Trial Outcomes & Findings for Safety and Efficacy of ALD518 for Reducing Oral Mucositis in Head and Neck Cancer Subjects (NCT NCT01403064)
NCT ID: NCT01403064
Last Updated: 2021-05-11
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
76 participants
Primary outcome timeframe
Up to 15 months
Results posted on
2021-05-11
Participant Flow
Participant milestones
| Measure |
Placebo
0.9% saline administered as two intravenous infusions (IV) 3 weeks apart
|
ALD518 (160 mg, OL)
ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment
|
ALD518 (160 mg, R)
ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg, R)
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
7
|
23
|
22
|
|
Overall Study
COMPLETED
|
23
|
7
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
4
|
3
|
Reasons for withdrawal
| Measure |
Placebo
0.9% saline administered as two intravenous infusions (IV) 3 weeks apart
|
ALD518 (160 mg, OL)
ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment
|
ALD518 (160 mg, R)
ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg, R)
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
|
Overall Study
Other
|
1
|
0
|
2
|
1
|
Baseline Characteristics
Safety and Efficacy of ALD518 for Reducing Oral Mucositis in Head and Neck Cancer Subjects
Baseline characteristics by cohort
| Measure |
Placebo
n=24 Participants
0.9% saline administered as two intravenous infusions (IV) 3 weeks apart
|
ALD518 (160 mg, OL)
n=7 Participants
ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment
|
ALD518 (160 mg, R)
n=23 Participants
ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg, R)
n=22 Participants
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 7.92 • n=5 Participants
|
56.3 years
STANDARD_DEVIATION 11.93 • n=7 Participants
|
58.6 years
STANDARD_DEVIATION 7.43 • n=5 Participants
|
55.1 years
STANDARD_DEVIATION 7.18 • n=4 Participants
|
57.4 years
STANDARD_DEVIATION 8.00 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Region of Enrollment
Austria
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
8 participants
n=4 Participants
|
26 participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
5 participants
n=5 Participants
|
4 participants
n=4 Participants
|
12 participants
n=21 Participants
|
|
Region of Enrollment
Australia
|
9 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
15 participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
5 participants
n=5 Participants
|
0 participants
n=7 Participants
|
10 participants
n=5 Participants
|
2 participants
n=4 Participants
|
17 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 15 monthsPopulation: Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatments they received. As pre-specified, the two treatment groups that received 160 mg (open label and randomized) were combined into one 160 mg group for analysis purposes of this endpoint.
Outcome measures
| Measure |
Placebo
n=23 Participants
0.9% saline administered as two intravenous infusions (IV) 3 weeks apart
|
ALD518 (160 mg)
n=32 Participants
ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment or ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg)
n=21 Participants
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg, R)
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
|---|---|---|---|---|
|
Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities
Clinically significant laboratory abnormalities
|
0 percentage of participants
|
6.3 percentage of participants
|
4.8 percentage of participants
|
—
|
|
Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities
Adverse events (AEs)
|
95.7 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
—
|
|
Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities
Serious adverse events
|
30.4 percentage of participants
|
46.9 percentage of participants
|
38.1 percentage of participants
|
—
|
|
Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities
Treatment-related AEs
|
52.2 percentage of participants
|
65.6 percentage of participants
|
57.1 percentage of participants
|
—
|
|
Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities
AEs leading to treatment discontinuation
|
0 percentage of participants
|
3.1 percentage of participants
|
4.8 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Up to 15 monthsPopulation: SP. As pre-specified, the two treatment groups that received 160 mg (open label and randomized) were combined into one 160 mg group for analysis purposes of this endpoint.
