Trial Outcomes & Findings for A Study to Assess the Safety, Tolerability, and Efficacy of ST-400 for Treatment of Transfusion-Dependent Beta-thalassemia (TDT) (NCT NCT03432364)
NCT ID: NCT03432364
Last Updated: 2023-12-14
Results Overview
Safety and tolerability assessed by number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) up to 156 weeks after the ST-400 infusion
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Up to 156 weeks after the ST-400 infusion
Results posted on
2023-12-14
Participant Flow
The original enrollment goal was six subjects were to be enrolled in the Phase 1/2 study ST-400-01, but 5 subjects were enrolled and dosed. One subject from the 5 dosed withdrew consent prior to completing the study. Subjects who received treatment with ST-400 were asked to participate in a separate observational long-term safety study.
Participant milestones
| Measure |
ST-400 Investigational Product
ST-400 Investigational product is composed of autologous CD34+ hematopoietic stem/progenitor cells that are genetically modified ex vivo at the erythroid-specific enhancer of the BCL11A gene
ST-400 Investigational product: Single dose of ST-400 following chemotherapy conditioning with busulfan
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|---|---|
|
Primary (ST-400 Infusion up to Week 52 )
STARTED
|
5
|
|
Primary (ST-400 Infusion up to Week 52 )
COMPLETED
|
5
|
|
Primary (ST-400 Infusion up to Week 52 )
NOT COMPLETED
|
0
|
|
Follow Up (Weeks 52-156 Post Infusion)
STARTED
|
5
|
|
Follow Up (Weeks 52-156 Post Infusion)
COMPLETED
|
4
|
|
Follow Up (Weeks 52-156 Post Infusion)
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
ST-400 Investigational Product
ST-400 Investigational product is composed of autologous CD34+ hematopoietic stem/progenitor cells that are genetically modified ex vivo at the erythroid-specific enhancer of the BCL11A gene
ST-400 Investigational product: Single dose of ST-400 following chemotherapy conditioning with busulfan
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|---|---|
|
Follow Up (Weeks 52-156 Post Infusion)
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Study to Assess the Safety, Tolerability, and Efficacy of ST-400 for Treatment of Transfusion-Dependent Beta-thalassemia (TDT)
Baseline characteristics by cohort
| Measure |
ST-400 Investigational Product
n=5 Participants
ST-400 Investigational product is composed of autologous CD34+ hematopoietic stem/progenitor cells that are genetically modified ex vivo at the erythroid-specific enhancer of the BCL11A gene
ST-400 Investigational product: Single dose of ST-400 following chemotherapy conditioning with busulfan
|
|---|---|
|
Age, Continuous
|
28.4 years
STANDARD_DEVIATION 7.77 • n=5 Participants
|
|
Sex: Female, Male
Sex · Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Sex · Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
|
Hemoglobin A (g/dL) at Baseline
|
11.040 g/dL
STANDARD_DEVIATION 0.6006 • n=5 Participants
|
|
Hemoglobin F (g/dL) at Baseline
|
0.169 g/dL
STANDARD_DEVIATION 0.0835 • n=5 Participants
|
|
Hemoglobin F Percentage at Baseline
|
1.48 Percentage
STANDARD_DEVIATION 0.760 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 156 weeks after the ST-400 infusionPopulation: All subjects who received the ST-400 infusion
Safety and tolerability assessed by number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) up to 156 weeks after the ST-400 infusion
Outcome measures
| Measure |
ST-400 Investigational Product
n=5 Participants
ST-400 Investigational product is composed of autologous CD34+ hematopoietic stem/progenitor cells that are genetically modified ex vivo at the erythroid-specific enhancer of the BCL11A gene. Single dose of ST-400 following chemotherapy conditioning with busulfan.
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|---|---|
|
Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) up to 156 Weeks After the ST-400 Infusion
Incidence of non-serious adverse events
|
5 participants
|
|
Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) up to 156 Weeks After the ST-400 Infusion
Incidence of serious adverse events
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 26, 52, and 156 after ST-400 infusionPopulation: Hb fractions (A and F in g/dL) Change from Baseline to Week 26, Week 52 and Week 156 in Safety Population
Change from baseline clinical laboratory measurement of Hb fractions (A and F in g/dL) \[Time Frame: Up to 156 weeks after ST-400 infusion\]
Outcome measures
| Measure |
ST-400 Investigational Product
n=5 Participants
ST-400 Investigational product is composed of autologous CD34+ hematopoietic stem/progenitor cells that are genetically modified ex vivo at the erythroid-specific enhancer of the BCL11A gene. Single dose of ST-400 following chemotherapy conditioning with busulfan.
