Trial Outcomes & Findings for Dose-Escalation Study of ALXN1210 IV in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) (NCT NCT02598583)
NCT ID: NCT02598583
Last Updated: 2022-05-16
Results Overview
Baseline was defined as the average of all available assessments prior to first ALXN1210 infusion.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Baseline, Day 169
Results posted on
2022-05-16
Participant Flow
Participant milestones
| Measure |
ALXN1210 Cohort 1
Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
|
ALXN1210 Cohort 2
Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
|
|---|---|---|
|
Primary Evaluation Period
STARTED
|
6
|
7
|
|
Primary Evaluation Period
COMPLETED
|
6
|
7
|
|
Primary Evaluation Period
NOT COMPLETED
|
0
|
0
|
|
Extension Period
STARTED
|
6
|
7
|
|
Extension Period
COMPLETED
|
5
|
7
|
|
Extension Period
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
ALXN1210 Cohort 1
Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
|
ALXN1210 Cohort 2
Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
|
|---|---|---|
|
Extension Period
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Dose-Escalation Study of ALXN1210 IV in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Baseline characteristics by cohort
| Measure |
ALXN1210 Cohort 1
n=6 Participants
Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
|
ALXN1210 Cohort 2
n=7 Participants
Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.1 years
STANDARD_DEVIATION 10.87 • n=5 Participants
|
43.6 years
STANDARD_DEVIATION 13.48 • n=7 Participants
|
42.4 years
STANDARD_DEVIATION 11.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 169Population: The full analysis set included all enrolled participants who received at least 1 dose of ALXN1210 and who had a Baseline measurement with at least 1 LDH measurement post-first ALXN1210 dose. Data were summarized only for participants with assessment at Baseline and the specified time point.
Baseline was defined as the average of all available assessments prior to first ALXN1210 infusion.
Outcome measures
| Measure |
ALXN1210 Cohort 1
n=6 Participants
Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
|
ALXN1210 Cohort 2
n=7 Participants
Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
|
|---|---|---|
|
Percent Change In Lactate Dehydrogenase (LDH) Levels From Baseline To Day 169
|
-85.952 percent change
Standard Deviation 3.1897
|
-84.736 percent change
Standard Deviation 3.7736
|
SECONDARY outcome
Timeframe: Baseline, Day 169, Day 1821Population: The full analysis set included all enrolled participants who received at least 1 dose of ALXN1210 and who had a Baseline measurement with at least 1 free hemoglobin measurement post-first ALXN1210 dose. Data were summarized only for participants with assessment at Baseline and the specified time point.
Baseline was defined as the last non-missing assessment value prior to the first ALXN1210 infusion.
Outcome measures
| Measure |
ALXN1210 Cohort 1
n=6 Participants
Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
|
ALXN1210 Cohort 2
n=7 Participants
Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
|
|---|---|---|
|
Percent Change In Free Hemoglobin Levels From Baseline To Day 169 And Day 1821
Day 169
|
-22.335 percent change
Standard Deviation 42.2249
|
-43.969 percent change
Standard Deviation 24.7674
|
|
Percent Change In Free Hemoglobin Levels From Baseline To Day 169 And Day 1821
Day 1821
|
-35.062 percent change
Standard Deviation 30.9356
|
24.435 percent change
Standard Deviation 178.7882
|
SECONDARY outcome
Timeframe: Baseline, Day 169, Day 1821Population: The full analysis set included all enrolled participants who received at least 1 dose of ALXN1210 and who had a Baseline measurement with at least 1 haptoglobin measurement post-first ALXN1210 dose. Data were summarized only for participants with assessment at Baseline and the specified time point.
Baseline was defined as the last non-missing assessment value prior to the first ALXN1210 infusion.
