Trial Outcomes & Findings for Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy) (NCT NCT02728752)

NCT ID: NCT02728752

Last Updated: 2021-12-23

Results Overview

Proportion of responders in the 2.0 g/kg Octagam 10% and placebo arms at Week 16 relative to baseline (Week 0). A responder being defined as a patient with an increase of ≥20 points on the Total Improvement Score (TIS, a scale from 0 to 100; 20-39 points being minimal improvement, 40-59 points being moderate improvement, and ≥60 points being major improvement

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 95 participants
• Primary outcome timeframe: At week 16
• Results posted on: 2021-12-23

Participant Flow

Participant milestones

Measure	Placebo Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.	Octagam10% Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
First Period STARTED	48	47
First Period COMPLETED	46	45
First Period NOT COMPLETED	2	2
Extension Period STARTED	46	45
Extension Period COMPLETED	35	34
Extension Period NOT COMPLETED	11	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy)

Baseline characteristics by cohort

Measure	Placebo n=48 Participants Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.	Octagam10% n=47 Participants Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.	Total n=95 Participants Total of all reporting groups
Age, Continuous	51.35 years STANDARD_DEVIATION 12.979 • n=5 Participants	54.04 years STANDARD_DEVIATION 13.838 • n=7 Participants	52.68 years STANDARD_DEVIATION 13.407 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	36 Participants n=7 Participants	71 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants	44 Participants n=7 Participants	87 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: At week 16

Proportion of responders in the 2.0 g/kg Octagam 10% and placebo arms at Week 16 relative to baseline (Week 0). A responder being defined as a patient with an increase of ≥20 points on the Total Improvement Score (TIS, a scale from 0 to 100; 20-39 points being minimal improvement, 40-59 points being moderate improvement, and ≥60 points being major improvement

Outcome measures

Measure	Placebo n=48 Participants Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.	Octagam10% n=47 Participants Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
Measure the Number of Patients Who Had an Increase of ≥20 Points on the Total Improvement Score (TIS)	21 Participants	37 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Only responders are displayed as the intent of the outcome measure is to present the proportion of responders. And patients not accounted for were non-responders.

The TIS (Total Improvement Score) is a scale from 0 to 100 that allows for the discrimination between minimal, moderate and major responders depending on their improvement in the combined 6 CSM: ≥20 to 39 points being minimal improvement, ≥40 to 59 points being moderate improvement, and ≥60 points being major improvement.

Primary: Total number of all patients who had at least minimal, moderate, or major response.

At Least Moderate: Number of patients who had moderate or major response. At Least Major: Number of patients who had a major response.

Outcome measures

Measure	Placebo n=48 Participants Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.	Octagam10% n=47 Participants Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
Proportion of TIS Responders by Improvement Category at Week 16 Primary	21 Participants	37 Participants
Proportion of TIS Responders by Improvement Category at Week 16 At least moderate improvement	11 Participants	32 Participants
Proportion of TIS Responders by Improvement Category at Week 16 At least major improvement	4 Participants	15 Participants

SECONDARY outcome

Timeframe: 40 weeks

Population: Only responders are displayed as the intent of the outcome measure is to present the proportion of responders. And patients not accounted for were non-responders.

The TIS (Total Improvement Score) is a scale from 0 to 100 that allows for the discrimination between minimal, moderate and major responders depending on their improvement in the combined 6 CSM: ≥20 to 39 points being minimal improvement, ≥40 to 59 points being moderate improvement, and ≥60 points being major improvement.

At Least Minimal: Total number of all patients who had minimal, moderate, or major response.

At Least Moderate: Number of patients who had moderate or major response. At Least Major: Number of patients who had a major response.

