Trial Outcomes & Findings for Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD (NCT NCT01485796)
NCT ID: NCT01485796
Last Updated: 2021-05-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
54 participants
Primary outcome timeframe
7 months (per subject)
Results posted on
2021-05-19
Participant Flow
Enrollment was conducted at 16 study sites in the US.
Of 54 subjects screened for the study, 37 started treatment. Of the 17 subjects who discontinued the study before treatment, 10 were screen failures, 5 withdrew consent, and for 2 subjects enrollment ended due to other reasons.
Participant milestones
| Measure |
Subcutaneous Treatment With IGI, 10% and rHuPH20
Subcutaneous treatment with IGI, 10% and rHuPH20 occurred in 2 study epochs. In Epoch 1, PIDD patients that were already on intravenous (IV) or subcutaneous (SC) treatment were treated with IGI, 10% and rHuPH20 subcutaneously, with one 1-week dose and interval and one 2-week dose and interval. Epoch 2 was to consist of approx. 6 months (24 weeks) of IGI, 10% and rHuPH20 treatment. For subjects pretreated IV, this treatment was to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), depending on the subject´s previous IV dosing schedule. For subjects pretreated SC, treatment was also to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), at the discretion of the investigator and subject. However, treatment with rHuPH20 was stopped as of August 2012 following a discussion with the FDA, and subjects still active in Epoch 2 were switched to a safety follow-up. During the safety-follow up, subjects received IGI, 10% by either the IV or the SC route.
|
|---|---|
|
Period 1: Epoch 1 (Ramp-up)
STARTED
|
37
|
|
Period 1: Epoch 1 (Ramp-up)
Treated in Epoch 1
|
37
|
|
Period 1: Epoch 1 (Ramp-up)
COMPLETED
|
36
|
|
Period 1: Epoch 1 (Ramp-up)
NOT COMPLETED
|
1
|
|
Period 2: Epoch 2
STARTED
|
36
|
|
Period 2: Epoch 2
Treated in Epoch 2
|
36
|
|
Period 2: Epoch 2
COMPLETED
|
1
|
|
Period 2: Epoch 2
NOT COMPLETED
|
35
|
|
Overall Trial (Incl. Safety Follow-up)
STARTED
|
37
|
|
Overall Trial (Incl. Safety Follow-up)
Treated in Epoch 1 (Ramp-up)
|
37
|
|
Overall Trial (Incl. Safety Follow-up)
Completed Epoch 1 (Ramp-up)
|
36
|
|
Overall Trial (Incl. Safety Follow-up)
Started Epoch 2
|
36
|
|
Overall Trial (Incl. Safety Follow-up)
Treated in Epoch 2
|
36
|
|
Overall Trial (Incl. Safety Follow-up)
Completed Epoch 2
|
1
|
|
Overall Trial (Incl. Safety Follow-up)
Switch to Safety Follow-up
|
26
|
|
Overall Trial (Incl. Safety Follow-up)
Completed Safety Follow-up
|
24
|
|
Overall Trial (Incl. Safety Follow-up)
COMPLETED
|
25
|
|
Overall Trial (Incl. Safety Follow-up)
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Subcutaneous Treatment With IGI, 10% and rHuPH20
Subcutaneous treatment with IGI, 10% and rHuPH20 occurred in 2 study epochs. In Epoch 1, PIDD patients that were already on intravenous (IV) or subcutaneous (SC) treatment were treated with IGI, 10% and rHuPH20 subcutaneously, with one 1-week dose and interval and one 2-week dose and interval. Epoch 2 was to consist of approx. 6 months (24 weeks) of IGI, 10% and rHuPH20 treatment. For subjects pretreated IV, this treatment was to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), depending on the subject´s previous IV dosing schedule. For subjects pretreated SC, treatment was also to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), at the discretion of the investigator and subject. However, treatment with rHuPH20 was stopped as of August 2012 following a discussion with the FDA, and subjects still active in Epoch 2 were switched to a safety follow-up. During the safety-follow up, subjects received IGI, 10% by either the IV or the SC route.