Outcome measures
| Measure |
ALXN1210 Cohort 1
n=6 Participants
Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
|
ALXN1210 Cohort 2
n=7 Participants
Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
|
|---|---|---|
|
Percent Change In Haptoglobin Levels From Baseline To Day 169 And Day 1821
Day 169
|
40.0000 percent change
Standard Deviation 55.13620
|
17.1429 percent change
Standard Deviation 45.35574
|
|
Percent Change In Haptoglobin Levels From Baseline To Day 169 And Day 1821
Day 1821
|
72.0000 percent change
Standard Deviation 144.81022
|
62.5000 percent change
Standard Deviation 125.00000
|
SECONDARY outcome
Timeframe: Baseline, Day 169, Day 1821Population: The full analysis set included all enrolled participants who received at least 1 dose of ALXN1210 and who had a Baseline measurement with at least 1 reticulocyte/erythrocyte count measurement post-first ALXN1210 dose. Data were summarized only for participants with assessment at Baseline and the specified time point.
Baseline was defined as the last non-missing assessment value prior to the first ALXN1210 infusion.
Outcome measures
| Measure |
ALXN1210 Cohort 1
n=6 Participants
Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
|
ALXN1210 Cohort 2
n=7 Participants
Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
|
|---|---|---|
|
Percent Change In Reticulocyte/Erythrocyte Count From Baseline To Day 169 And Day 1821
Day 169
|
-21.203 percent change
Standard Deviation 14.1461
|
28.784 percent change
Standard Deviation 54.2636
|
|
Percent Change In Reticulocyte/Erythrocyte Count From Baseline To Day 169 And Day 1821
Day 1821
|
-32.736 percent change
Standard Deviation 18.8997
|
9.763 percent change
Standard Deviation 22.5892
|
SECONDARY outcome
Timeframe: Baseline, Day 169, Day 1933Population: The full analysis set included all enrolled participants who received at least 1 dose of ALXN1210 and who had a Baseline measurement with at least 1 PNH RBC clones measurement post-first ALXN1210 dose. Data were summarized only for participants with assessment at Baseline and the specified time point.
Baseline was defined as the last non-missing assessment value prior to the first ALXN1210 infusion.
Outcome measures
| Measure |
ALXN1210 Cohort 1
n=6 Participants
Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
|
ALXN1210 Cohort 2
n=7 Participants
Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
|
|---|---|---|
|
Percent Change In Paroxysmal Nocturnal Hemoglobinuria (PNH) Red Blood Cell (RBC) Clones From Baseline To Day 169 And Day 1933
Day 169
|
7.873 percent change
Standard Deviation 19.3064
|
25.840 percent change
Standard Deviation 62.9677
|
|
Percent Change In Paroxysmal Nocturnal Hemoglobinuria (PNH) Red Blood Cell (RBC) Clones From Baseline To Day 169 And Day 1933
Day 1933
|
15.927 percent change
Standard Deviation 34.8796
|
13.960 percent change
Standard Deviation 78.9414
|
SECONDARY outcome
Timeframe: Baseline, Day 169, Day 1821Population: The full analysis set included all enrolled participants who received at least 1 dose of ALXN1210 and who had a Baseline measurement with at least 1 D-dimer measurement post-first ALXN1210 dose. Data were summarized only for participants with assessment at Baseline and the specified time point.
Baseline was defined as the last non-missing assessment value prior to the first ALXN1210 infusion.
Outcome measures
| Measure |
ALXN1210 Cohort 1
n=6 Participants
Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
|
ALXN1210 Cohort 2
n=7 Participants
Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
|
|---|---|---|
|
Percent Change In D-dimer Levels From Baseline To Day 169 And Day 1821
Day 169
|
-27.42 percent change
Standard Deviation 40.015
|
-0.49 percent change
Standard Deviation 73.116
|
|
Percent Change In D-dimer Levels From Baseline To Day 169 And Day 1821
Day 1821
|
-12.74 percent change
Standard Deviation 54.821
|
25.15 percent change
Standard Deviation 43.861
|
SECONDARY outcome
Timeframe: Baseline, Day 169, Day 1821Population: The full analysis set included all enrolled participants who received at least 1 dose of ALXN1210 and who had a Baseline measurement with at least 1 clinical manifestation of PNH assessed post-first ALXN1210 dose. Data were summarized only for participants with assessment at Baseline and the specified time point. ED affects only male participants.
