Trial Outcomes & Findings for A Study of NewGam, Human Immunoglobulin 10%, in Patients With Primary Immunodeficiency Diseases (NCT NCT01012323)
NCT ID: NCT01012323
Last Updated: 2017-03-16
Results Overview
The number of serious bacterial infections per person-year of treatment was calculated by the following formula: Total number of serious bacterial infections / patient-years on NewGam treatment. Serious bacterial infections were defined as bacteraemia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess.
COMPLETED
PHASE3
51 participants
Baseline to end of the study (up to 12 months)
2017-03-16
Participant Flow
Participant milestones
| Measure |
NewGam
Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
NewGam
Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
|
|---|---|
|
Overall Study
Investigator Judgment
|
1
|
Baseline Characteristics
A Study of NewGam, Human Immunoglobulin 10%, in Patients With Primary Immunodeficiency Diseases
Baseline characteristics by cohort
| Measure |
NewGam
n=51 Participants
Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
|
|---|---|
|
Age, Continuous
|
26.8 Years
STANDARD_DEVIATION 19.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of the study (up to 12 months)Population: Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.
The number of serious bacterial infections per person-year of treatment was calculated by the following formula: Total number of serious bacterial infections / patient-years on NewGam treatment. Serious bacterial infections were defined as bacteraemia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess.
Outcome measures
| Measure |
NewGam
n=51 Participants
Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
|
|---|---|
|
Number of Serious Bacterial Infections Per Person-year of Treatment
|
0.080 Serious infections per person-year of tr
|
SECONDARY outcome
Timeframe: Baseline to end of the study (up to 12 months)Population: Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.
Total IgG trough concentrations were measured in serum samples taken before each infusion.
Outcome measures
| Measure |
NewGam
n=51 Participants
Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
|
|---|---|
|
IgG Trough Level Concentration
Infusion 1
|
9.91 g/L
Standard Deviation 2.845
|
|
IgG Trough Level Concentration
Termination visit
|
10.32 g/L
Standard Deviation 3.429
|
SECONDARY outcome
Timeframe: Baseline to end of the study (up to 12 months)Population: Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.
Trough level concentrations of antibodies against Haemophilus influenzae were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants.
Outcome measures
| Measure |
NewGam
n=51 Participants
Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
|
|---|---|
|
Trough Level Concentration of Antibodies Against Haemophilus Influenzae
Infusion 1
|
1.96 µg/mL
Standard Deviation 1.473
|
|
Trough Level Concentration of Antibodies Against Haemophilus Influenzae
Termination visit
|
2.51 µg/mL
Standard Deviation 1.765
|
SECONDARY outcome
Timeframe: Baseline to end of the study (up to 12 months)Population: Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.
Trough level concentrations of antibodies against measles were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants.
Outcome measures
| Measure |
NewGam
n=51 Participants
Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
|
|---|---|
|
Trough Level Concentration of Antibodies Against Measles
Infusion 1
|
854.08 mIU/mL
Standard Deviation 455.220
|
|
Trough Level Concentration of Antibodies Against Measles
Termination visit
|
1257.76 mIU/mL
Standard Deviation 706.276
|
SECONDARY outcome
Timeframe: Baseline to end of the study (up to 12 months)Population: Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.
Trough level concentrations of antibodies against Streptococcus pneumoniae (serotypes types 6B, 14, 9V, 18C, 19F, 4, and 23F) were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants.
