Trial Outcomes & Findings for A Study of TAK-881 in Healthy Adults (NCT NCT05059977)
NCT ID: NCT05059977
Last Updated: 2024-01-12
Results Overview
A tolerability event was considered to have occurred if an infusion was tolerable. An infusion was considered tolerable if the infusion rate was not reduced or the infusion was not interrupted or stopped, due to any treatment-emergent adverse event (TEAE) related to TAK-881. Number of participants with tolerability events related to infusion of TAK-881 per infusion sites (1 and 2) were reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Up to Day 4
Results posted on
2024-01-12
Participant Flow
This study was conducted at single center in the United States from 12 October 2021 to 12 April 2022.
A total of 24 participants were enrolled and received the study treatment in this study.
Participant milestones
| Measure |
TAK-881 0.4 g/kg Warmed
Participants received a single dose of TAK-881 comprised of 0.4 gram per kilogram (g/kg) (in-line warmed) Immune Globulin Subcutaneous (IGSC), 20 percent (%) at progressively increased infusion rates and a Recombinant Human Hyaluronidase (rHuPH20) dose of 80 unit per gram (U/g) immunoglobulin G (IgG) on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
TAK-881 1.0 g/kg Warmed
Participants received a single dose of TAK-881 comprised of 1.0 g/kg (in-line warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
TAK-881 1.0 g/kg Un-warmed
Participants received a single dose of TAK-881 comprised of 1.0 g/kg (un-warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
TAK-881 0.4 g/kg Warmed
Participants received a single dose of TAK-881 comprised of 0.4 gram per kilogram (g/kg) (in-line warmed) Immune Globulin Subcutaneous (IGSC), 20 percent (%) at progressively increased infusion rates and a Recombinant Human Hyaluronidase (rHuPH20) dose of 80 unit per gram (U/g) immunoglobulin G (IgG) on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
TAK-881 1.0 g/kg Warmed
Participants received a single dose of TAK-881 comprised of 1.0 g/kg (in-line warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
TAK-881 1.0 g/kg Un-warmed
Participants received a single dose of TAK-881 comprised of 1.0 g/kg (un-warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
A Study of TAK-881 in Healthy Adults
Baseline characteristics by cohort
| Measure |
TAK-881 0.4 g/kg Warmed
n=8 Participants
Participants received a single dose of TAK-881 comprised of 0.4 g/kg (in-line warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
TAK-881 1.0 g/kg Warmed
n=8 Participants
Participants received a single dose of TAK-881 comprised of 1.0 g/kg (in-line warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
TAK-881 1.0 g/kg Un-warmed
n=8 Participants
Participants received a single dose of TAK-881 comprised of 1.0 g/kg (un-warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.6 years
STANDARD_DEVIATION 4.57 • n=5 Participants
|
39.4 years
STANDARD_DEVIATION 4.10 • n=7 Participants
|
34.9 years
STANDARD_DEVIATION 10.12 • n=5 Participants
|
39.0 years
STANDARD_DEVIATION 7.29 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to Day 4Population: Safety set included all participants who received a partial or a full dose of TAK-881. Here, "number analyzed" signifies those participants who were evaluable for given categories of this outcome measure.
A tolerability event was considered to have occurred if an infusion was tolerable. An infusion was considered tolerable if the infusion rate was not reduced or the infusion was not interrupted or stopped, due to any treatment-emergent adverse event (TEAE) related to TAK-881. Number of participants with tolerability events related to infusion of TAK-881 per infusion sites (1 and 2) were reported.