|
|---|---|
|
Clinical Laboratory Measurement of Hemoglobin (Hb) Fractions (A and F in g/dL)
Hemoglobin A (g/dL) Change from Baseline to Week 26
|
-3.648 g/dL
Standard Deviation 2.0401
|
|
Clinical Laboratory Measurement of Hemoglobin (Hb) Fractions (A and F in g/dL)
Hemoglobin A (g/dL) Change from Baseline to Week 52
|
-3.227 g/dL
Standard Deviation 2.0789
|
|
Clinical Laboratory Measurement of Hemoglobin (Hb) Fractions (A and F in g/dL)
Hemoglobin A (g/dL) Change from Baseline to Week 156
|
-0.281 g/dL
Standard Deviation 1.5834
|
|
Clinical Laboratory Measurement of Hemoglobin (Hb) Fractions (A and F in g/dL)
Hemoglobin F (g/dL) Change from Baseline to Week 26
|
1.025 g/dL
Standard Deviation 1.0898
|
|
Clinical Laboratory Measurement of Hemoglobin (Hb) Fractions (A and F in g/dL)
Hemoglobin F (g/dL) Change from Baseline to Week 52
|
0.405 g/dL
Standard Deviation 0.2851
|
|
Clinical Laboratory Measurement of Hemoglobin (Hb) Fractions (A and F in g/dL)
Hemoglobin F (g/dL) Change from Baseline to Week 156
|
0.502 g/dL
Standard Deviation 0.2936
|
SECONDARY outcome
Timeframe: Baseline, Weeks 26, 52, and 156 after ST-400 infusionPopulation: Change Percent (%) HbF from Baseline to Week 26, Week 52 and Week 156 in Safety Population
Change from baseline percent (%) HbF \[Time Frame: Up to 156 weeks after ST-400 infusion\]
Outcome measures
| Measure |
ST-400 Investigational Product
n=5 Participants
ST-400 Investigational product is composed of autologous CD34+ hematopoietic stem/progenitor cells that are genetically modified ex vivo at the erythroid-specific enhancer of the BCL11A gene. Single dose of ST-400 following chemotherapy conditioning with busulfan.
|
|---|---|
|
Clinical Laboratory Measurements of Percent (%) HbF
Week 26
|
12.83 Percentage of Hemoglobin F
Standard Deviation 14.282
|
|
Clinical Laboratory Measurements of Percent (%) HbF
Week 52
|
5.30 Percentage of Hemoglobin F
Standard Deviation 3.188
|
|
Clinical Laboratory Measurements of Percent (%) HbF
Week 156
|
4.35 Percentage of Hemoglobin F
Standard Deviation 3.040
|
SECONDARY outcome
Timeframe: From Baseline (2 years prior to screening/consent), to ST-400 Infusion (Day 0), after hematopoietic reconstitution and up to 156 weeks (post ST-400 infusion)Population: Annualized Frequency of Blood Product Transfusion in Safety Population
Calculation of annualized frequency and volume of packed red blood cell (PRBC) transfusions after ST-400 infusion transfusion support in the 2 years prior to screening
Outcome measures
| Measure |
ST-400 Investigational Product
n=5 Participants
ST-400 Investigational product is composed of autologous CD34+ hematopoietic stem/progenitor cells that are genetically modified ex vivo at the erythroid-specific enhancer of the BCL11A gene. Single dose of ST-400 following chemotherapy conditioning with busulfan.
|
|---|---|
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Annualized Frequency of Packed RBC Transfusions
Baseline transfusion support 2 years prior to screening/consent
|
17.393 PRBC transfusions/year
Standard Deviation 5.4350
|
|
Annualized Frequency of Packed RBC Transfusions
At ST-400 Infusion (Day 0)
|
21.518 PRBC transfusions/year
Standard Deviation 4.8806
|
|
Annualized Frequency of Packed RBC Transfusions
After hematopoietic reconstitution (up to 156 weeks after ST-400 infusion)
|
19.665 PRBC transfusions/year
Standard Deviation 5.6716
|
SECONDARY outcome
Timeframe: From Baseline (2 years prior to screening/consent), to ST-400 Infusion (Day 0), after hematopoietic reconstitution and up to 156 weeks (post ST-400 infusion)Population: Blood Product Annualized Total Volume Transfused in Safety Population
Historical baseline defined as transfusion support in the 2 years prior to screening.
Outcome measures
| Measure |
ST-400 Investigational Product
n=5 Participants
ST-400 Investigational product is composed of autologous CD34+ hematopoietic stem/progenitor cells that are genetically modified ex vivo at the erythroid-specific enhancer of the BCL11A gene. Single dose of ST-400 following chemotherapy conditioning with busulfan.
|
|---|---|
|
Annualized Volume (mL) of Packed RBC Transfusions
Baseline transfusion support 2 years prior to screening/consent
|
10295.984 mL/year
Standard Deviation 4063.3661
|
|
Annualized Volume (mL) of Packed RBC Transfusions
At ST-400 infusion (Day 0)
|
7453.191 mL/year
Standard Deviation 4204.3456
|
|
Annualized Volume (mL) of Packed RBC Transfusions
After hematopoietic reconstitution (up to 156 weeks after ST-400 infusion)
|
7068.788 mL/year
Standard Deviation 4480.8901
|
Adverse Events
ST-400 Investigational Product
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ST-400 Investigational Product
n=5 participants at risk
ST-400 Investigational product is composed of autologous CD34+ hematopoietic stem/progenitor cells that are genetically modified ex vivo at the erythroid-specific enhancer of the BCL11A gene. Single dose of ST-400 following chemotherapy conditioning with busulfan.