Clinical manifestations are defined as fatigue, abdominal pain, dyspnea, dysphagia, chest pain, and erectile dysfunction (ED) by cohort. Improvement is defined as present at baseline and absent at Day 169 endpoint. Worsening is defined as absent at Baseline and present at Day 169 endpoint.
Outcome measures
| Measure |
ALXN1210 Cohort 1
n=6 Participants
Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
|
ALXN1210 Cohort 2
n=7 Participants
Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
|
|---|---|---|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Fatigue: Day 1821 · Worsened from Baseline
|
0 Participants
|
0 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Dysphagia: Day 169 · Worsened from Baseline
|
0 Participants
|
0 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Dysphagia: Day 169 · No Change/Not Applicable
|
6 Participants
|
6 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Fatigue: Day 169 · Improved from Baseline
|
1 Participants
|
1 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Fatigue: Day 169 · Worsened from Baseline
|
0 Participants
|
0 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Fatigue: Day 169 · No Change/Not Applicable
|
5 Participants
|
6 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Fatigue: Day 1821 · Improved from Baseline
|
2 Participants
|
1 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Fatigue: Day 1821 · No Change/Not Applicable
|
3 Participants
|
3 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Abdominal pain: Day 169 · Improved from Baseline
|
0 Participants
|
3 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Abdominal pain: Day 169 · Worsened from Baseline
|
0 Participants
|
0 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Abdominal pain: Day 169 · No Change/Not Applicable
|
6 Participants
|
4 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Abdominal pain: Day 1821 · Improved from Baseline
|
0 Participants
|
2 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Abdominal pain: Day 1821 · Worsened from Baseline
|
0 Participants
|
0 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Abdominal pain: Day 1821 · No Change/Not Applicable
|
5 Participants
|
2 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Dyspnoea: Day 169 · Improved from Baseline
|
2 Participants
|
1 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Dyspnoea: Day 169 · Worsened from Baseline
|
0 Participants
|
0 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Dyspnoea: Day 169 · No Change/Not Applicable
|
4 Participants
|
6 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Dyspnoea: Day 1821 · Improved from Baseline
|
2 Participants
|
1 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Dyspnoea: Day 1821 · Worsened from Baseline
|
0 Participants
|
0 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Dyspnoea: Day 1821 · No Change/Not Applicable
|
3 Participants
|
3 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Dysphagia: Day 169 · Improved from Baseline
|
0 Participants
|
1 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Dysphagia: Day 1821 · Improved from Baseline
|
0 Participants
|
0 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Dysphagia: Day 1821 · Worsened from Baseline
|
0 Participants
|
0 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Dysphagia: Day 1821 · No Change/Not Applicable
|
5 Participants
|
4 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Chest pain: Day 169 · Improved from Baseline
|
0 Participants
|
2 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Chest pain: Day 169 · Worsened from Baseline
|
0 Participants
|
0 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Chest pain: Day 169 · No Change/Not Applicable
|
6 Participants
|
5 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Chest pain: Day 1821 · Improved from Baseline
|
0 Participants
|
1 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Chest pain: Day 1821 · Worsened from Baseline
|
0 Participants
|
0 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
Chest pain: Day 1821 · No Change/Not Applicable
|
5 Participants
|
3 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
ED: Day 169 · Improved from Baseline
|
1 Participants
|
0 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
ED: Day 169 · Worsened from Baseline
|
0 Participants
|
0 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
ED: Day 169 · No Change/Not Applicable
|
5 Participants
|
7 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
ED: Day 1821 · Improved from Baseline
|
1 Participants
|
0 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
ED: Day 1821 · Worsened from Baseline
|
0 Participants
|
0 Participants
|
|
Change In Clinical Manifestations Of PNH From Baseline To Day 169 And Day 1821
ED: Day 1821 · No Change/Not Applicable
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Pharmacokinetics (PK) Analysis Set: all participants who had sufficient serum concentration data to enable the calculation of PK parameters.
AUCt reported in hours\*microgram/milliliter (h\*ug/mL).
Outcome measures
| Measure |
ALXN1210 Cohort 1
n=2 Participants
Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
|
ALXN1210 Cohort 2
n=4 Participants
Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
|
|---|---|---|
|
Area Under The Serum Concentration-versus-time-curve From Time 0 (Dosing) To The Last Quantifiable Concentration (AUCt) At Day 1
|
14273.95 h*ug/mL
Standard Deviation 4907.438
|
42366.62 h*ug/mL
Standard Deviation 3710.120
|
SECONDARY outcome
Timeframe: Day 1Population: PK Analysis Set: all participants who had sufficient serum concentration data to enable the calculation of PK parameters.
Outcome measures
| Measure |
ALXN1210 Cohort 1
n=2 Participants
Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
|
ALXN1210 Cohort 2
n=4 Participants
Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
|
|---|---|---|
|
AUCt/ Dose-normalized (D) At Day 1
|
35.68 h*ug/mL/mg
Standard Deviation 12.269
|
70.61 h*ug/mL/mg
Standard Deviation 6.184
|
SECONDARY outcome
Timeframe: Day 141Population: PK Analysis Set: all participants who had sufficient serum concentration data to enable the calculation of PK parameters.
Outcome measures
| Measure |
ALXN1210 Cohort 1
n=2 Participants
Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
|
ALXN1210 Cohort 2
n=4 Participants
Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
|
|---|---|---|
|
Area Under The Serum Concentration-versus-time-curve From Time 0 (Dosing) To The End Of The Dosing Interval (AUCtau) At Day 141
|
216515.22 h*ug/mL
Standard Deviation 68099.982
|
217936.47 h*ug/mL
Standard Deviation 31023.979
|
SECONDARY outcome
Timeframe: Day 141Population: PK Analysis Set: all participants who had sufficient serum concentration data to enable the calculation of PK parameters
Outcome measures
| Measure |
ALXN1210 Cohort 1
n=2 Participants
Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
|
ALXN1210 Cohort 2
n=4 Participants
Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
|
|---|---|---|
|
AUCtau/D At Day 141
|
240.57 h*ug/mL/mg
Standard Deviation 75.667
|
242.15 h*ug/mL/mg
Standard Deviation 34.471
|
SECONDARY outcome
Timeframe: Day 1 and Day 141Population: PK Analysis Set: all participants who had sufficient serum concentration data to enable the calculation of PK parameters.
Outcome measures
| Measure |
ALXN1210 Cohort 1
n=2 Participants
Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
|
ALXN1210 Cohort 2
n=4 Participants
Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
|
|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) At Day 1 And Day 141
Day 1
|
114.00 ug/mL
Standard Deviation 15.556
|
203.50 ug/mL
Standard Deviation 10.279
|
|
Maximum Observed Serum Concentration (Cmax) At Day 1 And Day 141
Day 141
|
514.00 ug/mL
Standard Deviation 147.078
|
512.25 ug/mL
Standard Deviation 64.958
|
SECONDARY outcome
Timeframe: Day 1 and Day 141Population: PK Analysis Set: all participants who had sufficient serum concentration data to enable the calculation of PK parameters.
Outcome measures
| Measure |
ALXN1210 Cohort 1
n=2 Participants
Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
|
ALXN1210 Cohort 2
n=4 Participants
Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
|
|---|---|---|
|
Cmax/D At Day 1 And Day 141
Day 1
|
0.29 ug/mL/mg
Standard Deviation 0.039
|
0.34 ug/mL/mg
Standard Deviation 0.017
|
|
Cmax/D At Day 1 And Day 141
Day 141
|
0.57 ug/mL/mg
Standard Deviation 0.163
|
0.57 ug/mL/mg
Standard Deviation 0.072
|
SECONDARY outcome
Timeframe: Day 1 and Day 141Population: PK Analysis Set: all participants who had sufficient serum concentration data to enable the calculation of PK parameters.
