Trial Outcomes & Findings for Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV) (NCT NCT00845650)
NCT ID: NCT00845650
Last Updated: 2024-03-18
Results Overview
Any untoward medical occurrence reported to or observed by the principal investigator (PI), including as identified from other safety assessments (eg, vital signs, clinical laboratory testing, electrocardiogram).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
129 participants
Primary outcome timeframe
From the time of infusion through Day 90.
Results posted on
2024-03-18
Participant Flow
Participant milestones
| Measure |
AIGIV 3.5 mg/kg (Cohort A)
AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 90 mg/kg (Cohort A)
Gamunex 90 mg/kg total IgG as a single intravenous infusion.
|
AIGIV 7.0 mg/kg (Cohort B)
AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 180 mg/kg (Cohort B)
Gamunex 180 mg/kg total IgG as a single intravenous infusion.
|
AIGIV 14.0 mg/kg (Cohort C)
AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 360 mg/kg (Cohort C)
Gamunex 360 mg/kg total IgG as a single intravenous infusion.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
5
|
31
|
14
|
31
|
17
|
|
Overall Study
COMPLETED
|
30
|
5
|
28
|
13
|
28
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
3
|
1
|
3
|
2
|
Reasons for withdrawal
| Measure |
AIGIV 3.5 mg/kg (Cohort A)
AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 90 mg/kg (Cohort A)
Gamunex 90 mg/kg total IgG as a single intravenous infusion.
|
AIGIV 7.0 mg/kg (Cohort B)
AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 180 mg/kg (Cohort B)
Gamunex 180 mg/kg total IgG as a single intravenous infusion.
|
AIGIV 14.0 mg/kg (Cohort C)
AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 360 mg/kg (Cohort C)
Gamunex 360 mg/kg total IgG as a single intravenous infusion.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
3
|
1
|
0
|
1
|
|
Overall Study
Sponsor hold on dosing
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Unable to access IV line
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV)
Baseline characteristics by cohort
| Measure |
AIGIV 3.5 mg/kg (Cohort A)
n=31 Participants
AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 90 mg/kg (Cohort A)
n=5 Participants
Gamunex 90 mg/kg total IgG as a single intravenous infusion.
|
AIGIV 7.0 mg/kg (Cohort B)
n=31 Participants
AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 180 mg/kg (Cohort B)
n=14 Participants
Gamunex 180 mg/kg total IgG as a single intravenous infusion.
|
AIGIV 14.0 mg/kg (Cohort C)
n=31 Participants
AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 360 mg/kg (Cohort C)
n=17 Participants
Gamunex 360 mg/kg total IgG as a single intravenous infusion.
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.1 years
STANDARD_DEVIATION 10.3 • n=93 Participants
|
35.2 years
STANDARD_DEVIATION 13.8 • n=4 Participants
|
32.1 years
STANDARD_DEVIATION 10.6 • n=27 Participants
|
37.1 years
STANDARD_DEVIATION 9.4 • n=483 Participants
|
33.3 years
STANDARD_DEVIATION 9.1 • n=36 Participants
|
36.6 years
STANDARD_DEVIATION 9.8 • n=10 Participants
|
34.3 years
STANDARD_DEVIATION 10.0 • n=115 Participants
|
|
Age, Customized
18 to < 30 years
|
12 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
50 Participants
n=115 Participants
|
|
Age, Customized
30 to < 40 years
|
7 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
8 Participants
n=10 Participants
|
36 Participants
n=115 Participants
|
|
Age, Customized
40 to < 50 years
|
9 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
33 Participants
n=115 Participants
|
|
Age, Customized
≥ 50 years
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
17 Participants
n=36 Participants
|
10 Participants
n=10 Participants
|
57 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
14 Participants
n=36 Participants
|
7 Participants
n=10 Participants
|
72 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
28 Participants
n=36 Participants
|
15 Participants
n=10 Participants
|
121 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
16 Participants
n=36 Participants
|
9 Participants
n=10 Participants
|
76 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
12 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
45 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
|
Body Mass Index
< 25 kg/m^2
|
10 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
7 Participants
n=10 Participants
|
41 Participants
n=115 Participants
|
|
Body Mass Index
≥ 25 kg/m^2
|
21 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
22 Participants
n=36 Participants
|
10 Participants
n=10 Participants
|
88 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: From the time of infusion through Day 90.Population: Safety Population: all subjects who received any infusion of AIGIV or Gamunex.