Outcome measures
| Measure |
TAK-881 0.4 g/kg Warmed
n=8 Participants
Participants received a single dose of TAK-881 comprised of 0.4 g/kg (in-line warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
TAK-881 1.0 g/kg Warmed
n=8 Participants
Participants received a single dose of TAK-881 comprised of 1.0 g/kg (in-line warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
TAK-881 1.0 g/kg Un-warmed
n=8 Participants
Participants received a single dose of TAK-881 comprised of 1.0 g/kg (un-warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
|---|---|---|---|
|
Number of Participants With Tolerability Events Related to Infusion of TAK-881 Per Infusion Site
Infusion Site 1
|
8 Participants
|
8 Participants
|
8 Participants
|
|
Number of Participants With Tolerability Events Related to Infusion of TAK-881 Per Infusion Site
Infusion Site 2
|
—
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: From the start of study drug administration up to Week 13Population: Safety set included all participants who received a partial or a full dose of TAK-881.
A TEAE was defined as any event emerged or manifested at or after the initiation of treatment with an Investigational product (IP) or medicinal product or any existing event that worsened in either intensity or frequency following exposure to the IP or medicinal product. Any clinically significant treatment-emergent changes in clinical laboratory measurements and vital signs were recorded as TEAEs. Number of participants with TEAEs were reported.
Outcome measures
| Measure |
TAK-881 0.4 g/kg Warmed
n=8 Participants
Participants received a single dose of TAK-881 comprised of 0.4 g/kg (in-line warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
TAK-881 1.0 g/kg Warmed
n=8 Participants
Participants received a single dose of TAK-881 comprised of 1.0 g/kg (in-line warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
TAK-881 1.0 g/kg Un-warmed
n=8 Participants
Participants received a single dose of TAK-881 comprised of 1.0 g/kg (un-warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
|---|---|---|---|
|
Number of Participants With TEAEs
|
8 Participants
|
8 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 13Population: Safety set included all participants who received a partial or a full dose of TAK-881. Here, "number analyzed" signifies those participants who were evaluable for specified categories of this outcome measure.
Positive binding ADA was defined as titer greater than or equal to (\>=) 1:160. Neutralizing antibodies were only tested if binding ADA titer was \>= 1:160. Number of participants with positive binding ADA and neutralizing antibodies to rHuPH20 were reported.
Outcome measures
| Measure |
TAK-881 0.4 g/kg Warmed
n=8 Participants
Participants received a single dose of TAK-881 comprised of 0.4 g/kg (in-line warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
TAK-881 1.0 g/kg Warmed
n=8 Participants
Participants received a single dose of TAK-881 comprised of 1.0 g/kg (in-line warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
TAK-881 1.0 g/kg Un-warmed
n=8 Participants
Participants received a single dose of TAK-881 comprised of 1.0 g/kg (un-warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
|---|---|---|---|
|
Number of Participants With Positive Binding Anti-Drug Antibodies (ADA) and Neutralizing Antibodies to rHuPH20
Binding Antibodies
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 4Population: Safety set included all participants who received a partial or a full dose of TAK-881. Here, "number analyzed" signifies those participants who were evaluable for specified categories of this outcome measure.
The maximum tolerable infusion rate achieved referred to the administration of IGSC, 20% at progressively increasing infusion rates and was defined as the highest infusion rate achieved at which the infusion was tolerable (i.e., no stopping, interruption, or infusion rate reduction due to a TAK-881-related TEAE). The maximum tolerable infusion rate for Infusion Site 2 depended on the planned volume according to the stepwise infusion rate escalation regimen. Number of participants who achieved maximum tolerable infusion rate per infusion sites (1 and 2) for each infusion rate (30, 60, 120, 180, and 300 milliliter per hour \[mL/hour\]) were reported.