Outcome measures

Measure	Placebo n=46 Participants Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.	Octagam10% n=45 Participants Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
Proportion of TIS Responders by Improvement Category at Week 40 At least minimal improvement	32 Participants	32 Participants
Proportion of TIS Responders by Improvement Category at Week 40 At least major improvement	14 Participants	17 Participants
Proportion of TIS Responders by Improvement Category at Week 40 At least moderate improvement	28 Participants	26 Participants

SECONDARY outcome

Timeframe: First 16 weeks

The modified CDASI has 3 activity measures (erythema, scale, and erosion/ulceration) and 2 damage measures (poikiloderma and calcinosis) which are assessed over 15 body areas. In addition, Gottron's papules on the hands are evaluated both for activity and damage. Lastly, the activity of periungual changes and alopecia is assessed.

Absence of skin lesions as described above is scored with "0" for each of the above described areas. Skin lesion will be scored with at least "1" (present), some lesions will be graded from "1" (less severe) to "2" (severe); others with "1", "2" or "3". For the total activity score as well as for the total damage score the sub-scores will be added up. The score for total activity ranges from 0 to 100, for total damage from 0 to 32 points. Higher scores indicate greater disease activity or greater disease damage respectively.

Outcome measures

Measure	Placebo n=43 Participants Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.	Octagam10% n=45 Participants Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
Mean Change From Baseline (Week 0) to End of First Period (Week 16) in the Modified Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Total Activity Score	-1.16 units on a scale Standard Deviation 7.000	-9.36 units on a scale Standard Deviation 10.542
Mean Change From Baseline (Week 0) to End of First Period (Week 16) in the Modified Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Total Damage Score	-0.02 units on a scale Standard Deviation 0.771	-0.67 units on a scale Standard Deviation 1.871

SECONDARY outcome

Timeframe: From week 16 to Week 40

The modified CDASI has 3 activity measures (erythema, scale, and erosion/ulceration) and 2 damage measures (poikiloderma and calcinosis) which are assessed over 15 body areas. In addition, Gottron's papules on the hands are evaluated both for activity and damage. Lastly, the activity of periungual changes and alopecia is assessed

Absence of skin lesions as described above is scored with "0" for each of the above described areas. Skin lesion will be scored with at least "1" (present), some lesions will be graded from "1" (less severe) to "2" (severe); others with "1", "2" or "3". For the total activity score as well as for the total damage score the sub-scores will be added up. The score for total activity ranges from 0 to 100, for total damage from 0 to 32 points. Higher scores indicate greater disease activity or greater disease damage respectively.

Outcome measures

Measure	Placebo n=33 Participants Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.	Octagam10% n=34 Participants Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
Mean Change From End of First Period (Week 16) to End of Extension Period (Week 40) in the Modified Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Total Damage Score	-0.24 units on a scale Standard Deviation 0.969	0.26 units on a scale Standard Deviation 2.220
Mean Change From End of First Period (Week 16) to End of Extension Period (Week 40) in the Modified Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Total Activity Score	-8.52 units on a scale Standard Deviation 11.344	-1.79 units on a scale Standard Deviation 4.169

SECONDARY outcome

Timeframe: 40 weeks

The modified CDASI has 3 activity measures (erythema, scale, and erosion/ulceration) and 2 damage measures (poikiloderma and calcinosis) which are assessed over 15 body areas. In addition, Gottron's papules on the hands are evaluated both for activity and damage. Lastly, the activity of periungual changes and alopecia is assessed.

Absence of skin lesions as described above is scored with "0" for each of the above described areas. Skin lesion will be scored with at least "1" (present), some lesions will be graded from "1" (less severe) to "2" (severe); others with "1", "2" or "3". For the total activity score as well as for the total damage score the sub-scores will be added up. The score for total activity ranges from 0 to 100, for total damage from 0 to 32 points. Higher scores indicate greater disease activity or greater disease damage respectively.