Outcome measures
| Measure |
ALXN1210 Cohort 1
n=2 Participants
Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
|
ALXN1210 Cohort 2
n=4 Participants
Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
|
|---|---|---|
|
Concentration At The End Of The Dosage Interval (Ctrough) At Day 1 And At Day 141
Day 1
|
73.25 ug/mL
Standard Deviation 18.173
|
80.50 ug/mL
Standard Deviation 6.541
|
|
Concentration At The End Of The Dosage Interval (Ctrough) At Day 1 And At Day 141
Day 141
|
243.50 ug/mL
Standard Deviation 126.572
|
204.00 ug/mL
Standard Deviation 56.586
|
SECONDARY outcome
Timeframe: Day 1 and Day 141Population: PK Analysis Set: all participants who had sufficient serum concentration data to enable the calculation of PK parameters.
Outcome measures
| Measure |
ALXN1210 Cohort 1
n=2 Participants
Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
|
ALXN1210 Cohort 2
n=4 Participants
Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
|
|---|---|---|
|
Time To Maximum Observed Serum Concentration (Tmax) At Day 1 And Day 141
Day 1
|
2.38 h
Standard Deviation 2.404
|
1.88 h
Standard Deviation 0.957
|
|
Time To Maximum Observed Serum Concentration (Tmax) At Day 1 And Day 141
Day 141
|
4.03 h
Standard Deviation 0.035
|
2.40 h
Standard Deviation 1.124
|
SECONDARY outcome
Timeframe: Baseline, Day 1709Population: Pharmacodynamics (PD) Analysis Set: all participants who had a measurement both before and after the first dose of ravulizumab.
Outcome measures
| Measure |
ALXN1210 Cohort 1
n=5 Participants
Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
|
ALXN1210 Cohort 2
n=5 Participants
Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
|
|---|---|---|
|
Percent Change In Chicken Red Blood Cell (cRBC) Hemolysis From Baseline To Day 1709
|
-72.316 percent change
Standard Deviation 19.0919
|
-97.314 percent change
Standard Deviation 3.2298
|
SECONDARY outcome
Timeframe: Baseline, Day 1709Population: PD Analysis Set: all participants who had a measurement both before and after the first dose of ravulizumab.
Outcome measures
| Measure |
ALXN1210 Cohort 1
n=5 Participants
Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
|
ALXN1210 Cohort 2
n=5 Participants
Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
|
|---|---|---|
|
Percent Change In Free Complement Component 5 (C5) Concentration From Baseline To Day 1709
|
-99.839 percent change
Standard Deviation 0.0130
|
-99.802 percent change
Standard Deviation 0.0950
|
SECONDARY outcome
Timeframe: Baseline, Day 1709Population: PD Analysis Set: all participants who had a measurement both before and after the first dose of ravulizumab.
Outcome measures
| Measure |
ALXN1210 Cohort 1
n=5 Participants
Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
|
ALXN1210 Cohort 2
n=5 Participants
Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
|
|---|---|---|
|
Percent Change In Total C5 Concentration From Baseline To Day 1709
|
65.852 percent change
Standard Deviation 31.2054
|
86.676 percent change
Standard Deviation 24.6721
|
SECONDARY outcome
Timeframe: Day 1821Population: Immunogenicity Analysis Set: all participants who had an ADA sample both before and after the first dose of ravulizumab.
Outcome measures
| Measure |
ALXN1210 Cohort 1
n=6 Participants
Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
|
ALXN1210 Cohort 2
n=7 Participants
Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
|
|---|---|---|
|
Participants Experiencing Antidrug Antibodies (ADAs)
|
0 Participants
|
0 Participants
|
POST_HOC outcome
Timeframe: Baseline, Day 1821Population: The full analysis set included all enrolled participants who received at least 1 dose of ALXN1210 and who had a Baseline measurement with at least 1 LDH measurement post-first ALXN1210 dose. Data were summarized only for participants with assessment at Baseline and the specified time point.
Baseline was defined as the average of all available assessments prior to first ALXN1210 infusion.