Outcome measures
| Measure |
TAK-881 0.4 g/kg Warmed
n=8 Participants
Participants received a single dose of TAK-881 comprised of 0.4 g/kg (in-line warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
TAK-881 1.0 g/kg Warmed
n=8 Participants
Participants received a single dose of TAK-881 comprised of 1.0 g/kg (in-line warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
TAK-881 1.0 g/kg Un-warmed
n=8 Participants
Participants received a single dose of TAK-881 comprised of 1.0 g/kg (un-warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
|---|---|---|---|
|
Number of Participants Who Achieved Maximum Tolerable Infusion Rate Per Infusion Site
Infusion Site 1: 30 mL/hour
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Achieved Maximum Tolerable Infusion Rate Per Infusion Site
Infusion Site 1: 60 mL/hour
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Achieved Maximum Tolerable Infusion Rate Per Infusion Site
Infusion Site 1: 120 mL/hour
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Achieved Maximum Tolerable Infusion Rate Per Infusion Site
Infusion Site 1: 180 mL/hour
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Achieved Maximum Tolerable Infusion Rate Per Infusion Site
Infusion Site 1: 300 mL/hour
|
8 Participants
|
8 Participants
|
8 Participants
|
|
Number of Participants Who Achieved Maximum Tolerable Infusion Rate Per Infusion Site
Infusion Site 2: 30 mL/hour
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Achieved Maximum Tolerable Infusion Rate Per Infusion Site
Infusion Site 2: 60 mL/hour
|
—
|
0 Participants
|
2 Participants
|
|
Number of Participants Who Achieved Maximum Tolerable Infusion Rate Per Infusion Site
Infusion Site 2: 120 mL/hour
|
—
|
0 Participants
|
1 Participants
|
|
Number of Participants Who Achieved Maximum Tolerable Infusion Rate Per Infusion Site
Infusion Site 2: 180 mL/hour
|
—
|
1 Participants
|
1 Participants
|
|
Number of Participants Who Achieved Maximum Tolerable Infusion Rate Per Infusion Site
Infusion Site 2: 300 mL/hour
|
—
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: At Day 1Population: Safety set included all participants who received a partial or a full dose of TAK-881. Here, "number analyzed" signifies those participants who were evaluable for specified categories of this outcome measure.
Total volume infused per infusion sites (1 and 2) for rHuPH20 and IGSC were reported.
Outcome measures
| Measure |
TAK-881 0.4 g/kg Warmed
n=8 Participants
Participants received a single dose of TAK-881 comprised of 0.4 g/kg (in-line warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
TAK-881 1.0 g/kg Warmed
n=8 Participants
Participants received a single dose of TAK-881 comprised of 1.0 g/kg (in-line warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
TAK-881 1.0 g/kg Un-warmed
n=8 Participants
Participants received a single dose of TAK-881 comprised of 1.0 g/kg (un-warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
|---|---|---|---|
|
Total Volume Infused Per Infusion Site for rHuPH20 and IGSC
rHuPH20: Infusion Site 1
|
14.3 milliliter (mL)
Standard Deviation 1.28
|
29.3 milliliter (mL)
Standard Deviation 1.39
|
29.4 milliliter (mL)
Standard Deviation 1.77
|
|
Total Volume Infused Per Infusion Site for rHuPH20 and IGSC
rHuPH20: Infusion Site 2
|
—
|
10.0 milliliter (mL)
Standard Deviation 5.16
|
7.3 milliliter (mL)
Standard Deviation 6.16
|
|
Total Volume Infused Per Infusion Site for rHuPH20 and IGSC
IGSC 20%: Infusion Site 1
|
141.3 milliliter (mL)
Standard Deviation 13.30
|
291.3 milliliter (mL)
Standard Deviation 14.33
|
293.8 milliliter (mL)
Standard Deviation 17.68
|
|
Total Volume Infused Per Infusion Site for rHuPH20 and IGSC
IGSC 20%: Infusion Site 2
|
—
|
97.5 milliliter (mL)
Standard Deviation 51.72
|
70.0 milliliter (mL)
Standard Deviation 61.64
|
SECONDARY outcome
Timeframe: At Day 1Population: Safety set included all participants who received a partial or a full dose of TAK-881. Here, "number analyzed" signifies those participants who were evaluable for specified categories of this outcome measure.
Time to deliver (in minutes) the total infused volume was calculated as (stop date/time of IGSC 20% administration) - (start date/time of rHuPH20 administration). Time to deliver the total infused volume per infusion sites (1 and 2) were reported.