Any untoward medical occurrence reported to or observed by the principal investigator (PI), including as identified from other safety assessments (eg, vital signs, clinical laboratory testing, electrocardiogram).
Outcome measures
| Measure |
AIGIV 3.5 mg/kg (Cohort A)
n=30 Participants
AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 90 mg/kg (Cohort A)
n=5 Participants
Gamunex 90 mg/kg total IgG as a single intravenous infusion.
|
AIGIV 7.0 mg/kg (Cohort B)
n=31 Participants
AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 180 mg/kg (Cohort B)
n=14 Participants
Gamunex 180 mg/kg total IgG as a single intravenous infusion.
|
AIGIV 14.0 mg/kg (Cohort C)
n=29 Participants
AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 360 mg/kg (Cohort C)
n=16 Participants
Gamunex 360 mg/kg total IgG as a single intravenous infusion.
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Adverse Events (AEs)
|
28 Participants
|
5 Participants
|
29 Participants
|
11 Participants
|
29 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: From the time of infusion through Day 90 postinfusion.Population: Pharmacokinetic (PK) intent-to-treat (ITT) population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.
Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion. Assay results are reported as the 50% neutralization factor, TNA NF50: the ED50 of the test sample (ie, effective dilution of test sample that neutralized 50% of toxin) divided by the ED50 of the reference standard.
Outcome measures
| Measure |
AIGIV 3.5 mg/kg (Cohort A)
n=27 Participants
AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 90 mg/kg (Cohort A)
n=28 Participants
Gamunex 90 mg/kg total IgG as a single intravenous infusion.
|
AIGIV 7.0 mg/kg (Cohort B)
n=28 Participants
AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 180 mg/kg (Cohort B)
Gamunex 180 mg/kg total IgG as a single intravenous infusion.
|
AIGIV 14.0 mg/kg (Cohort C)
AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 360 mg/kg (Cohort C)
Gamunex 360 mg/kg total IgG as a single intravenous infusion.
|
|---|---|---|---|---|---|---|
|
Maximum Plasma Titer/Concentration of TNA (Toxin Neutralizing Antibody) (Cmax)
|
1.07 NF50 (50% neutralization factor)
Standard Deviation 0.26
|
2.21 NF50 (50% neutralization factor)
Standard Deviation 0.48
|
4.31 NF50 (50% neutralization factor)
Standard Deviation 0.98
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the time of infusion through Day 90 postinfusion.Population: Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.
Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.
Outcome measures
| Measure |
AIGIV 3.5 mg/kg (Cohort A)
n=27 Participants
AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 90 mg/kg (Cohort A)
n=28 Participants
Gamunex 90 mg/kg total IgG as a single intravenous infusion.
|
AIGIV 7.0 mg/kg (Cohort B)
n=28 Participants
AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 180 mg/kg (Cohort B)
Gamunex 180 mg/kg total IgG as a single intravenous infusion.
|
AIGIV 14.0 mg/kg (Cohort C)
AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 360 mg/kg (Cohort C)
Gamunex 360 mg/kg total IgG as a single intravenous infusion.
|
|---|---|---|---|---|---|---|
|
Time of Cmax
|
4.49 hours
Standard Deviation 13.65
|
7.81 hours
Standard Deviation 23.06
|
7.35 hours
Standard Deviation 22.53
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the time of infusion through Day 90 postinfusion.Population: Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.
Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.
Outcome measures
| Measure |
AIGIV 3.5 mg/kg (Cohort A)
n=27 Participants
AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 90 mg/kg (Cohort A)
n=28 Participants
Gamunex 90 mg/kg total IgG as a single intravenous infusion.
|
AIGIV 7.0 mg/kg (Cohort B)
n=28 Participants
AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 180 mg/kg (Cohort B)
Gamunex 180 mg/kg total IgG as a single intravenous infusion.
|
AIGIV 14.0 mg/kg (Cohort C)
AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 360 mg/kg (Cohort C)
Gamunex 360 mg/kg total IgG as a single intravenous infusion.
|
|---|---|---|---|---|---|---|
|
Area Under the Curve to the Last Time With a Measurable TNA Titer (AUC[0-t])
|
323.03 h*NF50
Standard Deviation 312.94
|
636.31 h*NF50
Standard Deviation 115.17
|
1277.30 h*NF50
Standard Deviation 186.41
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the time of infusion through Day 90 postinfusion.Population: Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.
Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.