Outcome measures
| Measure |
NewGam
n=51 Participants
Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
|
|---|---|
|
Trough Level Concentration of Antibodies Against Streptococcus Pneumoniae
Infusion 1 - serotype 4
|
1.03 µg/mL
Standard Deviation 0.680
|
|
Trough Level Concentration of Antibodies Against Streptococcus Pneumoniae
Termination visit - serotype 4
|
1.10 µg/mL
Standard Deviation 0.673
|
|
Trough Level Concentration of Antibodies Against Streptococcus Pneumoniae
Infusion 1 - serotype 6B
|
1.97 µg/mL
Standard Deviation 1.226
|
|
Trough Level Concentration of Antibodies Against Streptococcus Pneumoniae
Termination visit - serotype 6B
|
2.10 µg/mL
Standard Deviation 1.134
|
|
Trough Level Concentration of Antibodies Against Streptococcus Pneumoniae
Infusion 1 - serotype 9V
|
1.86 µg/mL
Standard Deviation 0.938
|
|
Trough Level Concentration of Antibodies Against Streptococcus Pneumoniae
Termination visit - serotype 9V
|
1.95 µg/mL
Standard Deviation 0.942
|
|
Trough Level Concentration of Antibodies Against Streptococcus Pneumoniae
Infusion 1 - serotype 14
|
7.21 µg/mL
Standard Deviation 4.355
|
|
Trough Level Concentration of Antibodies Against Streptococcus Pneumoniae
Termination visit - serotype 14
|
7.97 µg/mL
Standard Deviation 5.057
|
|
Trough Level Concentration of Antibodies Against Streptococcus Pneumoniae
Infusion 1 - serotype 18C
|
2.28 µg/mL
Standard Deviation 2.234
|
|
Trough Level Concentration of Antibodies Against Streptococcus Pneumoniae
Termination visit - serotype 18C
|
2.38 µg/mL
Standard Deviation 2.077
|
|
Trough Level Concentration of Antibodies Against Streptococcus Pneumoniae
Infusion 1 - serotype 19F
|
6.56 µg/mL
Standard Deviation 4.272
|
|
Trough Level Concentration of Antibodies Against Streptococcus Pneumoniae
Termination visit - serotype 19F
|
6.41 µg/mL
Standard Deviation 3.843
|
|
Trough Level Concentration of Antibodies Against Streptococcus Pneumoniae
Infusion 1 - serotype 23F
|
1.87 µg/mL
Standard Deviation 1.102
|
|
Trough Level Concentration of Antibodies Against Streptococcus Pneumoniae
Termination visit - serotype 23F
|
2.03 µg/mL
Standard Deviation 0.918
|
SECONDARY outcome
Timeframe: Baseline to end of the study (up to 12 months)Population: Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.
Trough level concentrations of antibodies against cytomegalovirus were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants.
Outcome measures
| Measure |
NewGam
n=51 Participants
Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
|
|---|---|
|
Trough Level Concentration of Antibodies Against Cytomegalovirus
Infusion 1
|
30.75 U
Standard Deviation 6.823
|
|
Trough Level Concentration of Antibodies Against Cytomegalovirus
Termination visit
|
30.16 U
Standard Deviation 6.670
|
SECONDARY outcome
Timeframe: Baseline to end of the study (up to 12 months)Population: Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.
Trough level concentrations of antibodies against tetanus were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants.
Outcome measures
| Measure |
NewGam
n=51 Participants
Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
|
|---|---|
|
Trough Level Concentration of Antibodies Against Tetanus
Infusion 1
|
2.70 IU/mL
Standard Deviation 1.467
|
|
Trough Level Concentration of Antibodies Against Tetanus
Termination visit
|
2.37 IU/mL
Standard Deviation 1.389
|
SECONDARY outcome
Timeframe: Baseline to end of the study (up to 12 months)Population: Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.
Trough level concentrations of antibodies against varicella-zoster virus were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants.
Outcome measures
| Measure |
NewGam
n=51 Participants
Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
|
|---|---|
|
Trough Level Concentration of Antibodies Against Varicella-zoster Virus
Infusion 1
|
125.13 U/mL
Standard Deviation 36.490
|
|
Trough Level Concentration of Antibodies Against Varicella-zoster Virus
Termination visit
|
119.02 U/mL
Standard Deviation 40.457
|
SECONDARY outcome
Timeframe: Baseline to end of the study (up to 12 months)Population: Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.
The number of infections included serious bacterial infections (bacterial pneumonia, bacteraemia/sepsis, osteomyelitis/septic arthritis, visceral abscess, bacterial meningitis) and other infections. For other infections, the Medical Dictionary for Regulatory Activities (MedDRA) preferred term was used to determine the type of infection. They were grouped into the following categories as determined by a medical expert: Ear infections, eye infections, infections of the gastrointestinal tract, infections of the genitourinary tract, upper respiratory tract infections, lower respiratory tract infections, infections of the skin, and infections not elsewhere classified.