Outcome measures
| Measure |
Placebo
n=23 Participants
0.9% saline administered as two intravenous infusions (IV) 3 weeks apart
|
ALD518 (160 mg)
n=32 Participants
ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment or ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg)
n=21 Participants
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg, R)
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities
Adverse events (AEs)
|
22 participants
|
32 participants
|
21 participants
|
—
|
|
Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities
Serious adverse events
|
7 participants
|
15 participants
|
8 participants
|
—
|
|
Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities
Clinically significant laboratory abnormalities
|
0 participants
|
2 participants
|
1 participants
|
—
|
|
Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities
Treatment-related AEs
|
12 participants
|
21 participants
|
12 participants
|
—
|
|
Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities
AEs leading to treatment discontinuation
|
0 participants
|
1 participants
|
1 participants
|
—
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Full Analysis Population (FAP) defined as those randomized subjects who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatments to which they were assigned.
Gray (Gy) is used as a unit of the radiation quantity absorbed dose that measures the energy deposited by ionizing radiation in a unit mass of matter being irradiated, and is used for measuring the delivered dose of ionizing radiation in applications such as radiotherapy. The 55 Gy ulcerative OM assessment is defined as the first ulcerative OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in their cumulative dose of radiation being ≥ 55 Gy
Outcome measures
| Measure |
Placebo
n=24 Participants
0.9% saline administered as two intravenous infusions (IV) 3 weeks apart
|
ALD518 (160 mg)
n=7 Participants
ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment or ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg)
n=23 Participants
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg, R)
n=22 Participants
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
|---|---|---|---|---|
|
Percent of Participants With All Grades of Oral Mucositis (OM) at a Radiation Dose of 55 Gy
|
79.2 percentage of participants
|
71.4 percentage of participants
|
100 percentage of participants
|
77.3 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: FAP
The 55 Gy ulcerative OM assessment is defined as the first ulcerative OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in their cumulative dose of radiation being ≥ 55 Gy
Outcome measures
| Measure |
Placebo
n=24 Participants
0.9% saline administered as two intravenous infusions (IV) 3 weeks apart
|
ALD518 (160 mg)
n=7 Participants
ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment or ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg)
n=23 Participants
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg, R)
n=22 Participants
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
|---|---|---|---|---|
|
Number of Participants With All Grades of OM at a Radiation Dose of 55 Gy
|
19 participants
|
5 participants
|
23 participants
|
17 participants
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: FAP, 3 participants missing data
The ulcerative OM assessment at a specific cumulative radiation dose (35 Gy, 45 Gy, 55 Gy or 65 Gy) is defined as the first ulcerative OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in the specific cumulative dose of radiation being ≥35 Gy, ≥45 Gy, ≥55 Gy or≥ 65 Gy
Outcome measures
| Measure |
Placebo
n=24 Participants
0.9% saline administered as two intravenous infusions (IV) 3 weeks apart
|
ALD518 (160 mg)
n=7 Participants
ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment or ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg)
n=22 Participants
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg, R)
n=20 Participants
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
|---|---|---|---|---|
|
Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy)
35 Gy
|
58.3 percentage of participants
|
85.7 percentage of participants
|
81.8 percentage of participants
|
65.0 percentage of participants
|
|
Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy)
45 Gy
|
87.5 percentage of participants
|
85.7 percentage of participants
|
90.9 percentage of participants
|
75.0 percentage of participants
|
|
Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy)
55 Gy
|
79.2 percentage of participants
|
71.4 percentage of participants
|
100 percentage of participants
|
75.0 percentage of participants
|
|
Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy)
65 Gy
|
83.3 percentage of participants
|
83.3 percentage of participants
|
100 percentage of participants
|