Outcome measures
| Measure |
TAK-881 0.4 g/kg Warmed
n=8 Participants
Participants received a single dose of TAK-881 comprised of 0.4 g/kg (in-line warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
TAK-881 1.0 g/kg Warmed
n=8 Participants
Participants received a single dose of TAK-881 comprised of 1.0 g/kg (in-line warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
TAK-881 1.0 g/kg Un-warmed
n=8 Participants
Participants received a single dose of TAK-881 comprised of 1.0 g/kg (un-warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
|---|---|---|---|
|
Time to Deliver the Total Infused Volume Per Infusion Site
Infusion Site 1
|
63.5 minute
Interval 59.0 to 74.0
|
99.5 minute
Interval 92.0 to 103.0
|
102.0 minute
Interval 91.0 to 112.0
|
|
Time to Deliver the Total Infused Volume Per Infusion Site
Infusion Site 2
|
—
|
53.0 minute
Interval 35.0 to 68.0
|
41.0 minute
Interval 22.0 to 69.0
|
Adverse Events
TAK-881 0.4 g/kg Warmed
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
TAK-881 1.0 g/kg Warmed
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
TAK-881 1.0 g/kg Un-warmed
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TAK-881 0.4 g/kg Warmed
n=8 participants at risk
Participants received a single dose of TAK-881 comprised of 0.4 g/kg (in-line warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
TAK-881 1.0 g/kg Warmed
n=8 participants at risk
Participants received a single dose of TAK-881 comprised of 1.0 g/kg (in-line warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
TAK-881 1.0 g/kg Un-warmed
n=8 participants at risk
Participants received a single dose of TAK-881 comprised of 1.0 g/kg (un-warmed) IGSC, 20% at progressively increased infusion rates and an rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period of 4 days. Participants were followed up to 12 (±1) weeks after the TAK-881 infusion.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • From the start of study drug administration up to Week 13
|
0.00%
0/8 • From the start of study drug administration up to Week 13
|
0.00%
0/8 • From the start of study drug administration up to Week 13
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • From the start of study drug administration up to Week 13
|
0.00%
0/8 • From the start of study drug administration up to Week 13
|
12.5%
1/8 • From the start of study drug administration up to Week 13
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • From the start of study drug administration up to Week 13
|
0.00%
0/8 • From the start of study drug administration up to Week 13
|
12.5%
1/8 • From the start of study drug administration up to Week 13
|
|
General disorders
Infusion site erythema
|
100.0%
8/8 • From the start of study drug administration up to Week 13
|
100.0%
8/8 • From the start of study drug administration up to Week 13
|
100.0%
8/8 • From the start of study drug administration up to Week 13
|
|
General disorders
Infusion site extravasation
|
12.5%
1/8 • From the start of study drug administration up to Week 13
|
0.00%
0/8 • From the start of study drug administration up to Week 13
|
0.00%
0/8 • From the start of study drug administration up to Week 13
|
|
General disorders
Infusion site pain
|
50.0%
4/8 • From the start of study drug administration up to Week 13
|
62.5%
5/8 • From the start of study drug administration up to Week 13
|
50.0%
4/8 • From the start of study drug administration up to Week 13
|
|
General disorders
Infusion site pruritus
|
37.5%
3/8 • From the start of study drug administration up to Week 13
|
62.5%
5/8 • From the start of study drug administration up to Week 13
|
62.5%
5/8 • From the start of study drug administration up to Week 13
|
|
General disorders
Infusion site swelling
|
87.5%
7/8 • From the start of study drug administration up to Week 13
|
100.0%
8/8 • From the start of study drug administration up to Week 13
|
100.0%
8/8 • From the start of study drug administration up to Week 13
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • From the start of study drug administration up to Week 13
|
0.00%
0/8 • From the start of study drug administration up to Week 13
|
0.00%
0/8 • From the start of study drug administration up to Week 13
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER