Trial Outcomes & Findings for Study Exploring the Effect of Crizanlizumab on Kidney Function in Patients With Chronic Kidney Disease Caused by Sickle Cell Disease (NCT NCT04053764)
NCT ID: NCT04053764
Last Updated: 2024-10-09
Results Overview
The effect of SEG101 on clinical disease activity was measured by at least 30% decrease in Albumin to Creatinine Ratio (ACR) from baseline to month 12. A reduction from baseline indicates improvement in patients.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
Baseline to 12 months
Results posted on
2024-10-09
Participant Flow
Patients were enrolled in 24 centers in 11 countries.
Patients were stratified at randomization based on CKD risk category (moderate risk or high/very high risk) and HU/HC use (Yes/No). At visit "Week 1 Day 1" all eligible patients were randomized via Interactive Response Technology (IRT) to one of the treatment arms.
Participant milestones
| Measure |
Crizanlizumab + Standard of Care
5 mg/kg by intravenous (i.v.) infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51 in addition to their usual standard of care treatment.
|
Standard of Care (SOC)
Patients in the standard of care alone arm will continue to receive their usual standard of care treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
28
|
|
Overall Study
Entered Post-treatment Follow-up, Discontinued
|
7
|
1
|
|
Overall Study
Did Not Enter Post-treatment Follow-up
|
3
|
2
|
|
Overall Study
Not Treated
|
1
|
0
|
|
Overall Study
COMPLETED
|
20
|
25
|
|
Overall Study
NOT COMPLETED
|
10
|
3
|
Reasons for withdrawal
| Measure |
Crizanlizumab + Standard of Care
5 mg/kg by intravenous (i.v.) infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51 in addition to their usual standard of care treatment.
|
Standard of Care (SOC)
Patients in the standard of care alone arm will continue to receive their usual standard of care treatment.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
2
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Pregnancy
|
1
|
0
|
Baseline Characteristics
The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
Baseline characteristics by cohort
| Measure |
Crizanlizumab + Standard of Care
n=30 Participants
5 mg/kg by intravenous (i.v.) infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51 in addition to their usual standard of care treatment.
|
Standard of Care (SOC)
n=28 Participants
Patients in the standard of care alone arm will continue to receive their usual standard of care treatment.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.8 Years
STANDARD_DEVIATION 9.52 • n=99 Participants
|
41.1 Years
STANDARD_DEVIATION 8.71 • n=107 Participants
|
41.5 Years
STANDARD_DEVIATION 9.06 • n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
15 Participants
n=99 Participants • The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
|
15 Participants
n=107 Participants • The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
|
30 Participants
n=206 Participants • The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=99 Participants • The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
|
12 Participants
n=107 Participants • The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
|
27 Participants
n=206 Participants • The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=99 Participants • The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
|
1 Participants
n=107 Participants • The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
|
1 Participants
n=206 Participants • The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsPopulation: The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
The effect of SEG101 on clinical disease activity was measured by at least 30% decrease in Albumin to Creatinine Ratio (ACR) from baseline to month 12. A reduction from baseline indicates improvement in patients.
Outcome measures
| Measure |
Crizanlizumab + Standard of Care
n=30 Participants
5 mg/kg by intravenous (i.v.) infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51 in addition to their usual standard of care treatment.
|
Standard of Care (SOC)
n=28 Participants
Patients in the standard of care alone arm will continue to receive their usual standard of care treatment.
|
All Patients
All the participants enrolled in the trial.
|
|---|---|---|---|
|
Percentage of Participants With ≥ 30% Decrease in Albuminuria (ACR) at 12 Months
|
33.3 Percentage of participants
|
21.4 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 3, 6, 9, and 12 monthsPopulation: Participants in the FAS with an available assessment for the outcome measure at baseline and at each timepoint. The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
The effect of SEG101 on clinical disease activity was measured by the change in albuminuria (ACR) between baseline and month 3, baseline and month 6, baseline and month 9, baseline and month 12. A reduction from baseline indicates improvement in patients.