68.8 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: FAP, 3 participants missing data
The ulcerative OM assessment at a specific cumulative radiation dose (35 Gy, 45 Gy, 55 Gy or 65 Gy) is defined as the first ulcerative OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in the specific cumulative dose of radiation being ≥35 Gy, ≥45 Gy, ≥55 Gy or≥ 65 Gy
Outcome measures
| Measure |
Placebo
n=24 Participants
0.9% saline administered as two intravenous infusions (IV) 3 weeks apart
|
ALD518 (160 mg)
n=7 Participants
ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment or ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg)
n=22 Participants
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg, R)
n=20 Participants
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
|---|---|---|---|---|
|
Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy)
55 Gy
|
19 participants
|
5 participants
|
22 participants
|
15 participants
|
|
Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy)
35 Gy
|
14 participants
|
6 participants
|
18 participants
|
13 participants
|
|
Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy)
45 Gy
|
21 participants
|
6 participants
|
20 participants
|
15 participants
|
|
Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy)
65 Gy
|
15 participants
|
5 participants
|
19 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Measured from onset of OM through Week 12Population: FAP, 3 participants missing data
The severe OM assessment at a specific cumulative radiation dose (35 Gy, 45 Gy, 55 Gy or 65 Gy) is defined as the first severe OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in the specific cumulative dose of radiation being ≥35 Gy, ≥45 Gy, ≥55 Gy or≥ 65 Gy
Outcome measures
| Measure |
Placebo
n=24 Participants
0.9% saline administered as two intravenous infusions (IV) 3 weeks apart
|
ALD518 (160 mg)
n=7 Participants
ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment or ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg)
n=22 Participants
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg, R)
n=20 Participants
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
|---|---|---|---|---|
|
Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy)
35 Gy
|
25.0 percentage of participants
|
57.1 percentage of participants
|
27.3 percentage of participants
|
30.0 percentage of participants
|
|
Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy)
45 Gy
|
41.7 percentage of participants
|
71.4 percentage of participants
|
36.4 percentage of participants
|
45.0 percentage of participants
|
|
Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy)
55 Gy
|
50.0 percentage of participants
|
71.4 percentage of participants
|
40.9 percentage of participants
|
55.0 percentage of participants
|
|
Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy)
65 Gy
|
55.6 percentage of participants
|
50.0 percentage of participants
|
63.2 percentage of participants
|
43.8 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: FAP, 3 participants missing data
The severe OM assessment at a specific cumulative radiation dose (35 Gy, 45 Gy, 55 Gy or 65 Gy) is defined as the first severe OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in the specific cumulative dose of radiation being ≥35 Gy, ≥45 Gy, ≥55 Gy or≥ 65 Gy
Outcome measures
| Measure |
Placebo
n=24 Participants
0.9% saline administered as two intravenous infusions (IV) 3 weeks apart
|
ALD518 (160 mg)
n=7 Participants
ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment or ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg)
n=22 Participants
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg, R)
n=20 Participants
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
|---|---|---|---|---|
|
Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy)
35 Gy
|
6 participants
|
4 participants
|
6 participants
|
6 participants
|
|
Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy)
45 Gy
|
10 participants
|
5 participants
|
8 participants
|
9 participants
|
|
Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy)
55 Gy
|
12 participants
|
5 participants
|
9 participants
|
11 participants
|
|
Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy)
65 Gy
|
10 participants
|
3 participants
|
12 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: FAP
Outcome measures
| Measure |
Placebo
n=24 Participants
0.9% saline administered as two intravenous infusions (IV) 3 weeks apart
|
ALD518 (160 mg)
n=7 Participants
ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment or ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg)
n=23 Participants
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg, R)
n=22 Participants
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
|---|---|---|---|---|
|
Duration of Ulcerative and Severe OM
Ulcerative
|
42.0 Days
Standard Deviation 23.17
|
55.1 Days
Standard Deviation 26.57
|
48.3 Days