Outcome measures
| Measure |
ALXN1210 Cohort 1
n=5 Participants
Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
|
ALXN1210 Cohort 2
n=4 Participants
Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
|
|---|---|---|
|
Percent Change In LDH Levels From Baseline To Day 1821
|
-86.244 percent change
Standard Deviation 4.7348
|
-84.413 percent change
Standard Deviation 3.6473
|
Adverse Events
ALXN1210 Cohort 1
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
ALXN1210 Cohort 2
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ALXN1210 Cohort 1
n=6 participants at risk
Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
|
ALXN1210 Cohort 2
n=7 participants at risk
Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
|
|---|---|---|
|
Infections and infestations
Meningococcal infection
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Infections and infestations
Parvovirus infection
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Infections and infestations
Tubo-ovarian abscess
|
16.7%
1/6 • Day 1 through Day 1957
|
0.00%
0/7 • Day 1 through Day 1957
|
|
Hepatobiliary disorders
Bile duct stone
|
16.7%
1/6 • Day 1 through Day 1957
|
0.00%
0/7 • Day 1 through Day 1957
|
|
Hepatobiliary disorders
Cholangitis
|
16.7%
1/6 • Day 1 through Day 1957
|
0.00%
0/7 • Day 1 through Day 1957
|
|
Hepatobiliary disorders
Cholangitis acute
|
16.7%
1/6 • Day 1 through Day 1957
|
0.00%
0/7 • Day 1 through Day 1957
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Day 1 through Day 1957
|
28.6%
2/7 • Day 1 through Day 1957
|
|
Injury, poisoning and procedural complications
Contusion
|
16.7%
1/6 • Day 1 through Day 1957
|
0.00%
0/7 • Day 1 through Day 1957
|
Other adverse events
| Measure |
ALXN1210 Cohort 1
n=6 participants at risk
Induction phase: a) 400 milligram (mg) on Day 1 and Day 8, 600 mg on Day 15; or b) 600 mg on Day 1, 600 mg on Day 15 Maintenance phase: the first of 5 doses of 900 mg on Day 29 and every 4 weeks thereafter
|
ALXN1210 Cohort 2
n=7 participants at risk
Induction phase: 600 mg on Day 1, 900 mg on Day 15 Maintenance phase: the first of 5 doses of 1800 mg on Day 29 and every 4 weeks thereafter
|
|---|---|---|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Day 1 through Day 1957
|
57.1%
4/7 • Day 1 through Day 1957
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • Day 1 through Day 1957
|
0.00%
0/7 • Day 1 through Day 1957
|
|
Nervous system disorders
Neuropathy peripheral
|
16.7%
1/6 • Day 1 through Day 1957
|
0.00%
0/7 • Day 1 through Day 1957
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Infections and infestations
Upper respiratory tract infection
|
50.0%
3/6 • Day 1 through Day 1957
|
85.7%
6/7 • Day 1 through Day 1957
|
|
Infections and infestations
Hordeolum
|
0.00%
0/6 • Day 1 through Day 1957
|
28.6%
2/7 • Day 1 through Day 1957
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Day 1 through Day 1957
|
28.6%
2/7 • Day 1 through Day 1957
|
|
Infections and infestations
Laryngitis
|
16.7%
1/6 • Day 1 through Day 1957
|
28.6%
2/7 • Day 1 through Day 1957
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • Day 1 through Day 1957
|
28.6%
2/7 • Day 1 through Day 1957
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
3/6 • Day 1 through Day 1957
|
28.6%
2/7 • Day 1 through Day 1957
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Day 1 through Day 1957
|
42.9%
3/7 • Day 1 through Day 1957
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Day 1 through Day 1957
|
28.6%
2/7 • Day 1 through Day 1957
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/6 • Day 1 through Day 1957
|
28.6%
2/7 • Day 1 through Day 1957
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Day 1 through Day 1957
|
28.6%
2/7 • Day 1 through Day 1957
|
|
General disorders
Fatigue
|
33.3%
2/6 • Day 1 through Day 1957
|
28.6%
2/7 • Day 1 through Day 1957
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
General disorders
Pain
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
General disorders
Pyrexia
|
50.0%
3/6 • Day 1 through Day 1957
|
0.00%
0/7 • Day 1 through Day 1957
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
2/6 • Day 1 through Day 1957
|
28.6%
2/7 • Day 1 through Day 1957
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
16.7%
1/6 • Day 1 through Day 1957
|
0.00%
0/7 • Day 1 through Day 1957
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Respiratory, thoracic and mediastinal disorders
Reflux laryngitis
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Day 1 through Day 1957
|
28.6%
2/7 • Day 1 through Day 1957
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • Day 1 through Day 1957