Outcome measures
| Measure |
Crizanlizumab + Standard of Care
n=29 Participants
5 mg/kg by intravenous (i.v.) infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51 in addition to their usual standard of care treatment.
|
Standard of Care (SOC)
n=28 Participants
Patients in the standard of care alone arm will continue to receive their usual standard of care treatment.
|
All Patients
All the participants enrolled in the trial.
|
|---|---|---|---|
|
Change From Baseline in Albuminuria (ACR) at 3, 6, 9 and 12 Months
Baseline (BL)
|
597.0 mg/g
Standard Deviation 534.3
|
499.0 mg/g
Standard Deviation 486.7
|
—
|
|
Change From Baseline in Albuminuria (ACR) at 3, 6, 9 and 12 Months
Month 3 change from BL
|
-56.9 mg/g
Standard Deviation 362.8
|
159.0 mg/g
Standard Deviation 809.9
|
—
|
|
Change From Baseline in Albuminuria (ACR) at 3, 6, 9 and 12 Months
Month 6 change from BL
|
-98.5 mg/g
Standard Deviation 382.2
|
-35.4 mg/g
Standard Deviation 384.4
|
—
|
|
Change From Baseline in Albuminuria (ACR) at 3, 6, 9 and 12 Months
Month 9 change from BL
|
-12.3 mg/g
Standard Deviation 586.6
|
95.2 mg/g
Standard Deviation 376.2
|
—
|
|
Change From Baseline in Albuminuria (ACR) at 3, 6, 9 and 12 Months
Month 12 change from BL
|
17.7 mg/g
Standard Deviation 620.7
|
14.7 mg/g
Standard Deviation 307.1
|
—
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
The effect of SEG101 on clinical disease activity was measured by at least 30% decrease in Albumin to Creatinine Ratio (ACR) from baseline to month 6. A reduction from baseline indicates improvement in patients.
Outcome measures
| Measure |
Crizanlizumab + Standard of Care
n=30 Participants
5 mg/kg by intravenous (i.v.) infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51 in addition to their usual standard of care treatment.
|
Standard of Care (SOC)
n=28 Participants
Patients in the standard of care alone arm will continue to receive their usual standard of care treatment.
|
All Patients
All the participants enrolled in the trial.
|
|---|---|---|---|
|
Percentage of Participants With ≥ 30% Decrease in Albuminuria (ACR) at 6 Months
|
30.0 Percentage of participants
|
35.7 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
The effect of SEG101 on clinical disease activity was measured by counting patients who had Stable PCR: within ± 20% change from baseline to month 12. PCR improvement: ≥ 20% decrease in PCR from baseline indicates improvement in patients.
Outcome measures
| Measure |
Crizanlizumab + Standard of Care
n=30 Participants
5 mg/kg by intravenous (i.v.) infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51 in addition to their usual standard of care treatment.
|
Standard of Care (SOC)
n=28 Participants
Patients in the standard of care alone arm will continue to receive their usual standard of care treatment.
|
All Patients
All the participants enrolled in the trial.
|
|---|---|---|---|
|
Percentage of Participants With Protein/Creatinine Ratio (PCR) Improvement and Stable PCR at 12 Months
Percentage of participants with PCR improvement at 12 months
|
33.3 Percentage of participants
|
35.7 Percentage of participants
|
—
|
|
Percentage of Participants With Protein/Creatinine Ratio (PCR) Improvement and Stable PCR at 12 Months
Percentage of participants with stable PCR at 12 months
|
16.7 Percentage of participants
|
25.0 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 3, 6, 9, and 12 monthsPopulation: Participants in the FAS with an available assessment for the outcome measure at baseline and at each timepoint. The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
The percentage change in eGFR was calculated as the post-baseline eGFR value minus the baseline eGFR divided by the eGFR at baseline. A reduction from baseline indicates improvement in participants.