Standard Deviation 16.71
|
38.0 Days
Standard Deviation 29.53
|
|
Duration of Ulcerative and Severe OM
Severe
|
22.4 Days
Standard Deviation 23.28
|
35.1 Days
Standard Deviation 28.02
|
22.7 Days
Standard Deviation 18.95
|
21.5 Days
Standard Deviation 25.01
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: FAP
Outcome measures
| Measure |
Placebo
n=24 Participants
0.9% saline administered as two intravenous infusions (IV) 3 weeks apart
|
ALD518 (160 mg)
n=7 Participants
ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment or ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg)
n=23 Participants
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg, R)
n=22 Participants
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
|---|---|---|---|---|
|
Time to Onset of Ulcerative and Severe OM
Ulcerative
|
23.7 Days
Standard Deviation 7.05
|
18.7 Days
Standard Deviation 5.32
|
22.9 Days
Standard Deviation 5.97
|
24.3 Days
Standard Deviation 13.37
|
|
Time to Onset of Ulcerative and Severe OM
Severe
|
37.0 Days
Standard Deviation 11.81
|
26.1 Days
Standard Deviation 5.72
|
43.1 Days
Standard Deviation 17.55
|
38.0 Days
Standard Deviation 15.64
|
SECONDARY outcome
Timeframe: Baseline and up to 12 weeksPopulation: SP
Outcome measures
| Measure |
Placebo
n=7 Participants
0.9% saline administered as two intravenous infusions (IV) 3 weeks apart
|
ALD518 (160 mg)
n=23 Participants
ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment or ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg)
n=21 Participants
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg, R)
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
|---|---|---|---|---|
|
ALD518 Plasma Concentration at Varying Weeks
at Baseline
|
0.0 ug/mL
Standard Deviation 0.00
|
0.0 ug/mL
Standard Deviation 0.00
|
0.0 ug/mL
Standard Deviation 0.00
|
—
|
|
ALD518 Plasma Concentration at Varying Weeks
at Week 2
|
24.3 ug/mL
Standard Deviation 9.98
|
20.6 ug/mL
Standard Deviation 3.73
|
32.7 ug/mL
Standard Deviation 5.24
|
—
|
|
ALD518 Plasma Concentration at Varying Weeks
at Week 4
|
18.8 ug/mL
Standard Deviation 6.62
|
40.6 ug/mL
Standard Deviation 7.53
|
80.6 ug/mL
Standard Deviation 20.21
|
—
|
|
ALD518 Plasma Concentration at Varying Weeks
at Week 8 (last day of RT)
|
31.6 ug/mL
Standard Deviation 12.02
|
23.1 ug/mL
Standard Deviation 6.64
|
46.9 ug/mL
Standard Deviation 13.74
|
—
|
|
ALD518 Plasma Concentration at Varying Weeks
at Week 12 (4 weeks post RT)
|
16.8 ug/mL
Standard Deviation 9.54
|
11.5 ug/mL
Standard Deviation 3.10
|
20.6 ug/mL
Standard Deviation 14.42
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to 12 weeksPopulation: FAP
Scored on a scale from 0 (worst possible overall health) to 10 (perfect overall health). Higher scores represent better overall health.
Outcome measures
| Measure |
Placebo
n=24 Participants
0.9% saline administered as two intravenous infusions (IV) 3 weeks apart
|
ALD518 (160 mg)
n=7 Participants
ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment or ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg)
n=23 Participants
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg, R)
n=22 Participants
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
|---|---|---|---|---|
|
Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy)
Baseline
|
6.5 score on a scale
Standard Deviation 1.95
|
8.4 score on a scale
Standard Deviation 1.40
|
7.2 score on a scale
Standard Deviation 1.66
|
6.7 score on a scale
Standard Deviation 2.35
|
|
Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy)
35 Gy (up to 12 weeks)
|
5.2 score on a scale
Standard Deviation 2.08
|
6.6 score on a scale
Standard Deviation 2.07
|
5.2 score on a scale
Standard Deviation 2.05
|
5.5 score on a scale
Standard Deviation 1.91
|
|
Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy)
45 Gy (up to 12 weeks)
|
5.6 score on a scale
Standard Deviation 1.89
|
5.7 score on a scale
Standard Deviation 2.14
|
5.4 score on a scale
Standard Deviation 1.86
|
5.4 score on a scale
Standard Deviation 2.40
|
|
Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy)
55 Gy (up to 12 weeks)
|
5.1 score on a scale
Standard Deviation 1.96
|
5.9 score on a scale
Standard Deviation 2.54
|
5.3 score on a scale
Standard Deviation 2.22
|
5.1 score on a scale
Standard Deviation 2.27
|
|
Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy)
65 Gy (up to 12 weeks)
|
5.6 score on a scale
Standard Deviation 1.79
|
5.7 score on a scale
Standard Deviation 3.08
|
5.3 score on a scale
Standard Deviation 2.11
|
5.6 score on a scale
Standard Deviation 2.37
|
SECONDARY outcome
Timeframe: Baseline and up to 12 weeksPopulation: FAP
The FACT-HN consists of 28 general + 11 head and neck specific items, each rated on a 0 (not at all) to 4 (very much) Likert type scale. The total score ranges from 0 to 148. Higher scores represent better quality of life.