|
|---|---|
|
Period 1: Epoch 1 (Ramp-up)
Withdrawal by Subject
|
1
|
|
Period 2: Epoch 2
Withdrawal by Subject
|
6
|
|
Period 2: Epoch 2
Adverse Event
|
3
|
|
Period 2: Epoch 2
Switch to safety follow-up
|
26
|
|
Overall Trial (Incl. Safety Follow-up)
Withdrawal by Subject in Epoch 1
|
1
|
|
Overall Trial (Incl. Safety Follow-up)
Withdrawal by Subject in Epoch 2
|
6
|
|
Overall Trial (Incl. Safety Follow-up)
Adverse Event in Epoch 2
|
3
|
|
Overall Trial (Incl. Safety Follow-up)
Withdrawal During Safety-Follow-up
|
2
|
Baseline Characteristics
Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD
Baseline characteristics by cohort
| Measure |
Subcutaneous Treatment With IGI, 10% and rHuPH20
n=37 Participants
This analysis set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2. In Epoch 1, PIDD patients that were already on intravenous (IV) or subcutaneous (SC) treatment were treated with IGI, 10% and rHuPH20 subcutaneously, with one 1-week dose and interval and one 2-week dose and interval. Epoch 2 was to consist of approx. 6 months (24 weeks) of IGI, 10% and rHuPH20 treatment. For subjects pretreated IV, this treatment was to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), depending on the subject´s previous IV dosing schedule. For subjects pretreated SC, treatment was also to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), at the discretion of the investigator and subject. However, treatment with rHuPH20 was stopped as of August 2012 following a discussion with the FDA, and subjects still active in Epoch 2 were switched to a safety follow-up (IGI, 10% by IV or SC route).
|
|---|---|
|
Age, Categorical
<=18 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
33.0 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 months (per subject)Outcome measures
| Measure |
Safety Analysis Set (n=37)
n=37 Participants
The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
|
Epoch 2 Data Set (n=36)
The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
|
|---|---|---|
|
Number of Related Systemic Adverse Events (Excluding Infections)
|
59 adverse events
|
—
|
PRIMARY outcome
Timeframe: 7 months (per subject)A point estimate and 95% confidence interval for the rate of related systemic adverse events per infusion was derived using a Poisson model.
Outcome measures
| Measure |
Safety Analysis Set (n=37)
n=37 Participants
The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
|
Epoch 2 Data Set (n=36)
n=36 Participants
The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
|
|---|---|---|
|
Rate of Related Systemic Adverse Events (Excluding Infections) Per Infusion
Epoch 1
|
0.250 adverse events
Interval 0.14 to 0.406
|
0.253 adverse events
Interval 0.141 to 0.413
|
|
Rate of Related Systemic Adverse Events (Excluding Infections) Per Infusion
Epoch 2
|
0.377 adverse events
Interval 0.205 to 0.626
|
0.377 adverse events
Interval 0.205 to 0.626
|
|
Rate of Related Systemic Adverse Events (Excluding Infections) Per Infusion
Epoch 1+2
|
0.324 adverse events
Interval 0.187 to 0.517
|
0.326 adverse events
Interval 0.186 to 0.522
|
SECONDARY outcome
Timeframe: 6 months (per subject)Outcome measures
| Measure |
Safety Analysis Set (n=37)
n=36 Participants
The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
|
Epoch 2 Data Set (n=36)
The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
|
|---|---|---|
|
Proportion of Subjects Who Achieve a Treatment Interval of 3 or 4 Weeks in Epoch 2
3 or 4-week treatment interval
|
36 subjects
|
—
|
|
Proportion of Subjects Who Achieve a Treatment Interval of 3 or 4 Weeks in Epoch 2
3-week treatment interval
|
6 subjects
|
—
|
|
Proportion of Subjects Who Achieve a Treatment Interval of 3 or 4 Weeks in Epoch 2
4-week treatment interval
|
30 subjects
|
—
|
SECONDARY outcome
Timeframe: 6 months (per subject)Outcome measures
| Measure |
Safety Analysis Set (n=37)
n=36 Participants
The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
|
Epoch 2 Data Set (n=36)
The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
|
|---|---|---|
|
Proportion of Subjects Who Maintain a Treatment Interval of 3 or 4 Weeks in Epoch 2 for 24 Weeks
|
1 subjects
|
—
|
SECONDARY outcome
Timeframe: 7 months (per subject)Outcome measures
| Measure |
Safety Analysis Set (n=37)
n=37 Participants
The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
|
Epoch 2 Data Set (n=36)
The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
|
|---|---|---|
|
Number of Related Local Adverse Events (Excluding Infections)
|
153 adverse events
|
—
|
SECONDARY outcome
Timeframe: 7 months (per subject)A point estimate and 95% confidence interval for the rate of related local adverse events per infusion was derived using a Poisson model.