Outcome measures
| Measure |
Crizanlizumab + Standard of Care
n=28 Participants
5 mg/kg by intravenous (i.v.) infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51 in addition to their usual standard of care treatment.
|
Standard of Care (SOC)
n=28 Participants
Patients in the standard of care alone arm will continue to receive their usual standard of care treatment.
|
All Patients
All the participants enrolled in the trial.
|
|---|---|---|---|
|
Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Month 3 change from BL
|
-2.5 Percentage change in eGFR
Standard Deviation 8.9
|
-0.5 Percentage change in eGFR
Standard Deviation 10.0
|
—
|
|
Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Month 6 change from BL
|
-2.7 Percentage change in eGFR
Standard Deviation 5.5
|
-7.3 Percentage change in eGFR
Standard Deviation 12.7
|
—
|
|
Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Month 9 change from BL
|
-0.2 Percentage change in eGFR
Standard Deviation 12.8
|
-2.7 Percentage change in eGFR
Standard Deviation 8.7
|
—
|
|
Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Month 12 change from BL
|
-4.9 Percentage change in eGFR
Standard Deviation 14.1
|
-6.3 Percentage change in eGFR
Standard Deviation 13.2
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Participants in the FAS with an available assessment for the outcome measure at baseline and up to 12 months. The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
The effect of SEG101 on clinical disease activity was measured by the slope of ACR decline between baseline and Month 12. A reduction from baseline indicates improvement in patients.
Outcome measures
| Measure |
Crizanlizumab + Standard of Care
n=29 Participants
5 mg/kg by intravenous (i.v.) infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51 in addition to their usual standard of care treatment.
|
Standard of Care (SOC)
n=28 Participants
Patients in the standard of care alone arm will continue to receive their usual standard of care treatment.
|
All Patients
All the participants enrolled in the trial.
|
|---|---|---|---|
|
Slope of Albumin to Creatinine Ratio (ACR) Decline
|
1.70 mg/g per month
Standard Error 8.655
|
4.49 mg/g per month
Standard Error 8.159
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Participants in the FAS with an available assessment for the outcome measure at baseline and up to 12 months. The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
The effect of SEG101 on clinical disease activity was measured by the slope of eGFR between baseline and Month 12. The calculation of eGFR is based on the chronic kidney disease epidemiology collaboration (CKD-EPI) (for patients ≥ 18) and Creatinine-based "Bedside Schwartz" (for patients \< 18) equations. A reduction in drop rate from baseline indicates improvement in patients.
Outcome measures
| Measure |
Crizanlizumab + Standard of Care
n=28 Participants
5 mg/kg by intravenous (i.v.) infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51 in addition to their usual standard of care treatment.
|
Standard of Care (SOC)
n=28 Participants
Patients in the standard of care alone arm will continue to receive their usual standard of care treatment.
|
All Patients
All the participants enrolled in the trial.
|
|---|---|---|---|
|
Slope of Estimated Glomerular Filtration Rate (eGFR) Decline
|
-0.1 mL/min/1.73 m^2 per month
Standard Error 0.18
|
-0.4 mL/min/1.73 m^2 per month
Standard Error 0.16
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
The effect of SEG101 on clinical disease activity was measured by percentage of participants with CKD progression between baseline and Month 12. A reduction from baseline indicates improvement in participants. CKD progression is defined as an increase in CKD progression category, a 25% or greater drop in eGFR from baseline or at least 50% increase in ACR for patients with severe (A3) albuminuria and a doubling of albumin levels in patients with moderate (A2) albuminuria.
Outcome measures
| Measure |
Crizanlizumab + Standard of Care
n=30 Participants
5 mg/kg by intravenous (i.v.) infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51 in addition to their usual standard of care treatment.
|
Standard of Care (SOC)
n=28 Participants
Patients in the standard of care alone arm will continue to receive their usual standard of care treatment.
|
All Patients
All the participants enrolled in the trial.
|
|---|---|---|---|
|
Percentage of Participants With Progression of Chronic Kidney Disease (CKD) at 12 Months
|
13.3 Percentage of participants
|
32.1 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and month 12Population: The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
The effect of SEG101 on clinical disease activity was measured by percentage of participants with CKD progression between baseline and Month 12. A reduction from baseline indicates improvement in patients.