Outcome measures

Measure	Placebo n=35 Participants Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.	Octagam10% n=34 Participants Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
Mean Change From Baseline (Week 0) to End of Extension Period (Week 40) in the Modified Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Total Activity Score	-10.44 units on a scale Standard Deviation 10.034	-10.03 units on a scale Standard Deviation 8.995
Mean Change From Baseline (Week 0) to End of Extension Period (Week 40) in the Modified Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Total Damage Score	-0.26 units on a scale Standard Deviation 1.197	-0.38 units on a scale Standard Deviation 2.523

SECONDARY outcome

Timeframe: From start of the trial till Week 40

Population: Numbers of patients analyzed different due to patient discontinuations through study.

The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.

SF-36 scores ranging from 0 to 100. 0 represented the lowest possible score (worst health state) and 100 represented the highest possible score (best health state), with scores in between representing the percentages of the total possible score achieved by respondents on a given scale.

Outcome measures

Measure	Placebo n=43 Participants Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.	Octagam10% n=43 Participants Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: SF-36v2 Health Survey Baseline to Week 16	2.27 units on a scale Standard Deviation 4.598	7.06 units on a scale Standard Deviation 8.220
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: SF-36v2 Health Survey Baseline to Week 40	6.65 units on a scale Standard Deviation 8.258	8.77 units on a scale Standard Deviation 10.930

SECONDARY outcome

Timeframe: From start of the trial till Week 40

Population: Different numbers of patients analyzed in each group due to patient discontinuation.

10 cm VAS assessing global disease activity from "No evidence of disease activity" to "Extremely active or severe disease activity"; Disease Activity being defined as potentially reversible pathology or physiology resulting from the myositis). Assessment completed by physician. 0 is lowest score and 10 is highest score. Higher score associated with worse outcome.

Outcome measures

Measure	Placebo n=43 Participants Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.	Octagam10% n=45 Participants Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Physician's Global Disease Activity Baseline to Week 40	-2.93 score on a scale Standard Deviation 1.888	-3.06 score on a scale Standard Deviation 1.817
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Physician's Global Disease Activity Baseline to Week 16	-0.60 score on a scale Standard Deviation 1.815	-2.39 score on a scale Standard Deviation 1.987

SECONDARY outcome

Timeframe: From start of the trial till Week 40

Population: Different numbers of patients analyzed in each group due to patient discontinuation.

Patient's Global Disease Activity (10cm VAS assessing the overall activity of the patient's disease today from "No evidence of disease activity" to "Extremely active or severe disease activity", Disease Activity being active inflammation in the patient's muscles, skin, joints, intestines, heart, lungs or other parts of the body, which can improve when treated with medicines). 0 is lowest score and 10 is highest score. Higher score associated with worse outcome.

Outcome measures

Measure	Placebo n=43 Participants Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.	Octagam10% n=45 Participants Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: Patient Global Disease Activity Baseline to Week 40	-2.77 score on a scale Standard Deviation 2.133	-2.71 score on a scale Standard Deviation 2.651
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: Patient Global Disease Activity Baseline to Week 16	-1.11 score on a scale Standard Deviation 2.094	-2.19 score on a scale Standard Deviation 2.276

SECONDARY outcome

Timeframe: From start of the trial till Week 40

Population: Different numbers of patients analyzed in each group due to patient discontinuation.

Manual Muscle Testing - MMT-8; a set of 8 designated muscles tested bilaterally [potential score 0 - 150]. Higher score associated with better outcome.

Outcome measures

Measure	Placebo n=43 Participants Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.	Octagam10% n=45 Participants Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: MMT-8 Baseline to Week 16	3.21 score on a scale Standard Deviation 9.390	14.38 score on a scale Standard Deviation 14.581
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: MMT-8 Baseline to Week 40	12.00 score on a scale Standard Deviation 7.491	20.09 score on a scale Standard Deviation 14.486

SECONDARY outcome

Timeframe: From start of the trial till Week 40

Population: Different numbers of patients analyzed in each group due to patient discontinuation.