Outcome measures
| Measure |
AIGIV 3.5 mg/kg (Cohort A)
n=26 Participants
AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 90 mg/kg (Cohort A)
n=23 Participants
Gamunex 90 mg/kg total IgG as a single intravenous infusion.
|
AIGIV 7.0 mg/kg (Cohort B)
n=25 Participants
AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 180 mg/kg (Cohort B)
Gamunex 180 mg/kg total IgG as a single intravenous infusion.
|
AIGIV 14.0 mg/kg (Cohort C)
AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 360 mg/kg (Cohort C)
Gamunex 360 mg/kg total IgG as a single intravenous infusion.
|
|---|---|---|---|---|---|---|
|
Area Under the Curve to Infinity (AUC[0-inf])
|
329.01 h*NF50
Standard Deviation 51.04
|
698.26 h*NF50
Standard Deviation 117.61
|
1401.08 h*NF50
Standard Deviation 216.62
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the time of infusion through Day 90 postinfusion.Population: Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.
Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.
Outcome measures
| Measure |
AIGIV 3.5 mg/kg (Cohort A)
n=26 Participants
AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 90 mg/kg (Cohort A)
n=23 Participants
Gamunex 90 mg/kg total IgG as a single intravenous infusion.
|
AIGIV 7.0 mg/kg (Cohort B)
n=25 Participants
AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 180 mg/kg (Cohort B)
Gamunex 180 mg/kg total IgG as a single intravenous infusion.
|
AIGIV 14.0 mg/kg (Cohort C)
AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 360 mg/kg (Cohort C)
Gamunex 360 mg/kg total IgG as a single intravenous infusion.
|
|---|---|---|---|---|---|---|
|
Elimination Rate Constant
|
0.0014 /h
Standard Deviation 0.0004
|
0.0013 /h
Standard Deviation 0.0003
|
0.0012 /h
Standard Deviation 0.0004
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the time of infusion through Day 90 postinfusion.Population: Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.
Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.
Outcome measures
| Measure |
AIGIV 3.5 mg/kg (Cohort A)
n=26 Participants
AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 90 mg/kg (Cohort A)
n=23 Participants
Gamunex 90 mg/kg total IgG as a single intravenous infusion.
|
AIGIV 7.0 mg/kg (Cohort B)
n=25 Participants
AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 180 mg/kg (Cohort B)
Gamunex 180 mg/kg total IgG as a single intravenous infusion.
|
AIGIV 14.0 mg/kg (Cohort C)
AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 360 mg/kg (Cohort C)
Gamunex 360 mg/kg total IgG as a single intravenous infusion.
|
|---|---|---|---|---|---|---|
|
Elimination Half-life (t½)
|
489.36 hours
Interval 301.12 to 1003.89
|
526.36 hours
Interval 361.11 to 870.84
|
569.98 hours
Interval 274.82 to 1100.34
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the time of infusion through Day 90 postinfusion.Population: Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.
Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.
Outcome measures
| Measure |
AIGIV 3.5 mg/kg (Cohort A)
n=26 Participants
AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 90 mg/kg (Cohort A)
n=23 Participants
Gamunex 90 mg/kg total IgG as a single intravenous infusion.
|
AIGIV 7.0 mg/kg (Cohort B)
n=25 Participants
AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 180 mg/kg (Cohort B)
Gamunex 180 mg/kg total IgG as a single intravenous infusion.
|
AIGIV 14.0 mg/kg (Cohort C)
AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 360 mg/kg (Cohort C)
Gamunex 360 mg/kg total IgG as a single intravenous infusion.
|
|---|---|---|---|---|---|---|
|
Mean Residence Time (MRT)
|
679.67 hours
Standard Deviation 178.07
|
694.68 hours
Standard Deviation 184.39
|
724.82 hours
Standard Deviation 175.58
|
—
|
—
|
—
|
Adverse Events
AIGIV 3.5 mg/kg (Cohort A)
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Gamunex 90 mg/kg (Cohort A)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
AIGIV 7.0 mg/kg (Cohort B)
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Gamunex 180 mg/kg (Cohort B)
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
AIGIV 14.0 mg/kg (Cohort C)
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Gamunex 360 mg/kg (Cohort C)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AIGIV 3.5 mg/kg (Cohort A)
n=30 participants at risk
AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 90 mg/kg (Cohort A)
n=5 participants at risk
Gamunex 90 mg/kg total IgG as a single intravenous infusion.
|
AIGIV 7.0 mg/kg (Cohort B)
n=31 participants at risk
AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 180 mg/kg (Cohort B)
n=14 participants at risk
Gamunex 180 mg/kg total IgG as a single intravenous infusion.
|
AIGIV 14.0 mg/kg (Cohort C)
n=29 participants at risk
AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 360 mg/kg (Cohort C)
n=16 participants at risk
Gamunex 360 mg/kg total IgG as a single intravenous infusion.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30 • Number of events 2 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
0.00%
0/16 • From the time of infusion through Day 90.
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
7.1%
1/14 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
0.00%
0/16 • From the time of infusion through Day 90.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
7.1%
1/14 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
0.00%
0/16 • From the time of infusion through Day 90.
|
|
Pregnancy, puerperium and perinatal conditions
Intra-uterine death
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
3.2%
1/31 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
0.00%
0/16 • From the time of infusion through Day 90.
|
Other adverse events
| Measure |
AIGIV 3.5 mg/kg (Cohort A)
n=30 participants at risk
AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 90 mg/kg (Cohort A)
n=5 participants at risk
Gamunex 90 mg/kg total IgG as a single intravenous infusion.
|
AIGIV 7.0 mg/kg (Cohort B)
n=31 participants at risk
AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 180 mg/kg (Cohort B)
n=14 participants at risk
Gamunex 180 mg/kg total IgG as a single intravenous infusion.
|
AIGIV 14.0 mg/kg (Cohort C)
n=29 participants at risk
AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
|
Gamunex 360 mg/kg (Cohort C)
n=16 participants at risk
Gamunex 360 mg/kg total IgG as a single intravenous infusion.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/30 • From the time of infusion through Day 90.
|
20.0%
1/5 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
0.00%
0/16 • From the time of infusion through Day 90.
|
|
Blood and lymphatic system disorders
Neutropenia
|
26.7%
8/30 • Number of events 11 • From the time of infusion through Day 90.
|
20.0%
1/5 • Number of events 1 • From the time of infusion through Day 90.
|
3.2%
1/31 • Number of events 1 • From the time of infusion through Day 90.
|
7.1%
1/14 • Number of events 1 • From the time of infusion through Day 90.
|
3.4%
1/29 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/16 • From the time of infusion through Day 90.
|
|
Cardiac disorders
Bradycardia
|
23.3%
7/30 • Number of events 12 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
9.7%
3/31 • Number of events 3 • From the time of infusion through Day 90.
|
14.3%
2/14 • Number of events 5 • From the time of infusion through Day 90.
|
6.9%
2/29 • Number of events 2 • From the time of infusion through Day 90.
|
0.00%
0/16 • From the time of infusion through Day 90.
|
|
Cardiac disorders
Tachycardia
|
20.0%
6/30 • Number of events 6 • From the time of infusion through Day 90.
|
20.0%
1/5 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
10.3%
3/29 • Number of events 3 • From the time of infusion through Day 90.
|
0.00%
0/16 • From the time of infusion through Day 90.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
6.2%
1/16 • Number of events 1 • From the time of infusion through Day 90.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30 • Number of events 2 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
6.2%
1/16 • Number of events 1 • From the time of infusion through Day 90.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
2/30 • Number of events 2 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
0.00%
0/16 • From the time of infusion through Day 90.
|
|
Gastrointestinal disorders
Nausea
|
3.3%
1/30 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
19.4%
6/31 • Number of events 7 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
6.9%
2/29 • Number of events 2 • From the time of infusion through Day 90.
|
12.5%
2/16 • Number of events 2 • From the time of infusion through Day 90.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
6.2%
1/16 • Number of events 2 • From the time of infusion through Day 90.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
12.9%
4/31 • Number of events 4 • From the time of infusion through Day 90.
|
7.1%
1/14 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
6.2%
1/16 • Number of events 1 • From the time of infusion through Day 90.
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
1/30 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
6.5%
2/31 • Number of events 2 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
6.9%
2/29 • Number of events 2 • From the time of infusion through Day 90.
|
0.00%
0/16 • From the time of infusion through Day 90.
|
|
General disorders
Chills
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
3.2%
1/31 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
6.9%
2/29 • Number of events 2 • From the time of infusion through Day 90.
|
6.2%
1/16 • Number of events 1 • From the time of infusion through Day 90.
|
|
General disorders
Infusion site pain
|
6.7%
2/30 • Number of events 2 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
3.4%
1/29 • Number of events 1 • From the time of infusion through Day 90.
|
6.2%
1/16 • Number of events 1 • From the time of infusion through Day 90.
|
|
General disorders
Infusion site reaction
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
3.4%
1/29 • Number of events 1 • From the time of infusion through Day 90.