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|---|---|
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General disorders
Drug withdrawal syndrome
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Immune system disorders
Hypersensitivity
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Infections and infestations
Pneumonia
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
Other adverse events
| Measure |
ST-400 Investigational Product
n=5 participants at risk
ST-400 Investigational product is composed of autologous CD34+ hematopoietic stem/progenitor cells that are genetically modified ex vivo at the erythroid-specific enhancer of the BCL11A gene. Single dose of ST-400 following chemotherapy conditioning with busulfan.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
80.0%
4/5 • Number of events 4 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
80.0%
4/5 • Number of events 8 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
60.0%
3/5 • Number of events 13 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
60.0%
3/5 • Number of events 9 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
20.0%
1/5 • Number of events 8 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Cardiac disorders
Sinus tachycardia
|
40.0%
2/5 • Number of events 2 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Cardiac disorders
Tachycardia
|
40.0%
2/5 • Number of events 4 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Cardiac disorders
Palpitations
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Gastrointestinal disorders
Constipation
|
80.0%
4/5 • Number of events 7 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
80.0%
4/5 • Number of events 8 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
60.0%
3/5 • Number of events 5 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Gastrointestinal disorders
Nausea
|
100.0%
5/5 • Number of events 12 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
1/5 • Number of events 2 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Gastrointestinal disorders
Haemoperitoneum
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Infections and infestations
COVID-19
|
40.0%
2/5 • Number of events 2 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
40.0%
2/5 • Number of events 5 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Infections and infestations
Bacterial sepsis
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Infections and infestations
Coxsackie viral infection
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Infections and infestations
Influenza
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Infections and infestations
Pneumonia
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Infections and infestations
Respiratory syncytial virus infection
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Infections and infestations
Sinusitis
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
40.0%
2/5 • Number of events 5 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
5/5 • Number of events 10 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
40.0%
2/5 • Number of events 3 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Psychiatric disorders
Insomnia
|
100.0%
5/5 • Number of events 6 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Psychiatric disorders
Depression
|
40.0%
2/5 • Number of events 2 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Psychiatric disorders
Anxiety
|
40.0%
2/5 • Number of events 2 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
General disorders
Fatigue
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
General disorders
Non-cardiac chest pain
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
General disorders
Peripheral swelling
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
40.0%
2/5 • Number of events 2 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
40.0%
2/5 • Number of events 3 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Metabolism and nutrition disorders
Iron overload
|
40.0%
2/5 • Number of events 3 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
1/5 • Number of events 2 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
40.0%
2/5 • Number of events 2 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Metabolism and nutrition disorders
Fluid overload
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Nervous system disorders
Headache
|
60.0%
3/5 • Number of events 5 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Nervous system disorders
Hyperaesthesia
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Nervous system disorders
Migraine
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Nervous system disorders
Restless legs syndrome
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Injury, poisoning and procedural complications
Procedural pain
|
60.0%
3/5 • Number of events 5 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
40.0%
2/5 • Number of events 2 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
20.0%
1/5 • Number of events 2 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Investigations
Platelet count decreased
|
40.0%
2/5 • Number of events 10 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Investigations
White blood cell count decreased
|
40.0%
2/5 • Number of events 7 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Investigations
Hepatic enzyme increased
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Investigations
Lymphocyte count decreased
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Investigations
Neutrophil count decreased
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
40.0%
2/5 • Number of events 2 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
40.0%
2/5 • Number of events 2 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bradypnoea
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
20.0%
1/5 • Number of events 3 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
60.0%
3/5 • Number of events 3 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Eye disorders
Dry eye
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Eye disorders
Vision blurred
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Immune system disorders
Hypersensitivity
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Vascular disorders
Hypertension
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Vascular disorders
Hypotension
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Renal and urinary disorders
Dysuria
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Blood and lymphatic system disorders
Leukocytosis
|
40.0%
2/5 • Number of events 2 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Injury, poisoning and procedural complications
Incision site pain
|
20.0%
1/5 • Number of events 2 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Injury, poisoning and procedural complications
Vascular access site pain
|
60.0%
3/5 • Number of events 5 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Investigations
International normalised ratio increased
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
40.0%
2/5 • Number of events 3 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Nervous system disorders
Dysgeusia
|
40.0%
2/5 • Number of events 3 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Renal and urinary disorders
Haematuria
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • Number of events 1 • Participants with adverse events data collected from ICF signed through participant's last study visit, up to 156 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place