Health Assessment Questionnaire (HAQ); a generic rather than a disease-specific instrument; comprised of 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 [without any difficulty] to 3 [unable to do]. For each section the score given to that section is the worst score within the section. The 8 scores of the 8 sections are summed and divided by 8). Assessment completed by patients. Lowest score 0 highest score 24. Higher score associated with worse outcome.

Outcome measures

Measure	Placebo n=43 Participants Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.	Octagam10% n=45 Participants Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: Health Assessment Questionnaire Baseline to Week 16	-0.16 score on a scale Standard Deviation 0.366	-0.56 score on a scale Standard Deviation 0.590
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: Health Assessment Questionnaire Baseline to Week 40	-0.54 score on a scale Standard Deviation 0.524	-0.66 score on a scale Standard Deviation 0.805

SECONDARY outcome

Timeframe: From start of the trial till Week 40

Population: Different numbers of patients analyzed in each group due to patient discontinuation.

Outcome measures

Measure	Placebo n=43 Participants Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.	Octagam10% n=42 Participants Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Enzymes (Alanine Aminotransferase) Baseline to Week 16	-4.47 U/L Standard Deviation 29.796	-8.52 U/L Standard Deviation 18.474
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Enzymes (Alanine Aminotransferase) Baseline to Week 40	-4.06 U/L Standard Deviation 14.787	-7.15 U/L Standard Deviation 18.480

SECONDARY outcome

Timeframe: From start of the trial till Week 40

Population: Different numbers of patients analyzed in each group due to patient discontinuation.

Outcome measures

Measure	Placebo n=43 Participants Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.	Octagam10% n=44 Participants Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Enzymes (Aspartate Aminotransferase) Baseline to Week 16	-3.07 U/L Standard Deviation 31.317	-7.82 U/L Standard Deviation 26.139
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Enzymes (Aspartate Aminotransferase) Baseline to Week 40	-2.20 U/L Standard Deviation 16.421	-7.76 U/L Standard Deviation 26.431

SECONDARY outcome

Timeframe: From start of the trial till Week 40

Population: Different numbers of patients analyzed in each group due to patient discontinuation.

Outcome measures

Measure	Placebo n=43 Participants Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.	Octagam10% n=45 Participants Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Enzymes (Lactate Dehydrogenase) Baseline to Week 16	-19.79 U/L Standard Deviation 142.012	-11.04 U/L Standard Deviation 165.252
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Enzymes (Lactate Dehydrogenase) Baseline to Week 40	-33.43 U/L Standard Deviation 63.651	-59.21 U/L Standard Deviation 92.801

SECONDARY outcome

Timeframe: From start of the trial till Week 40

Population: Different numbers of patients analyzed in each group due to patient discontinuation.

Outcome measures

Measure	Placebo n=41 Participants Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.	Octagam10% n=42 Participants Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Enzymes (Aldolase) Baseline to Week 40	-0.59 U/L Standard Deviation 7.839	-1.48 U/L Standard Deviation 3.644
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Enzymes (Aldolase) Baseline to Week 16	-2.51 U/L Standard Deviation 12.077	-0.48 U/L Standard Deviation 7.743

SECONDARY outcome

Timeframe: From start of the trial till Week 40

Population: Different numbers of patients analyzed in each group due to patient discontinuation.

Outcome measures

Measure	Placebo n=43 Participants Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.	Octagam10% n=44 Participants Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Enzymes (Creatine Kinase) Baseline to Week 16	-352.79 U/L Standard Deviation 2141.534	-169.20 U/L Standard Deviation 434.224
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Enzymes (Creatine Kinase) Baseline to Week 40	-56.54 U/L Standard Deviation 556.928	-169.38 U/L Standard Deviation 449.210

SECONDARY outcome

Timeframe: From start of the trial until Week 40

Population: Different numbers of patients analyzed in each group due to patient discontinuation.