Outcome measures
| Measure |
Placebo
n=24 Participants
0.9% saline administered as two intravenous infusions (IV) 3 weeks apart
|
ALD518 (160 mg)
n=7 Participants
ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment or ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg)
n=23 Participants
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg, R)
n=22 Participants
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
|---|---|---|---|---|
|
Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy)
65 Gy (up to 12 weeks)
|
85.2 score on a scale
Standard Deviation 18.13
|
93.6 score on a scale
Standard Deviation 27.50
|
86.5 score on a scale
Standard Deviation 18.00
|
86.5 score on a scale
Standard Deviation 23.95
|
|
Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy)
Baseline
|
116.5 score on a scale
Standard Deviation 15.86
|
129.4 score on a scale
Standard Deviation 12.63
|
113.8 score on a scale
Standard Deviation 19.53
|
111.3 score on a scale
Standard Deviation 20.94
|
|
Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy)
35 Gy (up to 12 weeks)
|
92.9 score on a scale
Standard Deviation 20.14
|
100.3 score on a scale
Standard Deviation 24.14
|
96.2 score on a scale
Standard Deviation 21.18
|
92.2 score on a scale
Standard Deviation 19.96
|
|
Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy)
45 Gy (up to 12 weeks)
|
90.6 score on a scale
Standard Deviation 18.18
|
94.7 score on a scale
Standard Deviation 30.14
|
89.7 score on a scale
Standard Deviation 23.49
|
86.6 score on a scale
Standard Deviation 21.34
|
|
Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy)
55 Gy (up to 12 weeks)
|
89.6 score on a scale
Standard Deviation 19.36
|
82.3 score on a scale
Standard Deviation 17.79
|
84.4 score on a scale
Standard Deviation 25.67
|
81.1 score on a scale
Standard Deviation 22.13
|
SECONDARY outcome
Timeframe: Baseline and up to 12 weeksPopulation: FAP
The responses to the 13 items on the FACIT-F questionnaire are each measured on a 5-point Likert scale from 0 (not at all fatigued) to 4 (very much fatigued). The total score ranges from 0 to 52. Higher scores represent less fatigue.
Outcome measures
| Measure |
Placebo
n=24 Participants
0.9% saline administered as two intravenous infusions (IV) 3 weeks apart
|
ALD518 (160 mg)
n=7 Participants
ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment or ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg)
n=23 Participants
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg, R)
n=22 Participants
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
|---|---|---|---|---|
|
Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy)
Baseline
|
42.5 score on a scale
Standard Deviation 7.26
|
47.6 score on a scale
Standard Deviation 3.26
|
42.6 score on a scale
Standard Deviation 8.61
|
39.7 score on a scale
Standard Deviation 10.94
|
|
Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy)
35 Gy (up to 12 weeks)
|
31.1 score on a scale
Standard Deviation 12.56
|
30.1 score on a scale
Standard Deviation 16.63
|
34.0 score on a scale
Standard Deviation 9.59
|
31.2 score on a scale
Standard Deviation 13.56
|
|
Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy)
45 Gy (up to 12 weeks)
|
30.3 score on a scale
Standard Deviation 11.42
|
28.9 score on a scale
Standard Deviation 15.61
|
31.2 score on a scale
Standard Deviation 12.33
|
30.4 score on a scale
Standard Deviation 11.65
|
|
Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy)
55 Gy (up to 12 weeks)
|
29.9 score on a scale
Standard Deviation 12.95
|
20.8 score on a scale
Standard Deviation 14.70
|
28.0 score on a scale
Standard Deviation 12.95
|
26.8 score on a scale
Standard Deviation 13.71
|
|
Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy)
65 Gy (up to 12 weeks)
|
29.6 score on a scale
Standard Deviation 10.81
|
26.8 score on a scale
Standard Deviation 18.71
|
27.3 score on a scale
Standard Deviation 9.65
|
29.5 score on a scale
Standard Deviation 12.40
|
SECONDARY outcome
Timeframe: Baseline and up to 12 weeksPopulation: SP. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group for analysis of this endpoint.
