Trial Outcomes & Findings for Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (EU Extension Study) (NCT NCT00751621)
NCT ID: NCT00751621
Last Updated: 2014-04-02
Results Overview
The IgG trough values per subject were aggregated to a median value, and then median values across subjects were summarized using descriptive statistics.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
40 participants
Primary outcome timeframe
Up to 42 months
Results posted on
2014-04-02
Participant Flow
Subjects who had previously participated in the pivotal study ZLB06\_001CR (NCT00542997) were enrolled in the extension study ZLB07\_002CR.
Participant milestones
| Measure |
IgPro20
Subcutaneous (SC) administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06\_001CR (NCT00542997).
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
IgPro20
Subcutaneous (SC) administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06\_001CR (NCT00542997).
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Subject moved to another country
|
1
|
|
Overall Study
Poor adherence to asthma treatment
|
1
|
Baseline Characteristics
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (EU Extension Study)
Baseline characteristics by cohort
| Measure |
IgPro20
n=40 Participants
Subcutaneous (SC) administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06\_001CR (NCT00542997).
|
|---|---|
|
Age, Customized
2 to < 12 years
|
15 participants
n=5 Participants
|
|
Age, Customized
12 to < 16 years
|
4 participants
n=5 Participants
|
|
Age, Customized
16 to < 65 years
|
21 participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
0 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 42 monthsPopulation: The "all treated" (AT) safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the "Full Analysis/intention-to-treat" (ITT) data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.
The IgG trough values per subject were aggregated to a median value, and then median values across subjects were summarized using descriptive statistics.
Outcome measures
| Measure |
IgPro20
n=40 Participants
Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06\_001CR (NCT00542997).
|
IgPro20 - At End of Study
SF-36 score at end of study (defined as the last available post-baseline observation for each subject).
|
|---|---|---|
|
Total Serum IgG Trough Levels
|
7.97 g/L
Standard Deviation 1.171
|
—
|
SECONDARY outcome
Timeframe: Up to 42 monthsPopulation: The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.
The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. Potential SBIs included bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an adverse event (AE) was identified as a potential SBI, the AE was adjudicated by the Medical Monitor and Investigator to determine if the event fulfilled the predefined criteria for SBIs.
Outcome measures
| Measure |
IgPro20
n=38208 Subject Study Days
Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06\_001CR (NCT00542997).
|
IgPro20 - At End of Study
SF-36 score at end of study (defined as the last available post-baseline observation for each subject).
|
|---|---|---|
|
Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs)
Annualized Rate
|
0.048 SBIs per subject year
|
—
|
|
Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs)
Upper 1-sided 99% Confidence Limit
|
0.1252 SBIs per subject year
|
—
|
SECONDARY outcome
Timeframe: Up to 42 monthsPopulation: The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.
The annualized rate was based on the total number of infection episodes occurring during the study divided by the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.
Outcome measures
| Measure |
IgPro20
n=38208 Subject Study Days
Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06\_001CR (NCT00542997).
|
IgPro20 - At End of Study
SF-36 score at end of study (defined as the last available post-baseline observation for each subject).
|
|---|---|---|
|
Annualized Rate of Infection Episodes
|
3.334 infection episodes per subject year
Interval 2.993 to 3.703
|
—
|
SECONDARY outcome
Timeframe: Up to 42 monthsPopulation: The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.
Total number of infections for the specified analysis population
Outcome measures
| Measure |
IgPro20
n=40 Participants
Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06\_001CR (NCT00542997).
|
IgPro20 - At End of Study
SF-36 score at end of study (defined as the last available post-baseline observation for each subject).
|
|---|---|---|
|
Number of Infection Episodes
|
349 infection episodes
|
—
|
SECONDARY outcome
Timeframe: Up to 42 monthsPopulation: The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.
The annualized rate was based on the total number of days out of work / school / kindergarten / day care or inability to perform normal activities due to infection, and the total number of subject diary days for all subjects in the specified analysis population and adjusted to 365 days.
Outcome measures
| Measure |
IgPro20
n=38045 Subject Diary Days
Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06\_001CR (NCT00542997).
|
IgPro20 - At End of Study
SF-36 score at end of study (defined as the last available post-baseline observation for each subject).
|
|---|---|---|
|
Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections
|
6.773 days per subject year
|
—
|
SECONDARY outcome
Timeframe: Up to 42 monthsPopulation: The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.
Total number of days out of work / school / kindergarten / day care or unable to perform normal activities due to infections, for the specified analysis population
Outcome measures
| Measure |
IgPro20
n=40 Participants
Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06\_001CR (NCT00542997).
|
IgPro20 - At End of Study
SF-36 score at end of study (defined as the last available post-baseline observation for each subject).
|
|---|---|---|
|
Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections
|
706 days
|
—
|
SECONDARY outcome
Timeframe: Up to 42 monthsPopulation: The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.
The annualized rate was based on the total number of days of hospitalization due to infections and the total number of subject diary days for all subjects in the specified analysis population and adjusted to 365 days.
Outcome measures
| Measure |
IgPro20
n=38045 Subject Diary Days
Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06\_001CR (NCT00542997).
|
IgPro20 - At End of Study
SF-36 score at end of study (defined as the last available post-baseline observation for each subject).
|
|---|---|---|
|
Annualized Rate of Hospitalization Due to Infections
|
1.055 days per subject year
|
—
|
SECONDARY outcome
Timeframe: Up to 42 monthsPopulation: The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.
Total number of days of hospitalization due to infections for the specified analysis population
Outcome measures
| Measure |
IgPro20
n=40 Participants
Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06\_001CR (NCT00542997).
|
IgPro20 - At End of Study
SF-36 score at end of study (defined as the last available post-baseline observation for each subject).
|
|---|---|---|
|
Number of Days of Hospitalization Due to Infections
|
110 days
|
—
|
SECONDARY outcome
Timeframe: Up to 42 monthsPopulation: The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.
Annualized rate of days with antibiotics for infection prophylaxis and treatment. The annualized rate was based on the total number of days of antibiotic use for infection prophylaxis and treatment in the efficacy period, and the total number of subject study days for all subjects in the specified analysis population, and adjusted to 365 days.
Outcome measures
| Measure |
IgPro20
n=38208 Subject Study Days
Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06\_001CR (NCT00542997).
|
IgPro20 - At End of Study
SF-36 score at end of study (defined as the last available post-baseline observation for each subject).
|
|---|---|---|
|
Use of Antibiotics for Infection Prophylaxis and Treatment
|
72.13 days per subject year
|
—
|
SECONDARY outcome
Timeframe: At baseline and at the last available post-baseline observation for each subject (up to 42 months)Population: The analysis population comprised the Full-Analysis health related quality of life (HRQL) data set (defined as all subjects entered into the study who complete a baseline and at least 1 follow-up HRQL assessment), who were at least 15 years of age.
The Short Form 36 Health Survey (SF-36) is a 36-item questionnaire that measures generic health concepts that are relevant across age, disease, and treatment groups. The questions are grouped into eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100, with higher scores indicating a better health state.
Outcome measures
| Measure |
IgPro20
n=20 Participants
Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06\_001CR (NCT00542997).
|
IgPro20 - At End of Study
n=20 Participants
SF-36 score at end of study (defined as the last available post-baseline observation for each subject).
|
|---|---|---|
|
Health Related Quality of Life (Short Form 36 Health Survey)
Physical Functioning
|
95.0 score on a scale
Interval 75.0 to 100.0
|
100.0 score on a scale
Interval 20.0 to 100.0
|
|
Health Related Quality of Life (Short Form 36 Health Survey)
Role-physical
|
100.0 score on a scale
Interval 18.8 to 100.0
|
100.0 score on a scale
Interval 37.5 to 100.0
|
|
Health Related Quality of Life (Short Form 36 Health Survey)
Role-emotional
|
100.0 score on a scale
Interval 25.0 to 100.0
|
100.0 score on a scale
Interval 25.0 to 100.0
|
|
Health Related Quality of Life (Short Form 36 Health Survey)
Social Functioning
|
100.0 score on a scale
Interval 62.5 to 100.0
|
100.0 score on a scale
Interval 37.5 to 100.0
|
|
Health Related Quality of Life (Short Form 36 Health Survey)
Bodily Pain
|
84.0 score on a scale
Interval 22.0 to 100.0
|
84.0 score on a scale
Interval 22.0 to 100.0
|
|
Health Related Quality of Life (Short Form 36 Health Survey)
Mental Health
|
85.0 score on a scale
Interval 55.0 to 95.0
|
80.0 score on a scale
Interval 35.0 to 95.0
|
|
Health Related Quality of Life (Short Form 36 Health Survey)
Vitality
|
65.6 score on a scale
Interval 31.3 to 81.3
|
75.0 score on a scale
Interval 18.8 to 100.0
|
|
Health Related Quality of Life (Short Form 36 Health Survey)
General Health
|
52.0 score on a scale
Interval 15.0 to 82.0
|
54.5 score on a scale
Interval 20.0 to 92.0
|
SECONDARY outcome
Timeframe: At baseline (data either from Infusion 40 or the completion visit of study ZLB06_001CR), and at completion (up to 42 months).Population: The AT safety data set (which comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available) and for whom vital signs data was collected at both baseline and completion.
The total number of subjects with clinically relevant changes in vital signs from baseline to the completion visit. Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.
Outcome measures
| Measure |
IgPro20
n=39 Participants
Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06\_001CR (NCT00542997).
|
IgPro20 - At End of Study
SF-36 score at end of study (defined as the last available post-baseline observation for each subject).
|
|---|---|---|
|
Clinically Relevant Changes in Vital Signs From Baseline to the Completion Visit.
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: At baseline (data either from Infusion 40 or the completion visit of study ZLB06_001CR), and at completion (up to 42 months).Population: The AT safety data set (which comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available) and for whom laboratory parameter data was collected at both baseline and completion.
The total number of subjects with clinically significant abnormal changes in routine laboratory parameters between baseline and the completion visit. Routine laboratory parameters included haematology, serum chemistry and urinalysis.
Outcome measures
| Measure |
IgPro20
n=40 Participants
Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06\_001CR (NCT00542997).
|
IgPro20 - At End of Study
SF-36 score at end of study (defined as the last available post-baseline observation for each subject).
|
|---|---|---|
|
Clinically Significant Abnormal Changes in Routine Laboratory Parameters Between Baseline and the Completion Visit.
Haematology
|
3 participants
|
—
|
|
Clinically Significant Abnormal Changes in Routine Laboratory Parameters Between Baseline and the Completion Visit.
Serum Chemistry
|
1 participants
|
—
|
|
Clinically Significant Abnormal Changes in Routine Laboratory Parameters Between Baseline and the Completion Visit.
Urinalysis
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Up to 42 monthsPopulation: The AT safety data set comprised all subjects treated with IgPro20 during any study period.
The rate of AEs was the number of AEs over the number of infusions administered. Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.
Outcome measures
| Measure |
IgPro20
n=5405 Number of Infusions
Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06\_001CR (NCT00542997).
|
IgPro20 - At End of Study
SF-36 score at end of study (defined as the last available post-baseline observation for each subject).
|
|---|---|---|
|
Rate, Severity and Relatedness of Any Adverse Events (AEs) Per Infusion
Total AEs
|
0.0936 AEs per infusion
|
—
|
|
Rate, Severity and Relatedness of Any Adverse Events (AEs) Per Infusion
Mild AEs
|
0.0685 AEs per infusion
|
—
|
|
Rate, Severity and Relatedness of Any Adverse Events (AEs) Per Infusion
Moderate AEs
|
0.0231 AEs per infusion
|
—
|
|
Rate, Severity and Relatedness of Any Adverse Events (AEs) Per Infusion
Severe AEs
|
0.0020 AEs per infusion
|
—
|
|
Rate, Severity and Relatedness of Any Adverse Events (AEs) Per Infusion
At least possibly related AEs
|
0.0026 AEs per infusion
|
—
|
|
Rate, Severity and Relatedness of Any Adverse Events (AEs) Per Infusion
Serious AEs
|
0.0033 AEs per infusion
|
—
|
|
Rate, Severity and Relatedness of Any Adverse Events (AEs) Per Infusion
At least possibly related and serious AEs
|
0 AEs per infusion
|
—
|
Adverse Events
IgPro20
Serious events: 14 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IgPro20
n=40 participants at risk
Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06\_001CR (NCT00542997).
|
|---|---|
|
Infections and infestations
Pneumonia bacterial
|
12.5%
5/40 • Number of events 5 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Injury, poisoning and procedural complications
Concussion
|
2.5%
1/40 • Number of events 1 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
2.5%
1/40 • Number of events 1 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
1/40 • Number of events 1 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Injury, poisoning and procedural complications
Fracture
|
2.5%
1/40 • Number of events 1 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Gastrointestinal disorders
Coeliac disease
|
2.5%
1/40 • Number of events 1 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
1/40 • Number of events 1 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Blood and lymphatic system disorders
Thrombocytopenic purpura
|
2.5%
1/40 • Number of events 1 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Pneumonia
|
2.5%
1/40 • Number of events 1 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.5%
1/40 • Number of events 1 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Septic shock
|
2.5%
1/40 • Number of events 1 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
2.5%
1/40 • Number of events 1 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
General disorders
Face oedema
|
2.5%
1/40 • Number of events 1 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
2.5%
1/40 • Number of events 1 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
Other adverse events
| Measure |
IgPro20
n=40 participants at risk
Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06\_001CR (NCT00542997).
|
|---|---|
|
Infections and infestations
Bronchitis
|
52.5%
21/40 • Number of events 51 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Upper respiratory tract infection
|
45.0%
18/40 • Number of events 49 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Sinusitis
|
32.5%
13/40 • Number of events 31 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Nasopharyngitis
|
30.0%
12/40 • Number of events 19 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Rhinitis
|
22.5%
9/40 • Number of events 15 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Febrile infection
|
15.0%
6/40 • Number of events 10 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Acute sinusitis
|
12.5%
5/40 • Number of events 5 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Pharyngitis
|
12.5%
5/40 • Number of events 10 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Influenza
|
10.0%
4/40 • Number of events 4 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Viral infection
|
10.0%
4/40 • Number of events 4 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
10.0%
4/40 • Number of events 5 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Conjunctivitis infective
|
7.5%
3/40 • Number of events 11 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Ear infection
|
7.5%
3/40 • Number of events 6 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Enteritis infectious
|
7.5%
3/40 • Number of events 12 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Lower respiratory tract infection
|
7.5%
3/40 • Number of events 6 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Oral herpes
|
7.5%
3/40 • Number of events 8 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Otitis media
|
7.5%
3/40 • Number of events 8 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Pneumonia
|
5.0%
2/40 • Number of events 2 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Urinary tract infection
|
7.5%
3/40 • Number of events 6 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Acute tonsillitis
|
5.0%
2/40 • Number of events 3 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Diarrhoea infectious
|
5.0%
2/40 • Number of events 3 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Enterobiasis
|
5.0%
2/40 • Number of events 3 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Gastroenteritis
|
5.0%
2/40 • Number of events 2 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Laryngitis
|
5.0%
2/40 • Number of events 6 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Otitis externa
|
5.0%
2/40 • Number of events 2 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Otitis media acute
|
5.0%
2/40 • Number of events 2 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.5%
11/40 • Number of events 34 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
7.5%
3/40 • Number of events 4 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.0%
2/40 • Number of events 4 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.0%
2/40 • Number of events 2 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
4/40 • Number of events 9 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.5%
3/40 • Number of events 5 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
7.5%
3/40 • Number of events 3 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Gastrointestinal disorders
Constipation
|
5.0%
2/40 • Number of events 2 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Gastrointestinal disorders
Gastritis
|
5.0%
2/40 • Number of events 2 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
General disorders
Pyrexia
|
10.0%
4/40 • Number of events 6 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
General disorders
Chest pain
|
5.0%
2/40 • Number of events 2 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
5.0%
2/40 • Number of events 2 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
2/40 • Number of events 2 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.0%
6/40 • Number of events 7 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.5%
3/40 • Number of events 3 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
2/40 • Number of events 2 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.0%
2/40 • Number of events 3 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.0%
2/40 • Number of events 2 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Nervous system disorders
Dizziness
|
5.0%
2/40 • Number of events 3 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Nervous system disorders
Headache
|
5.0%
2/40 • Number of events 6 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Nervous system disorders
Sciatica
|
5.0%
2/40 • Number of events 2 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Investigations
Weight increased
|
7.5%
3/40 • Number of events 5 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Surgical and medical procedures
Wisdom teeth removal
|
5.0%
2/40 • Number of events 2 • AEs were collected for the duration of the study, up to 42 months.
A total of 5405 weekly infusions of IgPro20 were administered to 40 subjects in this study. Three subjects received fewer than 100 infusions. The AT safety data set comprised all subjects treated with IgPro20 during any study period. AEs in "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER