|
|
| Abdominal pain: Day 169 |
|
|
| Abdominal pain: Day 1821 |
|
|
| Dyspnoea: Day 169 |
|
|
| Dyspnoea: Day 1821 |
|
|
| Dysphagia: Day 169 |
|
|
| Dysphagia: Day 1821 |
|
|
| Chest pain: Day 169 |
|
|
| Chest pain: Day 1821 |
|
|
| ED: Day 169 |
|
|
| ED: Day 1821 |
|
|