Outcome measures
| Measure |
Safety Analysis Set (n=37)
n=37 Participants
The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
|
Epoch 2 Data Set (n=36)
n=36 Participants
The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
|
|---|---|---|
|
Rate of Related Local Adverse Events (Excluding Infections) Per Infusion
Epoch 1
|
0.882 adverse events
Interval 0.581 to 1.271
|
0.880 adverse events
Interval 0.575 to 1.278
|
|
Rate of Related Local Adverse Events (Excluding Infections) Per Infusion
Epoch 2
|
0.811 adverse events
Interval 0.541 to 1.16
|
0.811 adverse events
Interval 0.541 to 1.16
|
|
Rate of Related Local Adverse Events (Excluding Infections) Per Infusion
Epoch 1+2
|
0.841 adverse events
Interval 0.587 to 1.159
|
0.840 adverse events
Interval 0.582 to 1.164
|
SECONDARY outcome
Timeframe: 7 months (per subject)Outcome measures
| Measure |
Safety Analysis Set (n=37)
n=37 Participants
The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
|
Epoch 2 Data Set (n=36)
The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
|
|---|---|---|
|
Number of All Related Adverse Events (Excluding Infections)
|
212 adverse events
|
—
|
SECONDARY outcome
Timeframe: 7 months (per subject)A point estimate and 95% confidence interval for the rate of adverse events per infusion was derived using a Poisson model.
Outcome measures
| Measure |
Safety Analysis Set (n=37)
n=37 Participants
The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
|
Epoch 2 Data Set (n=36)
n=36 Participants
The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
|
|---|---|---|
|
Rate of All Adverse Events (Excluding Infections) Per Infusion
Epoch 1
|
1.645 adverse events
Interval 1.221 to 2.157
|
1.653 adverse events
Interval 1.221 to 2.178
|
|
Rate of All Adverse Events (Excluding Infections) Per Infusion
Epoch 2
|
1.642 adverse events
Interval 1.164 to 2.235
|
1.642 adverse events
Interval 1.164 to 2.235
|
|
Rate of All Adverse Events (Excluding Infections) Per Infusion
Epoch 1+2
|
1.643 adverse events
Interval 1.235 to 2.132
|
1.646 adverse events
Interval 1.232 to 2.145
|
SECONDARY outcome
Timeframe: 7 months (per subject)Outcome measures
| Measure |
Safety Analysis Set (n=37)
n=37 Participants
The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
|
Epoch 2 Data Set (n=36)
The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
|
|---|---|---|
|
Number of Subjects Who Develop Neutralizing Antibodies to rHuPH20
|
0 subjects
|
—
|
SECONDARY outcome
Timeframe: 7 months (per subject)Population: At screening, data (ie, IgG trough levels) were available for analysis from 36 participants. At the end of Epoch 2, data were available for analysis from only 33 participants.
IgG trough levels at the beginning of Study Epoch 1 (previous immunoglobulin treatment) and at the end of Study Epoch 2 were analyzed.