Outcome measures
| Measure |
NewGam
n=51 Participants
Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
|
|---|---|
|
Total Number of Infections
|
189 Infections
|
SECONDARY outcome
Timeframe: Baseline to end of the study (up to 12 months)Population: Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.
The MedDRA preferred term was used to determine the type of non-serious infection. They were grouped into the following categories as determined by a medical expert: Ear infections, eye infections, infections of the gastrointestinal tract, infections of the genitourinary tract, upper respiratory tract infections, lower respiratory tract infections, infections of the skin, and infections not elsewhere classified. The total number of infections and the number in each category are reported.
Outcome measures
| Measure |
NewGam
n=51 Participants
Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
|
|---|---|
|
Number of Non-serious Infections
All infections
|
185 Infections
|
|
Number of Non-serious Infections
Ear infections
|
13 Infections
|
|
Number of Non-serious Infections
Eye infections
|
4 Infections
|
|
Number of Non-serious Infections
Infections of the gastrointestinal tract
|
28 Infections
|
|
Number of Non-serious Infections
Infections of the genitourinary tract
|
14 Infections
|
|
Number of Non-serious Infections
Upper respiratory tract infections
|
90 Infections
|
|
Number of Non-serious Infections
Lower respiratory tract infections
|
16 Infections
|
|
Number of Non-serious Infections
Infections of the skin
|
5 Infections
|
|
Number of Non-serious Infections
Infections not elsewhere classified
|
14 Infections
|
SECONDARY outcome
Timeframe: Baseline to end of the study (up to 12 months)Population: Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.
Since infections were reported as adverse events, the time to resolution of an infection was the time from the start date of the infection adverse event to the end date of the infection adverse event.
Outcome measures
| Measure |
NewGam
n=51 Participants
Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
|
|---|---|
|
Time to Resolution of Serious and Other Infections
Serious infections
|
14.3 Days
Standard Deviation 7.63
|
|
Time to Resolution of Serious and Other Infections
Other infections
|
18.4 Days
Standard Deviation 34.82
|
SECONDARY outcome
Timeframe: Baseline to end of the study (up to 12 months)Population: Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.
The total percentage of participants treated with antibiotics, as well as, the percentage of participants treated with antibiotics therapeutically and prophylactically are reported.
Outcome measures
| Measure |
NewGam
n=51 Participants
Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
|
|---|---|
|
Percentage of Participants Treated With Antibiotics
|
82.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to end of the study (up to 12 months)Population: Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.
The number of antibiotic treatment episodes per person-year of treatment was calculated by the following formula: Total number of antibiotic treatment episodes / patient-years of NewGam treatment.
Outcome measures
| Measure |
NewGam
n=51 Participants
Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
|
|---|---|
|
Number of Antibiotic Treatment Episodes Per Person-year of Treatment
|
3.045 Treatment episodes/person/year
|
SECONDARY outcome
Timeframe: Baseline to end of the study (up to 12 months)Population: Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.
The number of antibiotic treatment days per person-year of treatment was calculated by the following formula: Total number of antibiotic treatment days / patient-years of NewGam treatment.
Outcome measures
| Measure |
NewGam
n=51 Participants
Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
|
|---|---|
|
Number of Antibiotic Treatment Days Per Person-year of Treatment
|
87.301 Treatment days/person/year
|
SECONDARY outcome
Timeframe: Baseline to end of the study (up to 12 months)Population: Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.
Outcome measures
| Measure |
NewGam
n=51 Participants
Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
|
|---|---|
|
Number of Participants Hospitalized Due to an Infection
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to end of the study (up to 12 months)Population: Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.
Outcome measures
| Measure |
NewGam
n=51 Participants
Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
|
|---|---|
|
Percentage of Participants With at Least 1 Episode of Fever
|
21.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to end of the study (up to 12 months)Population: Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.
Outcome measures
| Measure |
NewGam
n=51 Participants
Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
|
|---|---|
|
Percentage of Participants That Missed School or Work Due to an Infection
|
49.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to end of the study (up to 12 months)Population: Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.
The Quality of Life (QoL) questionnaire Child Health Questionnaire-Parent Form (CHQ-PF50) was completed by a parent or guardian in study participants \< 14 years of age. The CHQ-PF50 consists of 50 items organized into 15 subscales.The 15 subscales could be combined into 2 summary scores, physical and psychosocial. The calculated summary scores were transformed to a range of 0-100, where a higher score indicates more positive functioning or better health status. A positive change score indicates improvement.
Outcome measures
| Measure |
NewGam
n=17 Participants
Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
|
|---|---|
|
Changes in the Physical and Psychosocial Child Health Questionnaire-Parent Form Scores From Baseline to the End of the Study
Physical
|
2.77 Units on a scale
Standard Deviation 9.89
|
|
Changes in the Physical and Psychosocial Child Health Questionnaire-Parent Form Scores From Baseline to the End of the Study
Psychosocial
|
0.26 Units on a scale
Standard Deviation 7.19
|
SECONDARY outcome
Timeframe: Baseline to end of the study (up to 12 months)Population: Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.
The Quality of Life (QoL) questionnaire Short Form-36 Health Survey (SF-36-HS) was completed by participants ≥ 14 years of age. The SF-36-HS consists of 36 items organized into 8 subscales. The 8 subscales could be combined into 2 summary scores, physical and mental. The calculated summary scores were transformed to a range of 0-100, where a higher score indicates better health. A positive change score indicates improvement.
Outcome measures
| Measure |
NewGam
n=30 Participants
Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
|
|---|---|
|
Changes in the Physical and Mental Short Form-36 Health Survey Scores From Baseline to the End of the Study
Physical
|
-2.23 Units on a scale
Standard Deviation 9.96
|
|
Changes in the Physical and Mental Short Form-36 Health Survey Scores From Baseline to the End of the Study
Mental
|
2.59 Units on a scale
Standard Deviation 9.63
|
Adverse Events
NewGam
Serious adverse events
| Measure |
NewGam
n=51 participants at risk
Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
|
|---|---|
|
Metabolism and nutrition disorders
Gout
|
2.0%
1/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Infections and infestations
Pneumonia
|
2.0%
1/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
2.0%
1/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.0%
1/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Surgical and medical procedures
Septoplasty
|
2.0%
1/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
1/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
Other adverse events
| Measure |
NewGam
n=51 participants at risk
Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
|
|---|---|
|
Eye disorders
Conjunctivitis
|
5.9%
3/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
3/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.8%
6/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.8%
4/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
3/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Gastrointestinal disorders
Nausea
|
13.7%
7/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Gastrointestinal disorders
Vomiting
|
13.7%
7/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
General disorders
Fatigue
|
19.6%
10/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
General disorders
Pain
|
5.9%
3/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
General disorders
Pyrexia
|
21.6%
11/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Infections and infestations
Acute sinusitis
|
5.9%
3/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Infections and infestations
Bronchitis
|
15.7%
8/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Infections and infestations
Gastroenteritis
|
15.7%
8/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Infections and infestations
Gastroenteritis viral
|
5.9%
3/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Infections and infestations
Influenza
|
11.8%
6/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Infections and infestations
Nasopharyngitis
|
25.5%
13/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Infections and infestations
Oral herpes
|
5.9%
3/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Infections and infestations
Otitis media
|
13.7%
7/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Infections and infestations
Pharyngitis
|
11.8%
6/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Infections and infestations
Pharyngitis streptococcal
|
5.9%
3/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Infections and infestations
Rhinitis
|
5.9%
3/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Infections and infestations
Sinusitis
|
25.5%
13/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Infections and infestations
Upper respiratory tract infection
|
29.4%
15/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Infections and infestations
Viral infection
|
5.9%
3/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.9%
3/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
3/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.8%
4/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
3/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.8%
6/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Nervous system disorders
Headache
|
27.5%
14/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Nervous system disorders
Migraine
|
5.9%
3/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.7%
7/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.9%
3/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.8%
5/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.9%
3/51
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
|
Additional Information
Michael Eppolito, Director, Clinical Operations Immunology and ICU Medicine
Octapharma USA
Results disclosure agreements
- Principal investigator is a sponsor employee Octapharma agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Octapharma supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial. Octapharma also reserves the right to review data prior to publishing and provide comments/changes within a certain time period.
- Publication restrictions are in place
Restriction type: OTHER