Trial Outcomes & Findings for Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sapablursen (Formerly ISIS 702843, IONIS-TMPRSS6-LRx) (NCT NCT04059406)
NCT ID: NCT04059406
Last Updated: 2025-02-18
Results Overview
Blood hemoglobin
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Baseline and Week 27
Results posted on
2025-02-18
Participant Flow
Participants were enrolled in the study at 15 investigative sites in Australia, Greece, Lebanon, Thailand, and Turkey from 24 September 2020 to 28 March 2023.
A total of 71 participants were screened with a diagnosis of β-Thalassemia, of which 29 participants were enrolled in either cohorts A, B, or C to receive sapablursen.
Participant milestones
| Measure |
Cohort A: Sapablursen
Subjects initially received 30 mg/0.3 mL of sapablursen by SC injection once every four weeks up to Week 105. After the protocol Amendment 2 the dose was increased to a maximum of 160 mg.
|
Cohort B: Sapablursen
Subjects initially received 50 mg/0.5 mL of sapablursen by SC injection once every four weeks up to Week 105. After the protocol Amendment 2 the dose was increased to a maximum of 160 mg.
|
Cohort C: Sapablursen
Subjects initially received 80 mg/0.8 mL of sapablursen by SC injection once every four weeks up to Week 105. After the protocol Amendment 2 the dose was increased to a maximum of 160 mg.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
17
|
|
Overall Study
COMPLETED
|
1
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
15
|
Reasons for withdrawal
| Measure |
Cohort A: Sapablursen
Subjects initially received 30 mg/0.3 mL of sapablursen by SC injection once every four weeks up to Week 105. After the protocol Amendment 2 the dose was increased to a maximum of 160 mg.
|
Cohort B: Sapablursen
Subjects initially received 50 mg/0.5 mL of sapablursen by SC injection once every four weeks up to Week 105. After the protocol Amendment 2 the dose was increased to a maximum of 160 mg.
|
Cohort C: Sapablursen
Subjects initially received 80 mg/0.8 mL of sapablursen by SC injection once every four weeks up to Week 105. After the protocol Amendment 2 the dose was increased to a maximum of 160 mg.
|
|---|---|---|---|
|
Overall Study
Early Treatment Termination
|
5
|
5
|
15
|
Baseline Characteristics
Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sapablursen (Formerly ISIS 702843, IONIS-TMPRSS6-LRx)
Baseline characteristics by cohort
| Measure |
Cohort A: Sapablursen
n=6 Participants
Subjects initially received 30 mg/0.3 mL of sapablursen by SC injection once every four weeks up to Week 105. After the protocol Amendment 2 the dose was increased to a maximum of 160 mg.
|
Cohort B: Sapablursen
n=6 Participants
Subjects initially received 50 mg/0.5 mL of sapablursen by SC injection once every four weeks up to Week 105. After the protocol Amendment 2 the dose was increased to a maximum of 160 mg.
|
Cohort C: Sapablursen
n=17 Participants
Subjects initially received 80 mg/0.8 mL of sapablursen by SC injection once every four weeks up to Week 105. After the protocol Amendment 2 the dose was increased to a maximum of 160 mg.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35.0 years
STANDARD_DEVIATION 12.12 • n=99 Participants
|
31.7 years
STANDARD_DEVIATION 10.44 • n=107 Participants
|
32.0 years
STANDARD_DEVIATION 10.88 • n=206 Participants
|
32.6 years
STANDARD_DEVIATION 10.72 • n=7 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 27Population: Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of sapablursen and who had at least 1 Hb assessment collected after Day 1. Here, the "overall number of participants analyzed" signifies the number of participants available for analysis for this outcome measure.