Outcome measures
| Measure |
Safety Analysis Set (n=37)
n=36 Participants
The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
|
Epoch 2 Data Set (n=36)
The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
|
|---|---|---|
|
Trough Levels of Immunoglobulin G (IgG)
At screening
|
10.53 g/L
Interval 9.46 to 11.73
|
—
|
|
Trough Levels of Immunoglobulin G (IgG)
At end of Epoch 2
|
9.21 g/L
Interval 8.28 to 10.25
|
—
|
SECONDARY outcome
Timeframe: 7 months (per subject)Population: The number of participants analyzed for Epoch 1 is 37, as 37 participants were treated with study drug in Epoch 1. The number of participants analyzed for Epoch 2 is 36, as 36 participants were treated with study drug in Epoch 2.
Non-parametric descriptive statistics (median, range) are provided.
Outcome measures
| Measure |
Safety Analysis Set (n=37)
n=37 Participants
The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
|
Epoch 2 Data Set (n=36)
The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
|
|---|---|---|
|
Number of Infusions Per Month in Epoch 1 and Epoch 2
Epoch 1
|
2.90 infusions
Interval 2.5 to 10.1
|
—
|
|
Number of Infusions Per Month in Epoch 1 and Epoch 2
Epoch 2
|
1.09 infusions
Interval 0.6 to 2.0
|
—
|
SECONDARY outcome
Timeframe: 7 months (per subject)Population: The number of participants analyzed for Epoch 1 is 37, as 37 participants were treated with study drug in Epoch 1. The number of participants analyzed for Epoch 2 is 36, as 36 participants were treated with study drug in Epoch 2.
Non-parametric descriptive statistics (median, range) are provided.
Outcome measures
| Measure |
Safety Analysis Set (n=37)
n=37 Participants
The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
|
Epoch 2 Data Set (n=36)
The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
|
|---|---|---|
|
Number of Infusion Sites (Needle Sticks) Per Month in Epoch 1 and Epoch 2
Epoch 1
|
2.90 infusion sites (needle sticks)
Interval 2.5 to 10.1
|
—
|
|
Number of Infusion Sites (Needle Sticks) Per Month in Epoch 1 and Epoch 2
Epoch 2
|
1.12 infusion sites (needle sticks)
Interval 0.6 to 3.8
|
—
|
SECONDARY outcome
Timeframe: 7 months (per subject)Population: The number of participants analyzed for Epoch 1 is 37, as 37 participants were treated with study drug in Epoch 1. The number of participants analyzed for Epoch 2 is 36, as 36 participants were treated with study drug in Epoch 2.
Non-parametric descriptive statistics (median, range) are provided.
Outcome measures
| Measure |
Safety Analysis Set (n=37)
n=37 Participants
The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
|
Epoch 2 Data Set (n=36)
The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
|
|---|---|---|
|
Duration of Infusion in Epoch 1 and Epoch 2
Epoch 1
|
1.23 hours
Interval 0.53 to 3.1
|
—
|
|
Duration of Infusion in Epoch 1 and Epoch 2
Epoch 2
|
1.67 hours
Interval 0.8 to 3.55
|
—
|
SECONDARY outcome
Timeframe: 7 months (per subject)Population: The number of participants analyzed for Epoch 1 is 37, as 37 participants were treated with study drug in Epoch 1. The number of participants analyzed for Epoch 2 is 36, as 36 participants were treated with study drug in Epoch 2.
Non-parametric descriptive statistics (median, range) are provided.
Outcome measures
| Measure |
Safety Analysis Set (n=37)
n=37 Participants
The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
|
Epoch 2 Data Set (n=36)
The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
|
|---|---|---|
|
Maximum Infusion Rate in Epoch 1 and Epoch 2
Epoch 1
|
240.0 mL/h
Interval 60.0 to 300.0
|
—
|
|
Maximum Infusion Rate in Epoch 1 and Epoch 2
Epoch 2
|
300.0 mL/h
Interval 10.0 to 300.0
|
—
|
SECONDARY outcome
Timeframe: 7 months (per subject)Population: Of 36 participants treated with study drug in Epoch 2, 6 reached a final dose interval of 3 weeks and 30 reached a final dose interval of 4 weeks.
Non-parametric descriptive statistics (median, range) are provided.
Outcome measures
| Measure |
Safety Analysis Set (n=37)
n=36 Participants
The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
|
Epoch 2 Data Set (n=36)
The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
|
|---|---|---|
|
Number of Weeks to Reach Final 3 or 4-week Dose Interval
3-week dose interval
|
3.0 weeks
Interval 3.0 to 5.0
|
—
|
|
Number of Weeks to Reach Final 3 or 4-week Dose Interval
4-week dose interval
|
3.0 weeks
Interval 3.0 to 4.0
|
—
|
Adverse Events
Epochs 1+2 (SC Treatment w/ IGI,10% and rHuPH20, n=37)
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Safety Follow-up (n=26)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Epochs 1+2 (SC Treatment w/ IGI,10% and rHuPH20, n=37)
n=37 participants at risk
This analysis set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2. In Epoch 1, PIDD patients that were already on intravenous (IV) or subcutaneous (SC) treatment were treated with IGI, 10% and rHuPH20 subcutaneously, with one 1-week dose and interval and one 2-week dose and interval. Epoch 2 was to consist of approx. 6 months (24 weeks) of IGI, 10% and rHuPH20 treatment. For subjects pretreated IV, this treatment was to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), depending on the subject´s previous IV dosing schedule. For subjects pretreated SC, treatment was also to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), at the discretion of the investigator and subject. However, treatment with rHuPH20 was stopped as of August 2012 following a discussion with the FDA, and subjects still active in Epoch 2 were switched to a safety follow-up (IGI, 10% by IV or SC route).
|
Safety Follow-up (n=26)
n=26 participants at risk
Treatment with rHuPH20 was stopped as of August 2012 following discussion with the FDA. This decision was based on theoretical risks of exposure to anti-rHuPH20 antibodies, not because of any clinical adverse events. 26 subjects still active in Epoch 2 of the study went into a safety follow-up period and were treated with IGI, 10% (GAMMAGARD LIQUID) either intravenously or subcutaneously.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/37 • Overall: Approximately 1 year Per subject: 7 months
|
3.8%
1/26 • Number of events 1 • Overall: Approximately 1 year Per subject: 7 months
|
Other adverse events
| Measure |
Epochs 1+2 (SC Treatment w/ IGI,10% and rHuPH20, n=37)
n=37 participants at risk
This analysis set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2. In Epoch 1, PIDD patients that were already on intravenous (IV) or subcutaneous (SC) treatment were treated with IGI, 10% and rHuPH20 subcutaneously, with one 1-week dose and interval and one 2-week dose and interval. Epoch 2 was to consist of approx. 6 months (24 weeks) of IGI, 10% and rHuPH20 treatment. For subjects pretreated IV, this treatment was to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), depending on the subject´s previous IV dosing schedule. For subjects pretreated SC, treatment was also to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), at the discretion of the investigator and subject. However, treatment with rHuPH20 was stopped as of August 2012 following a discussion with the FDA, and subjects still active in Epoch 2 were switched to a safety follow-up (IGI, 10% by IV or SC route).
|
Safety Follow-up (n=26)
n=26 participants at risk
Treatment with rHuPH20 was stopped as of August 2012 following discussion with the FDA. This decision was based on theoretical risks of exposure to anti-rHuPH20 antibodies, not because of any clinical adverse events. 26 subjects still active in Epoch 2 of the study went into a safety follow-up period and were treated with IGI, 10% (GAMMAGARD LIQUID) either intravenously or subcutaneously.
|
|---|---|---|
|
Gastrointestinal disorders
Upper abdominal pain
|
5.4%
2/37 • Number of events 2 • Overall: Approximately 1 year Per subject: 7 months
|
0.00%
0/26 • Overall: Approximately 1 year Per subject: 7 months
|
|
Gastrointestinal disorders
Diarrhea
|
8.1%
3/37 • Number of events 3 • Overall: Approximately 1 year Per subject: 7 months
|
0.00%
0/26 • Overall: Approximately 1 year Per subject: 7 months
|
|
Gastrointestinal disorders
Nausea
|
13.5%
5/37 • Number of events 10 • Overall: Approximately 1 year Per subject: 7 months
|
3.8%
1/26 • Number of events 2 • Overall: Approximately 1 year Per subject: 7 months
|
|
Gastrointestinal disorders
Vomiting
|
5.4%
2/37 • Number of events 2 • Overall: Approximately 1 year Per subject: 7 months
|
0.00%
0/26 • Overall: Approximately 1 year Per subject: 7 months
|
|
General disorders
Fatigue
|
16.2%
6/37 • Number of events 6 • Overall: Approximately 1 year Per subject: 7 months
|
0.00%
0/26 • Overall: Approximately 1 year Per subject: 7 months
|
|
General disorders
Infusion site discoloration
|
10.8%
4/37 • Number of events 11 • Overall: Approximately 1 year Per subject: 7 months
|
0.00%
0/26 • Overall: Approximately 1 year Per subject: 7 months
|
|
General disorders
Infusion site erythema
|
29.7%
11/37 • Number of events 26 • Overall: Approximately 1 year Per subject: 7 months
|
0.00%
0/26 • Overall: Approximately 1 year Per subject: 7 months
|
|
General disorders
Infusion site hematoma
|
5.4%
2/37 • Number of events 2 • Overall: Approximately 1 year Per subject: 7 months
|
0.00%
0/26 • Overall: Approximately 1 year Per subject: 7 months
|
|
General disorders
Infusion site pain
|
56.8%
21/37 • Number of events 64 • Overall: Approximately 1 year Per subject: 7 months
|
0.00%
0/26 • Overall: Approximately 1 year Per subject: 7 months
|
|
General disorders
Infusion site pruritus
|
13.5%
5/37 • Number of events 8 • Overall: Approximately 1 year Per subject: 7 months
|
0.00%
0/26 • Overall: Approximately 1 year Per subject: 7 months
|
|
General disorders
Infusion site swelling
|
24.3%
9/37 • Number of events 23 • Overall: Approximately 1 year Per subject: 7 months
|
0.00%
0/26 • Overall: Approximately 1 year Per subject: 7 months
|
|
General disorders
Injection site pain
|
5.4%
2/37 • Number of events 3 • Overall: Approximately 1 year Per subject: 7 months
|
0.00%
0/26 • Overall: Approximately 1 year Per subject: 7 months
|
|
General disorders
Injection site reaction
|
5.4%
2/37 • Number of events 2 • Overall: Approximately 1 year Per subject: 7 months
|
0.00%
0/26 • Overall: Approximately 1 year Per subject: 7 months
|
|
General disorders
Local swelling
|
10.8%
4/37 • Number of events 9 • Overall: Approximately 1 year Per subject: 7 months
|
0.00%
0/26 • Overall: Approximately 1 year Per subject: 7 months
|
|
General disorders
Pain
|
8.1%
3/37 • Number of events 4 • Overall: Approximately 1 year Per subject: 7 months
|
3.8%
1/26 • Number of events 2 • Overall: Approximately 1 year Per subject: 7 months
|
|
General disorders
Pyrexia
|
13.5%
5/37 • Number of events 6 • Overall: Approximately 1 year Per subject: 7 months
|
7.7%
2/26 • Number of events 4 • Overall: Approximately 1 year Per subject: 7 months
|
|
Infections and infestations
Bronchitis
|
5.4%
2/37 • Number of events 2 • Overall: Approximately 1 year Per subject: 7 months
|
3.8%
1/26 • Number of events 1 • Overall: Approximately 1 year Per subject: 7 months
|
|
Infections and infestations
Pharyngitis
|
5.4%
2/37 • Number of events 2 • Overall: Approximately 1 year Per subject: 7 months
|
3.8%
1/26 • Number of events 1 • Overall: Approximately 1 year Per subject: 7 months
|
|
Infections and infestations
Sinusitis
|
13.5%
5/37 • Number of events 5 • Overall: Approximately 1 year Per subject: 7 months
|
7.7%
2/26 • Number of events 2 • Overall: Approximately 1 year Per subject: 7 months
|
|
Infections and infestations
Upper respiratory tract infection
|
2.7%
1/37 • Number of events 1 • Overall: Approximately 1 year Per subject: 7 months
|
11.5%
3/26 • Number of events 3 • Overall: Approximately 1 year Per subject: 7 months
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
5.4%
2/37 • Number of events 3 • Overall: Approximately 1 year Per subject: 7 months
|
0.00%
0/26 • Overall: Approximately 1 year Per subject: 7 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.4%
2/37 • Number of events 3 • Overall: Approximately 1 year Per subject: 7 months
|
0.00%
0/26 • Overall: Approximately 1 year Per subject: 7 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.8%
4/37 • Number of events 8 • Overall: Approximately 1 year Per subject: 7 months
|
3.8%
1/26 • Number of events 1 • Overall: Approximately 1 year Per subject: 7 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.4%
2/37 • Number of events 2 • Overall: Approximately 1 year Per subject: 7 months
|
0.00%
0/26 • Overall: Approximately 1 year Per subject: 7 months
|
|
Nervous system disorders
Dizziness
|
5.4%
2/37 • Number of events 2 • Overall: Approximately 1 year Per subject: 7 months
|
0.00%
0/26 • Overall: Approximately 1 year Per subject: 7 months
|
|
Nervous system disorders
Headache
|
27.0%
10/37 • Number of events 25 • Overall: Approximately 1 year Per subject: 7 months
|
11.5%
3/26 • Number of events 3 • Overall: Approximately 1 year Per subject: 7 months
|
|
Psychiatric disorders
Insomnia
|
5.4%
2/37 • Number of events 2 • Overall: Approximately 1 year Per subject: 7 months
|
0.00%
0/26 • Overall: Approximately 1 year Per subject: 7 months
|
|
Renal and urinary disorders
Hemosiderinuria
|
8.1%
3/37 • Number of events 3 • Overall: Approximately 1 year Per subject: 7 months
|
0.00%
0/26 • Overall: Approximately 1 year Per subject: 7 months
|
|
Reproductive system and breast disorders
Vulvovaginal swelling
|
5.4%
2/37 • Number of events 2 • Overall: Approximately 1 year Per subject: 7 months
|
0.00%
0/26 • Overall: Approximately 1 year Per subject: 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.8%
4/37 • Number of events 4 • Overall: Approximately 1 year Per subject: 7 months
|
0.00%
0/26 • Overall: Approximately 1 year Per subject: 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.4%
2/37 • Number of events 2 • Overall: Approximately 1 year Per subject: 7 months
|
0.00%
0/26 • Overall: Approximately 1 year Per subject: 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.4%
2/37 • Number of events 2 • Overall: Approximately 1 year Per subject: 7 months
|
7.7%
2/26 • Number of events 2 • Overall: Approximately 1 year Per subject: 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
5.4%
2/37 • Number of events 2 • Overall: Approximately 1 year Per subject: 7 months
|
0.00%
0/26 • Overall: Approximately 1 year Per subject: 7 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Baxalta's agreements with PIs may vary per requirements of individual PI, but contain common elements. For this study, PIs are restricted from independently publishing results until the earlier of the primary multicenter publication or 12 months after study completion. Baxalta requires a review of results communications (e.g., for confidential information) ≥90 days prior to submission or communication. Baxalta may request an additional delay of ≤60 days eg, for intellectual property protection.
- Publication restrictions are in place
Restriction type: OTHER