|
6.2%
1/16 • Number of events 2 • From the time of infusion through Day 90.
|
|
General disorders
Pain
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
7.1%
1/14 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
0.00%
0/16 • From the time of infusion through Day 90.
|
|
General disorders
Pyrexia
|
3.3%
1/30 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
6.5%
2/31 • Number of events 2 • From the time of infusion through Day 90.
|
7.1%
1/14 • Number of events 1 • From the time of infusion through Day 90.
|
3.4%
1/29 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/16 • From the time of infusion through Day 90.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
9.7%
3/31 • Number of events 3 • From the time of infusion through Day 90.
|
7.1%
1/14 • Number of events 1 • From the time of infusion through Day 90.
|
20.7%
6/29 • Number of events 7 • From the time of infusion through Day 90.
|
31.2%
5/16 • Number of events 5 • From the time of infusion through Day 90.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
6.5%
2/31 • Number of events 2 • From the time of infusion through Day 90.
|
7.1%
1/14 • Number of events 1 • From the time of infusion through Day 90.
|
3.4%
1/29 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/16 • From the time of infusion through Day 90.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
6.9%
2/29 • Number of events 2 • From the time of infusion through Day 90.
|
0.00%
0/16 • From the time of infusion through Day 90.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
7.1%
1/14 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
0.00%
0/16 • From the time of infusion through Day 90.
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
2/30 • Number of events 2 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
6.5%
2/31 • Number of events 2 • From the time of infusion through Day 90.
|
7.1%
1/14 • Number of events 1 • From the time of infusion through Day 90.
|
6.9%
2/29 • Number of events 2 • From the time of infusion through Day 90.
|
6.2%
1/16 • Number of events 1 • From the time of infusion through Day 90.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
6.2%
1/16 • Number of events 1 • From the time of infusion through Day 90.
|
|
Infections and infestations
Urinary tract infection
|
3.3%
1/30 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
3.2%
1/31 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
6.2%
1/16 • Number of events 1 • From the time of infusion through Day 90.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/30 • From the time of infusion through Day 90.
|
20.0%
1/5 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
0.00%
0/16 • From the time of infusion through Day 90.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
3.2%
1/31 • Number of events 2 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
3.4%
1/29 • Number of events 2 • From the time of infusion through Day 90.
|
12.5%
2/16 • Number of events 2 • From the time of infusion through Day 90.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
3.2%
1/31 • Number of events 2 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
3.4%
1/29 • Number of events 3 • From the time of infusion through Day 90.
|
6.2%
1/16 • Number of events 1 • From the time of infusion through Day 90.
|
|
Investigations
Bacteria urine
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
6.2%
1/16 • Number of events 1 • From the time of infusion through Day 90.
|
|
Investigations
Blood pressure decreased
|
3.3%
1/30 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
12.5%
2/16 • Number of events 3 • From the time of infusion through Day 90.
|
|
Investigations
Blood pressure increased
|
56.7%
17/30 • Number of events 47 • From the time of infusion through Day 90.
|
60.0%
3/5 • Number of events 5 • From the time of infusion through Day 90.
|
64.5%
20/31 • Number of events 46 • From the time of infusion through Day 90.
|
35.7%
5/14 • Number of events 5 • From the time of infusion through Day 90.
|
65.5%
19/29 • Number of events 37 • From the time of infusion through Day 90.
|
43.8%
7/16 • Number of events 12 • From the time of infusion through Day 90.
|
|
Investigations
Blood urine present
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
3.2%
1/31 • Number of events 1 • From the time of infusion through Day 90.
|
7.1%
1/14 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
6.2%
1/16 • Number of events 1 • From the time of infusion through Day 90.
|
|
Investigations
Body temperature increased
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
3.2%
1/31 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
10.3%
3/29 • Number of events 6 • From the time of infusion through Day 90.
|
0.00%
0/16 • From the time of infusion through Day 90.
|
|
Investigations
Heart rate decreased
|
3.3%
1/30 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
6.5%
2/31 • Number of events 2 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
24.1%
7/29 • Number of events 10 • From the time of infusion through Day 90.
|
12.5%
2/16 • Number of events 2 • From the time of infusion through Day 90.
|
|
Investigations
Heart rate increased
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
22.6%
7/31 • Number of events 7 • From the time of infusion through Day 90.
|
7.1%
1/14 • Number of events 1 • From the time of infusion through Day 90.
|
13.8%
4/29 • Number of events 4 • From the time of infusion through Day 90.
|
18.8%
3/16 • Number of events 3 • From the time of infusion through Day 90.
|
|
Investigations
Nitrite urine
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
6.2%
1/16 • Number of events 1 • From the time of infusion through Day 90.
|
|
Investigations
Protein urine
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
3.4%
1/29 • Number of events 1 • From the time of infusion through Day 90.
|
6.2%
1/16 • Number of events 1 • From the time of infusion through Day 90.
|
|
Investigations
Respiratory rate increased
|
33.3%
10/30 • Number of events 14 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
19.4%
6/31 • Number of events 7 • From the time of infusion through Day 90.
|
42.9%
6/14 • Number of events 7 • From the time of infusion through Day 90.
|
62.1%
18/29 • Number of events 20 • From the time of infusion through Day 90.
|
50.0%
8/16 • Number of events 8 • From the time of infusion through Day 90.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
6.9%
2/29 • Number of events 2 • From the time of infusion through Day 90.
|
0.00%
0/16 • From the time of infusion through Day 90.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
7.1%
1/14 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
0.00%
0/16 • From the time of infusion through Day 90.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
9.7%
3/31 • Number of events 4 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
6.9%
2/29 • Number of events 2 • From the time of infusion through Day 90.
|
0.00%
0/16 • From the time of infusion through Day 90.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
3.4%
1/29 • Number of events 1 • From the time of infusion through Day 90.
|
6.2%
1/16 • Number of events 1 • From the time of infusion through Day 90.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
3.2%
1/31 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
3.4%
1/29 • Number of events 1 • From the time of infusion through Day 90.
|
6.2%
1/16 • Number of events 1 • From the time of infusion through Day 90.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
3.2%
1/31 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
3.4%
1/29 • Number of events 1 • From the time of infusion through Day 90.
|
6.2%
1/16 • Number of events 1 • From the time of infusion through Day 90.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
7.1%
1/14 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
0.00%
0/16 • From the time of infusion through Day 90.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
7.1%
1/14 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
0.00%
0/16 • From the time of infusion through Day 90.
|
|
Nervous system disorders
Dizziness
|
6.7%
2/30 • Number of events 2 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
16.1%
5/31 • Number of events 5 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
12.5%
2/16 • Number of events 2 • From the time of infusion through Day 90.
|
|
Nervous system disorders
Headache
|
16.7%
5/30 • Number of events 7 • From the time of infusion through Day 90.
|
40.0%
2/5 • Number of events 2 • From the time of infusion through Day 90.
|
32.3%
10/31 • Number of events 10 • From the time of infusion through Day 90.
|
21.4%
3/14 • Number of events 5 • From the time of infusion through Day 90.
|
34.5%
10/29 • Number of events 12 • From the time of infusion through Day 90.
|
18.8%
3/16 • Number of events 4 • From the time of infusion through Day 90.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
6.2%
1/16 • Number of events 1 • From the time of infusion through Day 90.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
6.2%
1/16 • Number of events 1 • From the time of infusion through Day 90.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
10.3%
3/29 • Number of events 7 • From the time of infusion through Day 90.
|
0.00%
0/16 • From the time of infusion through Day 90.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
6.5%
2/31 • Number of events 2 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
0.00%
0/16 • From the time of infusion through Day 90.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
1/30 • Number of events 1 • From the time of infusion through Day 90.
|
20.0%
1/5 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
6.2%
1/16 • Number of events 2 • From the time of infusion through Day 90.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.3%
1/30 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
6.5%
2/31 • Number of events 2 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
3.4%
1/29 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/16 • From the time of infusion through Day 90.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
3.3%
1/30 • Number of events 1 • From the time of infusion through Day 90.
|
20.0%
1/5 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
3.4%
1/29 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/16 • From the time of infusion through Day 90.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
6.2%
1/16 • Number of events 1 • From the time of infusion through Day 90.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
0.00%
0/14 • From the time of infusion through Day 90.
|
3.4%
1/29 • Number of events 1 • From the time of infusion through Day 90.
|
18.8%
3/16 • Number of events 3 • From the time of infusion through Day 90.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/30 • From the time of infusion through Day 90.
|
0.00%
0/5 • From the time of infusion through Day 90.
|
0.00%
0/31 • From the time of infusion through Day 90.
|
7.1%
1/14 • Number of events 1 • From the time of infusion through Day 90.
|
0.00%
0/29 • From the time of infusion through Day 90.
|
0.00%
0/16 • From the time of infusion through Day 90.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place