10 cm VAS assessing extra-muscular activity from "No evidence of disease activity" to "Extremely active or severe disease activity". It encompasses an overall evaluation for the disease activity in all the extramuscular organ systems and excludes muscle disease activity. Assessment completed by physician. 0 is lowest score and 10 is highest score. Higher score associated with worse outcome.

Outcome measures

Measure	Placebo n=43 Participants Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.	Octagam10% n=45 Participants Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: Extra-muscular Activity Baseline to Week 16	-0.94 units on a scale Standard Deviation 2.287	-2.18 units on a scale Standard Deviation 2.134
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: Extra-muscular Activity Baseline to Week 40	-2.64 units on a scale Standard Deviation 2.092	-2.67 units on a scale Standard Deviation 2.061

SECONDARY outcome

Timeframe: Up to 40 weeks

Population: Different numbers of patients analyzed in each group due to patient discontinuation.

The TIS (Total Improvement Score) is a scale from 0 to 100 that allows for the discrimination between minimal, moderate and major responders depending on their improvement in the combined 6 CSM: ≥20 to 39 points being minimal improvement, ≥40 to 59 points being moderate improvement, and ≥60 points being major improvement.

Outcome measures

Measure	Placebo n=43 Participants Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.	Octagam10% n=45 Participants Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
Mean TIS From Baseline (Week 0) to End of First Period (Week 16) and From Baseline (Week 0) to End of Extension Period (Week 40) Week 40	51.07 units on a scale Standard Deviation 18.314	55.44 units on a scale Standard Deviation 21.712
Mean TIS From Baseline (Week 0) to End of First Period (Week 16) and From Baseline (Week 0) to End of Extension Period (Week 40) Week 16	21.57 units on a scale Standard Deviation 20.185	48.44 units on a scale Standard Deviation 24.444

SECONDARY outcome

Timeframe: Up to 40 weeks

Population: Number of participants based on number of responders. 95% confidence interval not available for all measurements.

When interpreting these time to event evaluations, one has to keep in mind that eventually all patients were treated with octagam 10%, so that differences in time to response for the Overall Period reflect this delayed start of treatment rather than the true difference between treatment with octagam 10% and placebo.

Outcome measures

Measure	Placebo n=48 Participants Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.	Octagam10% n=47 Participants Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
Time to Minimal, Moderate and Major Improvement in TIS Time to Minimal Improvement - First Period	115.0 days Interval 84.0 to Insufficient number of participants with events	35.0 days Interval 29.0 to 58.0
Time to Minimal, Moderate and Major Improvement in TIS Time to Major Improvement - First Period	NA days Insufficient number of participants with events	NA days Interval 115.0 to Insufficient number of participants with events
Time to Minimal, Moderate and Major Improvement in TIS Time to Minimal Improvement - From Start of First Treatment in Overall Period	114.0 days Interval 84.0 to 195.0	35.0 days Interval 29.0 to 58.0
Time to Minimal, Moderate and Major Improvement in TIS Time to Moderate Improvement - First Period	NA days Insufficient number of participants with events	85.0 days Interval 58.0 to 113.0
Time to Minimal, Moderate and Major Improvement in TIS Time to Moderate Improvement - From Start of First Treatment in Overall Period	197.0 days Interval 195.0 to 282.0	85.0 days Interval 58.0 to 113.0
Time to Minimal, Moderate and Major Improvement in TIS Time to Major Improvement - From Start of First Treatment in Overall Period	283.0 days Interval 203.0 to Insufficient number of participants with events	283.0 days Interval 197.0 to 290.0

SECONDARY outcome

Timeframe: Up to 40 weeks

Population: All patients analyzed and only those that had confirmed deterioration are presented.

Confirmed deterioration is defined as disease worsening on 2 consecutive visits. Worsening criteria are defined as either Physician's Global Disease Activity worsening ≥2cm and Manual Muscle Testing worsening ≥20% or Extra-muscular Activity worsening ≥2cm or any 3 of the following scores worsening by ≥30%: Physician's Global Disease Activity, Manual Muscle Test, Extra-muscular Activity, Patient's Global Disease Activity or Health Assessment Questionnaire.

Outcome measures

Measure	Placebo n=3 Participants Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.	Octagam10% n=1 Participants Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
Time to Confirmed Deterioration in the First Period and Overall First Period	58 days Interval 57.0 to 117.0	—
Time to Confirmed Deterioration in the First Period and Overall Overall Period	58 days Interval 57.0 to 117.0	142 days Single participant

Adverse Events

First Period Placebo

Serious events: 2 serious events

Other events: 28 other events

Deaths: 0 deaths

Overall Period Octagam

Serious events: 14 serious events

Other events: 84 other events

Deaths: 0 deaths

Serious adverse events

Measure	First Period Placebo n=48 participants at risk Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but with not further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.	Overall Period Octagam n=95 participants at risk Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
Cardiac disorders Sinus tachycardia	2.1% 1/48 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Cardiac disorders Ventricular extrasystoles	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Infections and infestations Sepsis	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	2.1% 2/95 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Infections and infestations Tropical spastic paresis	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	3.2% 3/95 • Number of events 3 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Vascular disorders Hypertension	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Cardiac disorders Cardiac failure congestive	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
General disorders Condition aggravated	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	2.1% 2/95 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Infections and infestations Atypical pneumonia	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Infections and infestations Escherichia bacteraemia	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Infections and infestations Pneumonia	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Nervous system disorders Cerebral infarction	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Nervous system disorders Cerebrovascular accident	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Nervous system disorders Hypoaesthesia	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Nervous system disorders Loss of consciousness	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Vascular disorders Deep vein thrombosis	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Renal and urinary disorders Acute kidney injury	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.

Other adverse events

Measure	First Period Placebo n=48 participants at risk Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but with not further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period.	Overall Period Octagam n=95 participants at risk Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
Blood and lymphatic system disorders Lymphopenia	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	2.1% 2/95 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Cardiac disorders Atrioventricular block first degree	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Cardiac disorders Bradycardia	4.2% 2/48 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Cardiac disorders Mitral valve calcification	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Cardiac disorders Palpitations	4.2% 2/48 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Cardiac disorders Sinus tachycardia	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Cardiac disorders Tachycardia	4.2% 2/48 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	5.3% 5/95 • Number of events 6 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Cardiac disorders Ventricular extrasystoles	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Cardiac disorders Pulmonary valve incompetence	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Ear and labyrinth disorders Deafness	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Ear and labyrinth disorders Vertigo	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	2.1% 2/95 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Endocrine disorders Adrenal insufficiency	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Eye disorders Cataract	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Eye disorders Conjunctival haemorrhage	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Eye disorders Eye pruritus	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Eye disorders Ocular hyperaemia	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Eye disorders Vision blurred	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	2.1% 2/95 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Gastrointestinal disorders Abdominal pain	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	2.1% 2/95 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	2.1% 2/95 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Gastrointestinal disorders Constipation	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	5.3% 5/95 • Number of events 5 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Gastrointestinal disorders Diarrhoea	4.2% 2/48 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	4.2% 4/95 • Number of events 7 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Gastrointestinal disorders Dry mouth	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Gastrointestinal disorders Faecal incontinence	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Gastrointestinal disorders Haemorrhoids	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Gastrointestinal disorders Nausea	4.2% 2/48 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	18.9% 18/95 • Number of events 30 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Gastrointestinal disorders Oral pain	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Gastrointestinal disorders Vomiting	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	9.5% 9/95 • Number of events 12 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
General disorders Asthenia	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	3.2% 3/95 • Number of events 7 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
General disorders Catheter site erythema	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
General disorders Chest discomfort	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	2.1% 2/95 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
General disorders Chest pain	6.2% 3/48 • Number of events 3 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	3.2% 3/95 • Number of events 3 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
General disorders Chills	2.1% 1/48 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	7.4% 7/95 • Number of events 12 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
General disorders Condition aggravated	18.8% 9/48 • Number of events 22 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	9.5% 9/95 • Number of events 13 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
General disorders Extravastation	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	2.1% 2/95 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
General disorders Fatigue	8.3% 4/48 • Number of events 4 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	5.3% 5/95 • Number of events 6 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
General disorders Feeling cold	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
General disorders Infusion site bruising	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
General disorders Injection site pain	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	2.1% 2/95 • Number of events 4 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
General disorders Malaise	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
General disorders Oedema peripheral	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	3.2% 3/95 • Number of events 3 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
General disorders Pain	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	2.1% 2/95 • Number of events 3 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
General disorders Peripheral swelling	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	3.2% 3/95 • Number of events 3 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
General disorders Pyrexia	6.2% 3/48 • Number of events 3 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	17.9% 17/95 • Number of events 26 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Hepatobiliary disorders Hepatic steatosis	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Infections and infestations Asymptomatic bacteriuria	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Infections and infestations Bronchitis	4.2% 2/48 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	3.2% 3/95 • Number of events 3 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Infections and infestations Cellulitis	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Infections and infestations Conjunctivitis	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Infections and infestations Gastroenteritis viral	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Infections and infestations Influenza	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Infections and infestations Localised infection	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Infections and infestations Nasopharyngitis	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	6.3% 6/95 • Number of events 8 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Infections and infestations Rash pustular	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Infections and infestations Tooth abscess	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Infections and infestations Upper respiratory tract infection	4.2% 2/48 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	3.2% 3/95 • Number of events 4 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Injury, poisoning and procedural complications Contusion	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	2.1% 2/95 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Injury, poisoning and procedural complications Fall	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Injury, poisoning and procedural complications Tendon rupture	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Injury, poisoning and procedural complications Overdose	4.2% 2/48 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Investigations Alanine aminotransferase increased	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Investigations Aspartate aminotransferase increased	4.2% 2/48 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Investigations Blood glucose increased	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Investigations Blood lactate dehydrogenase increased	4.2% 2/48 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Investigations Blood potassium increased	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Investigations Blood pressure decreased	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Investigations Blood pressure diastolic increased	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Investigations Blood pressure increased	6.2% 3/48 • Number of events 4 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	4.2% 4/95 • Number of events 8 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Investigations Blood pressure systolic increased	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	3.2% 3/95 • Number of events 3 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Investigations Blood urea increased	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Investigations Body temperature increased	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	5.3% 5/95 • Number of events 8 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Investigations Coombs test positive	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	5.3% 5/95 • Number of events 5 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Investigations Haemoglobin decreased	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	4.2% 4/95 • Number of events 5 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Investigations Lymphocyte count decreased	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Investigations Neutrophil count decreased	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Investigations Weight decreased	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Investigations White blood cell count decreased	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	2.1% 2/95 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Musculoskeletal and connective tissue disorders Arthralgia	8.3% 4/48 • Number of events 5 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	7.4% 7/95 • Number of events 8 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Musculoskeletal and connective tissue disorders Back pain	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	4.2% 4/95 • Number of events 6 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	2.1% 2/95 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Musculoskeletal and connective tissue disorders Joint swelling	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	3.2% 3/95 • Number of events 3 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	9.5% 9/95 • Number of events 12 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	2.1% 2/95 • Number of events 3 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	2.1% 2/95 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Nervous system disorders Basilar artery stenosis	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Nervous system disorders Dizziness	6.2% 3/48 • Number of events 3 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	5.3% 5/95 • Number of events 6 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Nervous system disorders Headache	8.3% 4/48 • Number of events 10 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	48.4% 46/95 • Number of events 102 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Nervous system disorders Hypoaesthesia	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Nervous system disorders Paraesthesia	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Nervous system disorders Somnolence	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Nervous system disorders Tremor	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Psychiatric disorders Insomnia	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Renal and urinary disorders Acute kidney injury	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Renal and urinary disorders Urinary retention	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Renal and urinary disorders Urine abnormality	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 7 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Respiratory, thoracic and mediastinal disorders Dysphonia	4.2% 2/48 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	5.3% 5/95 • Number of events 5 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	2.1% 2/95 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Respiratory, thoracic and mediastinal disorders Throat irritation	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Skin and subcutaneous tissue disorders Diffuse alopecia	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Skin and subcutaneous tissue disorders Erythema	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Skin and subcutaneous tissue disorders Night sweats	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Skin and subcutaneous tissue disorders Pruritus	4.2% 2/48 • Number of events 3 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Skin and subcutaneous tissue disorders Rash	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	6.3% 6/95 • Number of events 6 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Skin and subcutaneous tissue disorders Telangiectasia	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Vascular disorders Deep vein thrombosis	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Vascular disorders Essential hypertension	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	0.00% 0/95 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Vascular disorders Hot flush	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Vascular disorders Hypertension	6.2% 3/48 • Number of events 3 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	5.3% 5/95 • Number of events 6 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Vascular disorders Hypotension	2.1% 1/48 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Blood and lymphatic system disorders Anaemia	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	3.2% 3/95 • Number of events 3 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Blood and lymphatic system disorders Haemolysis	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Vascular disorders Peripheral coldness	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Endocrine disorders Hyperthyroidism	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Eye disorders Eye disorder	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Gastrointestinal disorders Dysphagia	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	2.1% 2/95 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Gastrointestinal disorders Gastritis	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
General disorders Influenza like illness	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
General disorders Infusion site extravasation	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
General disorders Infusion site pain	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
General disorders Infusion site reaction	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
General disorders Infusion site swelling	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
General disorders Injection site erythema	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
General disorders Injection site induration	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
General disorders Local swelling	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
General disorders Nodule	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Hepatobiliary disorders Cholecystitis	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Hepatobiliary disorders Cholelithiasis	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Immune system disorders Hypersensitivity	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Infections and infestations Cystitis	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	2.1% 2/95 • Number of events 3 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Infections and infestations Diverticulitis	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Infections and infestations Herpes zoster	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Infections and infestations Lyme disease	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Infections and infestations Pharyngitis	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Infections and infestations Pneumonia	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Infections and infestations Pyelonephritis acute	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Infections and infestations Sinusitis	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Infections and infestations Tooth infection	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Infections and infestations Tracheitis	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Infections and infestations Urinary tract infection	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	2.1% 2/95 • Number of events 3 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Injury, poisoning and procedural complications Joint injury	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Investigations Blood creatinine increased	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	2.1% 2/95 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Investigations Cardiac murmur	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Investigations Free haemoglobin present	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Investigations Heart rate increased	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Investigations Muscle enzyme increased	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	2.1% 2/95 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	2.1% 2/95 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Metabolism and nutrition disorders Malnutrition	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	2.1% 2/95 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Musculoskeletal and connective tissue disorders Muscle fatigue	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	6.3% 6/95 • Number of events 9 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Psychiatric disorders Depression	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Renal and urinary disorders Dysuria	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Renal and urinary disorders Pollakiuria	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	4.2% 4/95 • Number of events 4 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Skin and subcutaneous tissue disorders Poikiloderma	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Skin and subcutaneous tissue disorders Skin burning sensation	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 2 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Skin and subcutaneous tissue disorders Urticaria contact	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Social circumstances Menopause	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Social circumstances Postmenopause	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Vascular disorders Brachiocephalic arteriosclerosis	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
General disorders Infusion site erythema	0.00% 0/48 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.	1.1% 1/95 • Number of events 1 • 40 weeks Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.

Additional Information

Mikaela Raymond

CRMG

Phone: 866-337-1868

Email: ctgov@clinicalresearchmgt.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place