Blood hemoglobin
Outcome measures
| Measure |
Cohort A: Sapablursen
n=6 Participants
Subjects initially received 30 mg/0.3 mL of sapablursen by SC injection once every four weeks up to Week 105. After the protocol Amendment 2 the dose was increased to a maximum of 160 mg.
|
Cohort B: Sapablursen
n=6 Participants
Subjects initially received 50 mg/0.5 mL of sapablursen by SC injection once every four weeks up to Week 105. After the protocol Amendment 2 the dose was increased to a maximum of 160 mg.
|
Cohort C: Sapablursen
n=15 Participants
Subjects initially received 80 mg/0.8 mL of sapablursen by SC injection once every four weeks up to Week 105. After the protocol Amendment 2 the dose was increased to a maximum of 160 mg.
|
|---|---|---|---|
|
Percentage of Participants With a ≥1.0 Grams Per Deciliter (g/dL) Increase From Baseline in Hemoglobin (Hb) at Week 27
|
0 percentage of participants
Interval 0.0 to 45.9
|
0 percentage of participants
Interval 0.0 to 45.9
|
6.7 percentage of participants
Interval 0.2 to 31.9
|
SECONDARY outcome
Timeframe: Week 53Population: FAS included all randomized participants who received at least 1 dose of sapablursen and who had at least 1 Hb assessment collected after Day 1. Here, the "overall number of participants analyzed" signifies the number of participants available for analysis for this outcome measure.
Blood hemoglobin
Outcome measures
| Measure |
Cohort A: Sapablursen
n=6 Participants
Subjects initially received 30 mg/0.3 mL of sapablursen by SC injection once every four weeks up to Week 105. After the protocol Amendment 2 the dose was increased to a maximum of 160 mg.
|
Cohort B: Sapablursen
n=6 Participants
Subjects initially received 50 mg/0.5 mL of sapablursen by SC injection once every four weeks up to Week 105. After the protocol Amendment 2 the dose was increased to a maximum of 160 mg.
|
Cohort C: Sapablursen
n=14 Participants
Subjects initially received 80 mg/0.8 mL of sapablursen by SC injection once every four weeks up to Week 105. After the protocol Amendment 2 the dose was increased to a maximum of 160 mg.
|
|---|---|---|---|
|
Percentage of Participants With a ≥1.5 g/dL Increase From Baseline in Hb at Week 53
|
0 percentage of participants
Interval 0.0 to 45.9
|
0 percentage of participants
Interval 0.0 to 45.9
|
0 percentage of participants
Interval 0.0 to 23.2
|
SECONDARY outcome
Timeframe: Week 53Population: FAS included all randomized participants who received at least 1 dose of sapablursen and who had at least 1 Hb assessment collected after Day 1. Here, the "overall number of participants analyzed" signifies the number of participants available for analysis for this outcome measure.
Liver iron content
Outcome measures
| Measure |
Cohort A: Sapablursen
n=6 Participants
Subjects initially received 30 mg/0.3 mL of sapablursen by SC injection once every four weeks up to Week 105. After the protocol Amendment 2 the dose was increased to a maximum of 160 mg.
|
Cohort B: Sapablursen
n=6 Participants
Subjects initially received 50 mg/0.5 mL of sapablursen by SC injection once every four weeks up to Week 105. After the protocol Amendment 2 the dose was increased to a maximum of 160 mg.
|
Cohort C: Sapablursen
n=14 Participants
Subjects initially received 80 mg/0.8 mL of sapablursen by SC injection once every four weeks up to Week 105. After the protocol Amendment 2 the dose was increased to a maximum of 160 mg.
|
|---|---|---|---|
|
Percentage of Participants With a ≥1.0 Milligrams of Iron Per Grams of Dry Weight of Liver (mg Fe/g) Decrease From Baseline in Liver Iron Concentration (LIC) at Week 53
|
33.3 percentage of participants
Interval 4.3 to 77.7
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
28.6 percentage of participants
Interval 8.4 to 58.1
|
Adverse Events
Cohort A: Sapablursen
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort B: Sapablursen
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort C: Sapablursen
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A: Sapablursen
n=6 participants at risk
Subjects initially received 30 mg/0.3 mL of sapablursen by SC injection once every four weeks up to Week 105. After the protocol Amendment 2 the dose was increased to a maximum of 160 mg once every 4 weeks.
|
Cohort B: Sapablursen
n=6 participants at risk
Subjects initially received 50 mg/0.5 mL of sapablursen by SC injection once every four weeks up to Week 105. After the protocol Amendment 2 the dose was increased to a maximum of 160 mg once every 4 weeks.