The level of C-reactive protein (CRP), which can be measured in your blood, increases when there's inflammation in your body.
Outcome measures
| Measure |
Placebo
n=23 Participants
0.9% saline administered as two intravenous infusions (IV) 3 weeks apart
|
ALD518 (160 mg)
n=32 Participants
ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment or ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg)
n=21 Participants
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg, R)
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
|---|---|---|---|---|
|
Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks
Week 1
|
3.50 mg/L
Interval 3.5 to 3.5
|
-2.20 mg/L
Interval -2.4 to -2.1
|
-1.15 mg/L
Interval -1.7 to -0.6
|
—
|
|
Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks
Week 2
|
8.39 mg/L
Interval -13.1 to 73.1
|
-6.52 mg/L
Interval -31.8 to -0.1
|
-14.74 mg/L
Interval -75.6 to -0.2
|
—
|
|
Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks
Week 3
|
12.35 mg/L
Interval 0.8 to 23.9
|
-1.75 mg/L
Interval -2.3 to -0.4
|
-14.78 mg/L
Interval -29.2 to -0.6
|
—
|
|
Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks
Week 4
|
4.71 mg/L
Interval -12.6 to 38.1
|
-6.82 mg/L
Interval -31.8 to -0.1
|
-14.63 mg/L
Interval -75.7 to -0.2
|
—
|
|
Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks
Week 5
|
27.85 mg/L
Interval 8.6 to 47.1
|
-15.50 mg/L
Interval -42.2 to -1.9
|
-6.30 mg/L
Interval -27.7 to -0.6
|
—
|
|
Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks
Week 6
|
20.52 mg/L
Interval -9.5 to 98.2
|
-6.93 mg/L
Interval -31.8 to 0.7
|
-11.92 mg/L
Interval -75.7 to -0.9
|
—
|
|
Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks
Week 8 (last day of RT)
|
6.51 mg/L
Interval -5.3 to 58.8
|
-7.84 mg/L
Interval -42.8 to -0.1
|
-13.96 mg/L
Interval -75.7 to -0.2
|
—
|
|
Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks
Week 12 (4 weeks post RT)
|
2.99 mg/L
Interval -12.6 to 51.2
|
-8.16 mg/L
Interval -42.9 to -0.1
|
-14.53 mg/L
Interval -75.7 to -0.2
|
—
|
Adverse Events
Placebo
Serious events: 7 serious events
Other events: 22 other events
Deaths: 0 deaths
ALD518 (160 mg)
Serious events: 15 serious events
Other events: 32 other events
Deaths: 4 deaths
ALD518 (320 mg)
Serious events: 8 serious events
Other events: 21 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Placebo
n=23 participants at risk
0.9% saline administered as two intravenous infusions (IV) 3 weeks apart
|
ALD518 (160 mg)
n=32 participants at risk
ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment or ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg)
n=21 participants at risk
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Ear and labyrinth disorders
Tinnitis
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Dysphagia
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.4%
3/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Oral pain
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
6.2%
2/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Tongue haemorrhage
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
General disorders
General physical health deterioration
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.4%
3/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
General disorders
Pyrexia
|
8.7%
2/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Injury, poisoning and procedural complications
Tracheostomy malfunction
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Blood phosphorous decreased
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Electrocardiogram ST segment depression
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Troponin increased
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.7%
2/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airway disorder
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal fistula
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
Other adverse events
| Measure |
Placebo
n=23 participants at risk
0.9% saline administered as two intravenous infusions (IV) 3 weeks apart
|
ALD518 (160 mg)
n=32 participants at risk
ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment or ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
ALD518 (320 mg)
n=21 participants at risk
ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
17.4%
4/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
25.0%
8/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
28.6%
6/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
17.4%
4/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
12.5%
4/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Blood and lymphatic system disorders
Anaemia
|
17.4%
4/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
31.2%
10/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
19.0%
4/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Blood and lymphatic system disorders
Erythropenia
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Blood and lymphatic system disorders
Leukopenia
|
30.4%
7/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
40.6%
13/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
28.6%
6/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Blood and lymphatic system disorders
Lymphatic obstruction
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
8.7%
2/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.4%
3/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.5%
2/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.0%
3/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
31.2%
10/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
23.8%
5/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.7%
2/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
28.1%
9/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
33.3%
7/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Ear and labyrinth disorders
Deafness
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Ear and labyrinth disorders
Ear discomfort
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Ear and labyrinth disorders
Ear pain
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
15.6%
5/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
14.3%
3/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Ear and labyrinth disorders
Hypoacusis
|
8.7%
2/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
6.2%
2/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Ear and labyrinth disorders
Tinnitis
|
17.4%
4/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
6.2%
2/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.5%
2/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Ear and labyrinth disorders
Vertigo
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.4%
3/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.7%
2/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
6.2%
2/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Aphagia
|
8.7%
2/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Breath odor
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.5%
2/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Constipation
|
56.5%
13/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
68.8%
22/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
42.9%
9/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Diarrhoea
|
43.5%
10/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
21.9%