|
0.00%
0/7 • Day 1 through Day 1957
|
|
Investigations
Blood creatinine increased
|
16.7%
1/6 • Day 1 through Day 1957
|
0.00%
0/7 • Day 1 through Day 1957
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • Day 1 through Day 1957
|
28.6%
2/7 • Day 1 through Day 1957
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • Day 1 through Day 1957
|
28.6%
2/7 • Day 1 through Day 1957
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • Day 1 through Day 1957
|
28.6%
2/7 • Day 1 through Day 1957
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Infections and infestations
Conjunctivitis
|
16.7%
1/6 • Day 1 through Day 1957
|
0.00%
0/7 • Day 1 through Day 1957
|
|
Infections and infestations
Otitis media
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Infections and infestations
Parvovirus infection
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Infections and infestations
Rash pustular
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Infections and infestations
Chlamydial infection
|
16.7%
1/6 • Day 1 through Day 1957
|
0.00%
0/7 • Day 1 through Day 1957
|
|
Infections and infestations
Cystitis
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Infections and infestations
Enterocolitis viral
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Infections and infestations
Eye infection
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Infections and infestations
Furuncle
|
16.7%
1/6 • Day 1 through Day 1957
|
0.00%
0/7 • Day 1 through Day 1957
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Infections and infestations
Laryngopharyngitis
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Infections and infestations
Nipple infection
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Infections and infestations
Oophoritis
|
16.7%
1/6 • Day 1 through Day 1957
|
0.00%
0/7 • Day 1 through Day 1957
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Infections and infestations
Tooth infection
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
General disorders
Face oedema
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
General disorders
Puncture site pain
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
2/6 • Day 1 through Day 1957
|
28.6%
2/7 • Day 1 through Day 1957
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • Day 1 through Day 1957
|
28.6%
2/7 • Day 1 through Day 1957
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Gastrointestinal disorders
Colitis
|
16.7%
1/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Day 1 through Day 1957
|
0.00%
0/7 • Day 1 through Day 1957
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis atrophic
|
16.7%
1/6 • Day 1 through Day 1957
|
0.00%
0/7 • Day 1 through Day 1957
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.7%
1/6 • Day 1 through Day 1957
|
0.00%
0/7 • Day 1 through Day 1957
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Investigations
Blood creatine phosphokinase increased
|
16.7%
1/6 • Day 1 through Day 1957
|
0.00%
0/7 • Day 1 through Day 1957
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Cardiac disorders
Atrial fibrillation
|
16.7%
1/6 • Day 1 through Day 1957
|
0.00%
0/7 • Day 1 through Day 1957
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Hepatobiliary disorders
Cholangitis
|
16.7%
1/6 • Day 1 through Day 1957
|
0.00%
0/7 • Day 1 through Day 1957
|
|
Injury, poisoning and procedural complications
Contusion
|
16.7%
1/6 • Day 1 through Day 1957
|
0.00%
0/7 • Day 1 through Day 1957
|
|
Injury, poisoning and procedural complications
Face injury
|
16.7%
1/6 • Day 1 through Day 1957
|
0.00%
0/7 • Day 1 through Day 1957
|
|
Injury, poisoning and procedural complications
Hand fracture
|
16.7%
1/6 • Day 1 through Day 1957
|
0.00%
0/7 • Day 1 through Day 1957
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Day 1 through Day 1957
|
28.6%
2/7 • Day 1 through Day 1957
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Eye disorders
Blepharitis
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Renal and urinary disorders
Haematuria
|
16.7%
1/6 • Day 1 through Day 1957
|
0.00%
0/7 • Day 1 through Day 1957
|
|
Renal and urinary disorders
Paroxysmal nocturnal haemoglobinuria
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
16.7%
1/6 • Day 1 through Day 1957
|
0.00%
0/7 • Day 1 through Day 1957
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • Day 1 through Day 1957
|
14.3%
1/7 • Day 1 through Day 1957
|
Additional Information
Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.
Phone: +1 855-752-2356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place