|
Cohort C: Sapablursen
n=17 participants at risk
Subjects initially received 80 mg/0.8 mL of sapablursen by SC injection once every four weeks up to Week 105. After the protocol Amendment 2 the dose was increased to a maximum of 160 mg once every 4 weeks.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Forearm Fracture
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
Other adverse events
| Measure |
Cohort A: Sapablursen
n=6 participants at risk
Subjects initially received 30 mg/0.3 mL of sapablursen by SC injection once every four weeks up to Week 105. After the protocol Amendment 2 the dose was increased to a maximum of 160 mg once every 4 weeks.
|
Cohort B: Sapablursen
n=6 participants at risk
Subjects initially received 50 mg/0.5 mL of sapablursen by SC injection once every four weeks up to Week 105. After the protocol Amendment 2 the dose was increased to a maximum of 160 mg once every 4 weeks.
|
Cohort C: Sapablursen
n=17 participants at risk
Subjects initially received 80 mg/0.8 mL of sapablursen by SC injection once every four weeks up to Week 105. After the protocol Amendment 2 the dose was increased to a maximum of 160 mg once every 4 weeks.
|
|---|---|---|---|
|
General disorders
Asthenia
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
General disorders
Injection Site Erythema
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
General disorders
Injection Site Pain
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
General disorders
Injection Site Pruritus
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
General disorders
Malaise
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
General disorders
Peripheral Swelling
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
General disorders
Injection Site Rash
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
33.3%
2/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
General disorders
Vaccination Site Pain
|
33.3%
2/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
General disorders
Pyrexia
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
29.4%
5/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
General disorders
Fatigue
|
66.7%
4/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Reproductive system and breast disorders
Adnexa Uteri Mass
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Reproductive system and breast disorders
Ovulation Pain
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Reproductive system and breast disorders
Heavy Menstrual Bleeding
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
11.8%
2/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Psychiatric disorders
Panic Attack
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Investigations
Blood Urine Present
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Injury, poisoning and procedural complications
Vaccination Complication
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
11.8%
2/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Injury, poisoning and procedural complications
Forearm Fracture
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Congenital, familial and genetic disorders
Odontogenic Cyst
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
33.3%
2/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
11.8%
2/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Nervous system disorders
Sciatica
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Nervous system disorders
Tension Headache
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Nervous system disorders
Tunnel Vision
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Ear and labyrinth disorders
Ear Discomfort
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Eye disorders
Lacrimal Disorder
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
33.3%
2/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
33.3%
2/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Gastrointestinal disorders
Abdominal Pain
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
11.8%
2/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Gastrointestinal disorders
Periodontal Disease
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Hepatobiliary disorders
Jaundice
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Hepatobiliary disorders
Hepatic Mass
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Renal and urinary disorders
Renal Disorder
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Renal and urinary disorders
Microalbuminuria
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Renal and urinary disorders
Hypertonic Bladder
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Renal and urinary disorders
Haematuria
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Renal and urinary disorders
Proteinuria
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Renal and urinary disorders
Dysuria
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Endocrine disorders
Thyroid Mass
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
2/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
17.6%
3/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
33.3%
2/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
11.8%
2/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Infections and infestations
Hordeolum
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Infections and infestations
Bacterial Vaginosis
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Infections and infestations
Tonsillitis
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Infections and infestations
Impetigo
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Infections and infestations
Influenza
|
33.3%
2/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
33.3%
2/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
33.3%
2/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
23.5%
4/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Infections and infestations
COVID-19
|
50.0%
3/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
64.7%
11/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Infections and infestations
Urinary Tract Infection
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
11.8%
2/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
5.9%
1/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Infections and infestations
Infected Skin Ulcer
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
|
Infections and infestations
Staphylococcal Infection
|
0.00%
0/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
16.7%
1/6 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
0.00%
0/17 • From signing of informed consent to early termination (up to 733 days)
Safety set included all randomized participants who received at least 1 dose of sapablursen.
|
Additional Information
Ionis Pharmaceuticals, Inc.
Ionis Pharmaceuticals, Inc.
Phone: 760-603-2346
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place