Outcome measures
| Measure |
Crizanlizumab + Standard of Care
n=30 Participants
5 mg/kg by intravenous (i.v.) infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51 in addition to their usual standard of care treatment.
|
Standard of Care (SOC)
n=28 Participants
Patients in the standard of care alone arm will continue to receive their usual standard of care treatment.
|
All Patients
n=58 Participants
All the participants enrolled in the trial.
|
|---|---|---|---|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat Missing baseline to Cat 4 at Worst post-baseline
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat 0 at baseline
|
3.3 Percentage of participants
|
14.3 Percentage of participants
|
8.6 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat 0 at baseline to Cat 2 at Worst post-baseline
|
100.0 Percentage of participants
|
75.0 Percentage of participants
|
80.0 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat 0 at baseline to Cat 3 at Worst post-baseline
|
0 Percentage of participants
|
25.0 Percentage of participants
|
20.0 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat 0 at baseline to Cat 4 at Worst post-baseline
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat 0 at baseline to Missing at Worst post-baseline
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat 1 at baseline
|
36.7 Percentage of participants
|
53.6 Percentage of participants
|
44.8 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat 1 at baseline to Cat 2 at Worst post-baseline
|
36.4 Percentage of participants
|
40.0 Percentage of participants
|
38.5 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat 1 at baseline to Cat 3 at Worst post-baseline
|
45.5 Percentage of participants
|
53.3 Percentage of participants
|
50.0 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat 1 at baseline to Cat 4 at Worst post-baseline
|
0 Percentage of participants
|
6.7 Percentage of participants
|
3.8 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat 1 at baseline to Missing at Worst post-baseline
|
18.2 Percentage of participants
|
0 Percentage of participants
|
7.7 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat 2 at baseline
|
43.3 Percentage of participants
|
28.6 Percentage of participants
|
36.2 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat 2 at baseline to Cat 2 at Worst post-baseline
|
15.4 Percentage of participants
|
12.5 Percentage of participants
|
14.3 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat 2 at baseline to Cat 3 at Worst post-baseline
|
69.2 Percentage of participants
|
75.5 Percentage of participants
|
71.4 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat 2 at baseline to Cat 4 at Worst post-baseline
|
7.7 Percentage of participants
|
12.5 Percentage of participants
|
9.5 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat 2 at baseline to Missing at Worst post-baseline
|
7.7 Percentage of participants
|
0 Percentage of participants
|
4.8 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat 3 at baseline
|
6.7 Percentage of participants
|
3.6 Percentage of participants
|
5.2 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat 3 at baseline to Cat 2 at Worst post-baseline
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat 3 at baseline to Cat 3 at Worst post-baseline
|
50.0 Percentage of participants
|
0 Percentage of participants
|
33.3 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat 3 at baseline to Cat 4 at Worst post-baseline
|
50.0 Percentage of participants
|
100.0 Percentage of participants
|
66.7 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat 3 at baseline to Missing at Worst post-baseline
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat 4 at baseline
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat 4 at baseline to Cat 2 at Worst post-baseline
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat 4 at baseline to Cat 3 at Worst post-baseline
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat 4 at baseline to Cat 4 at Worst post-baseline
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat 4 at baseline to Missing at Worst post-baseline
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat Missing at baseline
|
10.0 Percentage of participants
|
0 Percentage of participants
|
5.2 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat Missing baseline to Cat 2 at Worst post-baseline
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat Missing baseline to Cat 3 at Worst post-baseline
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Shift Table for Chronic Kidney Disease (CKD) Progression
Cat Missing baseline to Missing at Worst post-baseline
|
100.0 Percentage of participants
|
0 Percentage of participants
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to follow-up period (at select time points), assessed up to approximately 1 year and 4 monthsPopulation: Participants in the FAS with an available assessment for the outcome measure at baseline and up to 12 months. The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
The effect of SEG101 on clinical disease activity was measured by percentage of participants shifted to different worst post-baseline categories between baseline and Month 12. An increase in percentage shifting from higher category to lower category indicates improvement in patients. Baseline is defined as the last non-missing value prior to the first dose.