7/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
14.3%
3/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Dry mouth
|
43.5%
10/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
34.4%
11/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
23.8%
5/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Dyspepsia
|
13.0%
3/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
12.5%
4/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Dysphagia
|
26.1%
6/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
37.5%
12/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.5%
2/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
15.6%
5/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.5%
2/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
14.3%
3/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.5%
2/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Nausea
|
60.9%
14/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
62.5%
20/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
66.7%
14/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Odynophagia
|
21.7%
5/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
15.6%
5/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
19.0%
4/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Oral pain
|
39.1%
9/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.4%
3/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
33.3%
7/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Saliva altered
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
6.2%
2/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.5%
2/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.5%
2/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Stomatitis
|
8.7%
2/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Swollen tongue
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Tongue oedema
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.5%
2/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Gastrointestinal disorders
Vomiting
|
39.1%
9/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
37.5%
12/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
47.6%
10/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
General disorders
Asthenia
|
13.0%
3/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
12.5%
4/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
19.0%
4/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
General disorders
Catheter site inflammation
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
General disorders
Catheter site oedema
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
General disorders
Catheter site pain
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.5%
2/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
General disorders
Drug intolerance
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
General disorders
Face oedema
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
General disorders
Fatigue
|
34.8%
8/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
21.9%
7/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
23.8%
5/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
General disorders
Hyperthermia
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
General disorders
Infusion site erythema
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
General disorders
Local swelling
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
General disorders
Localized oedema
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
General disorders
Malaise
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
General disorders
Oedema peripheral
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
General disorders
Pyrexia
|
8.7%
2/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Bronchitis
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Febrile infection
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Herpes simplex
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Infective glossitis
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Lower respiratory tract infection
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Lower respiratory tract infection fungal
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Nasopharyngitis
|
17.4%
4/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
14.3%
3/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Oral candidiasis
|
47.8%
11/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
56.2%
18/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
38.1%
8/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
6.2%
2/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Post procedural cellulitis
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Postoperative wound infection
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Pseudomonas infection
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Staphylococcal pharyngitis
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Tracheostomy infection
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.7%
2/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
6.2%
2/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Viral infection
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Injury, poisoning and procedural complications
Post procedural oedema
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Injury, poisoning and procedural complications
Radiation fibrosis
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
30.4%
7/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
25.0%
8/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
23.8%
5/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Alanine aminotransferase increased
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
12.5%
4/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Aspartate aminotransferase increased
|
8.7%
2/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
6.2%
2/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
14.3%
3/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Blood alkaline phosphotase increased
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Blood calcium decreased
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Blood chloride decreased
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.4%
3/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Blood creatinine increased
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
15.6%
5/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Blood glucose increased
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Blood potassium decreased
|
8.7%
2/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Blood pressure increased
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
6.2%
2/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Blood urea increased
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
C-reactive protein increased
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Creatinine renal clearance decreased
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Electrocardiogram change
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.5%
2/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Globulins decreased
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
6.2%
2/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Haematocrit decreased
|
8.7%
2/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.5%
2/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Haemoglobin decreased
|
8.7%
2/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.4%
3/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.5%
2/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Lymphocyte count decreased
|
8.7%
2/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.5%
2/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Mean cell haemoglobin concentration decreased
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Mean cell haemoglobin decreased
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Mean cell volume decreased
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Neutrophil count decreased
|
8.7%
2/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
6.2%
2/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
28.6%
6/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Platelet count decreased
|
8.7%
2/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
21.9%
7/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
38.1%
8/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Prealbumin decreased
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Renal function test abnormal
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Reticulocyte count decreased
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
Weight decreased
|
30.4%
7/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
34.4%
11/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
52.4%
11/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Investigations
White blood cell count decreased
|
8.7%
2/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.4%
3/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
42.9%
9/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
21.7%
5/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
12.5%
4/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
15.6%
5/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
8.7%
2/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Metabolism and nutrition disorders
Gout
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.7%
2/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
6.2%
2/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
19.0%
4/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
15.6%
5/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
19.0%
4/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
6.2%
2/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.7%
2/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Metabolism and nutrition disorders
Hypophagia
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.7%
2/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
6.2%
2/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour ulceration
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Nervous system disorders
Ageusia
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.4%
3/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.5%
2/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Nervous system disorders
Aphasia
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Nervous system disorders
Aphonia
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Nervous system disorders
Cognitive disorder
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Nervous system disorders
Dizziness
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
21.9%
7/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Nervous system disorders
Drooling
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
6.2%
2/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Nervous system disorders
Dysgeusia
|
52.2%
12/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
34.4%
11/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
23.8%
5/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Nervous system disorders
Headache
|
34.8%
8/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
18.8%
6/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
14.3%
3/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Nervous system disorders
Lethargy
|
8.7%
2/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Nervous system disorders
Polyneuropathy
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Nervous system disorders
Tongue biting
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Nervous system disorders
Tongue paralysis
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Psychiatric disorders
Anxiety
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
12.5%
4/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
19.0%
4/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.5%
2/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Psychiatric disorders
Depressed mood
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Psychiatric disorders
Depression
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Psychiatric disorders
Insomnia
|
17.4%
4/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
18.8%
6/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Renal and urinary disorders
Renal failure
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.7%
2/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.4%
3/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
33.3%
7/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
13.0%
3/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.4%
3/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
14.3%
3/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
6.2%
2/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Epiglottic oedema
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
12.5%
4/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.5%
2/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discolored
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
13.0%
3/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
6.2%
2/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.7%
2/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
6.2%
2/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Skin and subcutaneous tissue disorders
Photodermatosis
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
6.2%
2/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
6.2%
2/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Skin and subcutaneous tissue disorders
Skin discoloration
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Vascular disorders
Aortic dilatation
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Vascular disorders
Hypertension
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
6.2%
2/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Vascular disorders
Hypotension
|
8.7%
2/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
6.2%
2/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
9.5%
2/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Vascular disorders
Lymphoedema
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
3.1%
1/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Vascular disorders
Thrombophlebitis
|
4.3%
1/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/23 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
0.00%
0/32 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
4.8%
1/21 • Up to 15 months for each participant
Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatment they received. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place