Outcome measures
| Measure |
Crizanlizumab + Standard of Care
n=29 Participants
5 mg/kg by intravenous (i.v.) infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51 in addition to their usual standard of care treatment.
|
Standard of Care (SOC)
Patients in the standard of care alone arm will continue to receive their usual standard of care treatment.
|
All Patients
All the participants enrolled in the trial.
|
|---|---|---|---|
|
Immunogenicity: Percentage of Participants With Anti-drug Antibodies (ADA) to Crizanlizumab
Negative at baseline to Only last sample positive
|
0 Percentage of participants
|
—
|
—
|
|
Immunogenicity: Percentage of Participants With Anti-drug Antibodies (ADA) to Crizanlizumab
Negative at baseline to Any positive
|
3.4 Percentage of participants
|
—
|
—
|
|
Immunogenicity: Percentage of Participants With Anti-drug Antibodies (ADA) to Crizanlizumab
Negative at baseline to All positive
|
0 Percentage of participants
|
—
|
—
|
|
Immunogenicity: Percentage of Participants With Anti-drug Antibodies (ADA) to Crizanlizumab
Negative at baseline to All Negative
|
89.7 Percentage of participants
|
—
|
—
|
|
Immunogenicity: Percentage of Participants With Anti-drug Antibodies (ADA) to Crizanlizumab
Negative at baseline to All Missing
|
6.9 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to follow-up period (at select time points), assessed up to approximately 1 year and 4 monthsPopulation: The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
The effect of SEG101 on clinical disease activity was measured by summarizing the annualized rate of visits to ER and hospitalizations between baseline and 1 year 4 months. Annualized rate of hospitalizations and ER visits due to VOC =(Number of ER or hospitalizations reported until End date x 365.25)/(End date-date of first dose of study treatment+1). A reduction from baseline indicates improvement in patients.
Outcome measures
| Measure |
Crizanlizumab + Standard of Care
n=30 Participants
5 mg/kg by intravenous (i.v.) infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51 in addition to their usual standard of care treatment.
|
Standard of Care (SOC)
n=28 Participants
Patients in the standard of care alone arm will continue to receive their usual standard of care treatment.
|
All Patients
All the participants enrolled in the trial.
|
|---|---|---|---|
|
Annualized Rate of Visits to Emergency Room (ER) and Hospitalizations
|
0.6 ER or hospitalizations/year
Standard Deviation 2.1
|
1.1 ER or hospitalizations/year
Standard Deviation 3.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 336 hours post-dose on Week 3 Day 1; pre-dose and 672 hours post dose on Week 11 Day 1, Week 23 Day 1 and Week 39 Day 1; and 672 hours post dose on Week 53 Day 1Population: Participants in the FAS with an available assessment for the outcome measure at baseline and up to 12 months. The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
The effect of SEG101 on clinical disease activity was measured by checking the concentration of the Drug in serum at different time points. Crizanlizumab pre-dose/trough pharmacokinetic samples were taken at select time points.
Outcome measures
| Measure |
Crizanlizumab + Standard of Care
n=29 Participants
5 mg/kg by intravenous (i.v.) infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51 in addition to their usual standard of care treatment.
|
Standard of Care (SOC)
Patients in the standard of care alone arm will continue to receive their usual standard of care treatment.
|
All Patients
All the participants enrolled in the trial.
|
|---|---|---|---|
|
Mean Serum Concentration (Ctrough) of Crizanlizumab
Week 3 Day1: 0 hours pre-dose
|
11.6 μg/mL
Standard Deviation 2.66
|
—
|
—
|
|
Mean Serum Concentration (Ctrough) of Crizanlizumab
Week 3 Day1: 336 hours post-dose
|
12.1 μg/mL
Standard Deviation 2.38
|
—
|
—
|
|
Mean Serum Concentration (Ctrough) of Crizanlizumab
Week 11 Day1: 0 hours pre-dose
|
4.78 μg/mL
Standard Deviation 3.49
|
—
|
—
|
|
Mean Serum Concentration (Ctrough) of Crizanlizumab
Week 11 Day1: 672 hours post-dose
|
5.67 μg/mL
Standard Deviation 3.11
|
—
|
—
|
|
Mean Serum Concentration (Ctrough) of Crizanlizumab
Week 23 Day1: 0 hours pre-dose
|
4.77 μg/mL
Standard Deviation 2.82
|
—
|
—
|
|
Mean Serum Concentration (Ctrough) of Crizanlizumab
Week 23 Day1: 672 hours post-dose
|
5.54 μg/mL
Standard Deviation 2.21
|
—
|
—
|
|
Mean Serum Concentration (Ctrough) of Crizanlizumab
Week 39 Day1: 0 hours pre-dose
|
5.55 μg/mL
Standard Deviation 2.34
|
—
|
—
|
|
Mean Serum Concentration (Ctrough) of Crizanlizumab
Week 39 Day1: 672 hours post-dose
|
5.16 μg/mL
Standard Deviation 2.10
|
—
|
—
|
|
Mean Serum Concentration (Ctrough) of Crizanlizumab
Week 53 Day1: 672 hours post-dose
|
15.2 μg/mL
Standard Deviation 5.18
|
—
|
—
|
Adverse Events
Crizanlizumab + Standard of Care
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Standard of Care (SOC)
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
All Participants
Serious events: 4 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Crizanlizumab + Standard of Care
n=29 participants at risk
5 mg/kg by intravenous (i.v.) infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51 in addition to their usual standard of care treatment
|
Standard of Care (SOC)
n=28 participants at risk
Patients in the standard of care alone arm will continue to receive their usual standard of care treatment.
|
All Participants
n=57 participants at risk
All Participants enrolled in the trial from whom safety was collected.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Sickle cell anaemia with crisis
|
3.4%
1/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
3.6%
1/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
3.5%
2/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
3.6%
1/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
1.8%
1/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
|
Infections and infestations
Influenza
|
3.4%
1/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
0.00%
0/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
1.8%
1/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
3.6%
1/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
1.8%
1/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
Other adverse events
| Measure |
Crizanlizumab + Standard of Care
n=29 participants at risk
5 mg/kg by intravenous (i.v.) infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51 in addition to their usual standard of care treatment
|
Standard of Care (SOC)
n=28 participants at risk
Patients in the standard of care alone arm will continue to receive their usual standard of care treatment.
|
All Participants
n=57 participants at risk
All Participants enrolled in the trial from whom safety was collected.
|
|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
7.1%
2/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
3.5%
2/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
|
Gastrointestinal disorders
Constipation
|
10.3%
3/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
0.00%
0/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
5.3%
3/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
7.1%
2/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
3.5%
2/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.9%
2/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
0.00%
0/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
3.5%
2/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
|
Gastrointestinal disorders
Nausea
|
13.8%
4/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
17.9%
5/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
15.8%
9/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
25.0%
7/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
14.0%
8/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
|
General disorders
Fatigue
|
6.9%
2/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
10.7%
3/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
8.8%
5/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
|
General disorders
Oedema peripheral
|
0.00%
0/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
10.7%
3/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
5.3%
3/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
|
General disorders
Pyrexia
|
10.3%
3/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
7.1%
2/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
8.8%
5/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
|
Infections and infestations
COVID-19
|
24.1%
7/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
14.3%
4/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
19.3%
11/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
|
Infections and infestations
Influenza
|
13.8%
4/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
14.3%
4/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
14.0%
8/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
|
Infections and infestations
Lower respiratory tract infection
|
6.9%
2/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
0.00%
0/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
3.5%
2/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
|
Infections and infestations
Pharyngitis
|
6.9%
2/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
3.6%
1/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
5.3%
3/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
|
Infections and infestations
Subcutaneous abscess
|
6.9%
2/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
0.00%
0/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
3.5%
2/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
|
Infections and infestations
Tooth infection
|
13.8%
4/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
0.00%
0/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
7.0%
4/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
|
Infections and infestations
Urinary tract infection
|
10.3%
3/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
0.00%
0/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
5.3%
3/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.2%
5/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
10.7%
3/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
14.0%
8/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.3%
3/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
10.7%
3/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
10.5%
6/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
|
Nervous system disorders
Headache
|
20.7%
6/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
14.3%
4/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
17.5%
10/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
|
Nervous system disorders
Migraine
|
6.9%
2/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
3.6%
1/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
5.3%
3/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
2/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
14.3%
4/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
10.5%
6/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
7.1%
2/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
3.5%
2/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.9%
2/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
0.00%
0/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
3.5%
2/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.3%
3/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
3.6%
1/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
7.0%
4/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.9%
2/29 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
0.00%
0/28 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
3.5%
2/57 • Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial \& safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions \& does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e., data from all sites) in clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER