Trial Outcomes & Findings for A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) (NCT NCT02549170)

Results Overview

Relapse rate is defined as the percentage of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of \>=1 point relative to the pre- subcutaneous (SC) treatment baseline score in 2 consecutive adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

138 participants

Primary outcome timeframe

Week 32 End of Epoch 1 Treatment (EOET1)/Unscheduled relapse visit assessment (UV)/Early Termination (ET)

Results posted on

2023-05-24

Participant Flow

Participants took part in the study at 54 investigative sites from December 15, 2015 to February 23, 2022. Participants with a diagnosis of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) were enrolled in this study.

Participants received one of the two treatments either HYQVIA/HyQvia or the 0.25% albumin placebo solution with rHuPH20 (Recombinant Human Hyaluronidase) for 6 months or until relapse in Epoch 1. Participants who relapsed during Epoch 1 received GGL/KIOVIG (participants at non-US sites) or GAMUNEX-C (participants at US sites only) in Epoch 2. A total of 138 participants were enrolled out of which 132 participants received atleast one dose of study drug.

Participant milestones

Participant milestones
Measure	Epoch 1: Placebo With rHuPH20 Participants received rHuPH20 80 U/10 mL solution, followed by SC placebo infusion at matching infusion volume as per the participant's pre-randomization monthly equivalent IG dose when administered every 2, 3, or 4 weeks for 31.54 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG Participants who were enrolled to receive placebo with rHuPH20 and achieved chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg bi-weekly (BW), followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG Participants who were enrolled to receive HYQVIA/HyQvia (rHuPH20) and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 28.67 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 1: Day 1 to Approximately 32 Weeks STARTED	70	62	0	0	0
Epoch 1: Day 1 to Approximately 32 Weeks COMPLETED	46	48	0	0	0
Epoch 1: Day 1 to Approximately 32 Weeks NOT COMPLETED	24	14	0	0	0
Epoch 2: Up to Approximately Week 61 STARTED	0	0	16	4	1
Epoch 2: Up to Approximately Week 61 COMPLETED	0	0	16	4	1
Epoch 2: Up to Approximately Week 61 NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Epoch 1: Placebo With rHuPH20 Participants received rHuPH20 80 U/10 mL solution, followed by SC placebo infusion at matching infusion volume as per the participant's pre-randomization monthly equivalent IG dose when administered every 2, 3, or 4 weeks for 31.54 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.
Epoch 1: Day 1 to Approximately 32 Weeks Relapsed and Entered Epoch 2 (E2)	17	4
Epoch 1: Day 1 to Approximately 32 Weeks Relapsed and did not Enter E2	5	2
Epoch 1: Day 1 to Approximately 32 Weeks Did not Relapse;Ended Treatment (ET) From Epoch1	2	8

Baseline Characteristics

A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Epoch 1: Placebo With rHuPH20 n=70 Participants Participants received rHuPH20 80 U/10 mL solution, followed by SC placebo infusion at matching infusion volume as per the participant's pre-randomization monthly equivalent IG dose when administered every 2, 3, or 4 weeks for 31.54 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=62 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Total n=132 Participants Total of all reporting groups
Age, Continuous	53.9 years STANDARD_DEVIATION 13.42 • n=5 Participants	55.0 years STANDARD_DEVIATION 14.26 • n=7 Participants	54.4 years STANDARD_DEVIATION 13.78 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	26 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	36 Participants n=7 Participants	74 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	9 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=5 Participants	47 Participants n=7 Participants	93 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	64 Participants n=5 Participants	58 Participants n=7 Participants	122 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	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 32 End of Epoch 1 Treatment (EOET1)/Unscheduled relapse visit assessment (UV)/Early Termination (ET)

Population: MITT analysis set included all randomized participants who received any double-blind study medication.

Relapse rate is defined as the percentage of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of \>=1 point relative to the pre- subcutaneous (SC) treatment baseline score in 2 consecutive adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=70 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=62 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 1: Relapse Rate	31.4 percentage of participants Interval 21.76 to 43.03	9.7 percentage of participants Interval 4.51 to 19.55	—

PRIMARY outcome

Timeframe: Up to 6 Months post-Epoch 1 (End of Epoch 2 Treatment [EOE2T])/Unscheduled visit assessment (UV)/Early Termination

Population: E1:Placebo Relapse / E2:GGL/KIOVIG Set included a subset of participants who had a relapse while on placebo in Epoch 1, entered Epoch 2, and were treated with GAMMAGARD LIQUID/KIOVIG in Epoch 2.

Responder rate is defined as clinically meaningful improvement in functional ability defined as a decrease of \>=1 point in the adjusted INCAT disability score at the completion of the intravenous (IV) treatment period \[6 months\] or at the last study visit of the IV treatment period, relative to the pre-IV treatment baseline score.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=16 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 2: Responder Rate	100 percentage of participants Interval 80.64 to 100.0	—	—

SECONDARY outcome

Timeframe: Week 32 (EOET1)/UV/ET

Population: MITT analysis set included all randomized participants who received any double-blind study medication. Overall number of participants analyzed is the number of participants available with data.

Defined as one or more of the following: an increase of \>=1 point relative to the pre-subcutaneous (SC) treatment baseline score in 2 consecutive adjusted Inflammatory Neuropathy Cause and Treatment disability scale (INCAT) scores; who experience CIDP worsening (defined as a \>=8 kilo Pascal (kPa) decrease in the hand grip strength in the more affected hand); \>=4 points decrease in raw Rasch-built Overall Disability Scale (R-ODS) relative to the pre-SC treatment baseline score (at the time of withdrawal from the SC treatment period). Participants are rounded off to nearest single decimal point.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=68 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=56 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 1: Percentage of Participants Who Experience a Worsening of Functional Disability	54.4 percentage of participants Interval 42.66 to 65.7	37.5 percentage of participants Interval 26.01 to 50.59	—

SECONDARY outcome

Timeframe: Week 32 (EOET1)/UV/ET

Population: MITT analysis set included all randomized participants who received any double-blind study medication.

Time to relapse is defined as time from the date of the first SC administration of HYQVIA/HyQvia or placebo with rHuPH20 to the date of relapse. Participants who did not relapse were censored at their end of study.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=70 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=62 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Time to Relapse	NA days Interval 20.0 to 221.0 Data for median was not estimable as less than 50% of the participants had event.	NA days Interval 7.0 to 217.0 Data for median was not estimable as less than 50% of the participants had event.	—

SECONDARY outcome

Timeframe: Pre-subcutaneous (SC) treatment baseline, end of Epoch 1 treatment (approximately 7.3 months)

Population: MITT analysis set included all randomized participants who received any double-blind study medication. Overall number of participants analyzed is the number of participants available with data.

The Rasch-Built Overall Disability Scale (R-ODS) is a participant self-reported, linearly-weighted overall disability scale that was specifically designed to capture activity and social participation limitations in participant with immune-mediated peripheral neuropathies including CIDP. The R-ODS is comprised of 24 items for which participants are asked to rate their functioning (i.e, no difficulty, some difficulty, or could not do) related to a variety of everyday tasks at the moment of completion. The centile metric R-ODS score range is 0 to 100. Higher scores indicate better condition. The centile metric R-ODS score was used in the ANCOVA analysis. ANCOVA was used for the analysis.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=63 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=59 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 1: Change From Pre-Subcutaneous (SC) Treatment Baseline in Rasch-built Overall Disability Scale (R-ODS)	-6.1 score on a scale Standard Error 1.64	-0.9 score on a scale Standard Error 1.69	—

SECONDARY outcome

Timeframe: Week 32 (EOET1)/UV/ET

Population: Epoch 1 safety analysis set included all participants who received any study treatment.

An AE is defined as any untoward medical occurrence in participant administered an Investigational Product (IP) that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=70 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=62 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 1: Number of Participants Experiencing Any Treatment-Emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs), Regardless of Causality Any TEAE	40 Participants	49 Participants	—
Epoch 1: Number of Participants Experiencing Any Treatment-Emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs), Regardless of Causality Any Serious TEAE	5 Participants	2 Participants	—

SECONDARY outcome

Timeframe: Week 32 (EOET1)/UV/ET

Population: Epoch 1 safety analysis set included all participants who received any study treatment.

AE=any untoward medical occurrence in participant administered IP. AE can therefore be any unfavorable and unintended sign (e.g.,abnormal laboratory finding), symptom (e.g.,rash, pain, discomfort, fever, dizziness, etc.), disease (e.g.,peritonitis,bacteremia,etc.), outcome of death temporally associated with use of IP,considered causally related to the IP. SAE=untoward medical occurrence that at any dose meets following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization/results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is congenital anomaly/birth defect, is medically important event, thromboembolic events, hemolytic anemia. Non-SAE=AE not meeting this criteria. AE recorded by investigator as possibly/probably related to IP is considered related AE, any AE recorded as unlikely/not related is considered unrelated AE.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=70 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=62 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 1: Number of Participants Experiencing Causally Related Serious and/or Non-Serious Adverse Events (SAEs and/or AEs) Any IP-related TEAE	19 Participants	38 Participants	—
Epoch 1: Number of Participants Experiencing Causally Related Serious and/or Non-Serious Adverse Events (SAEs and/or AEs) Any Serious IP-related TEAE	5 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Week 32 (EOET1)/UV/ET

Population: Epoch 1 safety analysis set included all participants who received any study treatment.

An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=70 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=62 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 1: Number of Participants With Serious and/or Non-serious Adverse Reactions (ARs) Plus Suspected ARs All AR/SAR	27 Participants	41 Participants	—
Epoch 1: Number of Participants With Serious and/or Non-serious Adverse Reactions (ARs) Plus Suspected ARs Serious AR/SAR	5 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Week 32 (EOET1)/UV/ET

Population: Epoch 1 safety analysis set included all participants who received any study treatment. Participants can have more than one adverse event.

AE: any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. SAE: an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria. Participants can have more than one adverse event.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=70 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=62 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 1: Number of Treatment-emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions Regardless of Causality Non-serious AEs	144 events in participants	340 events in participants	—
Epoch 1: Number of Treatment-emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions Regardless of Causality Serious AEs	5 events in participants	2 events in participants	—

SECONDARY outcome

Timeframe: Week 32 (EOET1)/UV/ET

Population: Epoch 1 safety analysis set included all participants who received any study treatment. Participants can have more than one causally related adverse event.

AE: any untoward medical occurrence in participant administered IP. AE can therefore be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.), outcome of death temporally associated with use of IP, whether or not considered causally related to the IP. SAE: untoward medical occurrence that at any dose meets following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization/results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is congenital anomaly/birth defect, is medically important event, (e.g., thromboembolic events, hemolytic anemia). Non-SAE:AE not meeting this criteria. AE recorded by investigator as possibly/probably related to IP is considered related AE, any AE recorded as unlikely/not related is considered unrelated AE.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=70 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=62 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 1: Number of Causally Related Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions Casually Related Non-serious Adverse Events	53 causally related events in participants	223 causally related events in participants	—
Epoch 1: Number of Causally Related Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions Casually Related Serious Adverse Events	5 causally related events in participants	1 causally related events in participants	—

SECONDARY outcome

Timeframe: During an infusion or within 72 hours after completion of an infusion (up to Week 32)

Population: Epoch 1 safety analysis set included all participants who received any study treatment. Participants can have more than one temporally associated with infusion adverse event.

AEs occurring during an infusion or within 72 hours after completion of an infusion. An AE is defined as any untoward medical occurrence in participant administered an Investigational Product (IP) that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Participants can have more than one temporally associated with infusion adverse event.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=70 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=62 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 1: Number of Adverse Events (AEs) Temporally Associated With Infusions	61 events in participants	251 events in participants	—

SECONDARY outcome

Timeframe: Week 32 (EOET1)/UV/ET

Population: Epoch 1 safety analysis set included all participants who received any study treatment. Participants can have more than one AR/suspected AR associated with infusion.

AR plus suspected AR: any AE that meets any of the criteria: AE considered by either investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following end of IP infusion, or AE for which causality assessment is missing or indeterminate. SAE: untoward medical occurrence that at any dose meets one or more of following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. Nonserious AE is AE that does not meet the criteria. Infusion per event = number of events / total number of infusions administered (started) to participants in analysis set. Participants can have more than one AR/suspected AR associated with infusion.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=70 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=62 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 1: Number of Serious and/or Non-serious Adverse Reactions (ARs) Plus Suspected ARs Associated With Infusions Non-Serious AR/Suspected AR	76 events in participants	261 events in participants	—
Epoch 1: Number of Serious and/or Non-serious Adverse Reactions (ARs) Plus Suspected ARs Associated With Infusions Serious AR/Suspected AR	5 events in participants	1 events in participants	—

SECONDARY outcome

Timeframe: Week 32 (EOET1)/UV/ET

Population: Epoch 1 safety analysis set included all participants who received any study treatment. Participants can have more than one TEAE associated with infusion.

A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments. Participants can have more than one TEAE associated with infusion.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=70 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=62 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 1: Number of Treatment-emergent Systemic Adverse Events (AEs) Associated With Infusions	149 events in participants	342 events in participants	—

SECONDARY outcome

Timeframe: Week 32 (EOET1)/UV/ET

Population: Epoch 1 safety analysis set included all participants who received any study treatment.

AE=any untoward medical occurrence in participant administered an IP that does not have causal relationship with treatment. AE can be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Adverse reaction/suspected adverse reaction=AE that is considered by the investigator to be possibly or probably related to IP administration, or for which the causality is indeterminate or missing, or that begins during infusion of IP or within 72 hours following the end of IP infusion. Treatment-emergent adverse events (TEAEs) are defined as adverse events that occurred during or after administration of the first dose of IP. Infusion site adverse events and injection site adverse events refer to the same type of adverse events.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=70 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=62 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 1: Number of Treatment-emergent Local Infusion Site Reactions Associated With Infusions	20 events in participants	141 events in participants	—

SECONDARY outcome

Timeframe: Week 32 (EOET1)/UV/ET

Population: Epoch 1 safety analysis set included all participants who received any study treatment.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=647 number of infusions Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=600 number of infusions Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 1: Number of Infusions in Participants for Which the Infusion Rate Was Reduced And/Or the Infusion Was Interrupted or Stopped Due to Intolerability And/Or Adverse Events (AEs)	1 number of infusions	3 number of infusions	—

SECONDARY outcome

Timeframe: Week 32 (EOET1)/UV/ET

Population: Epoch 1 safety analysis set included all participants who received any study treatment.

An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=646 Infusions Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=600 Infusions Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 1: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Infusion Systemic Adverse Events	0.20 number of AEs/infusion	0.34 number of AEs/infusion	—
Epoch 1: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Infusion Local Adverse Events	0.03 number of AEs/infusion	0.24 number of AEs/infusion	—

SECONDARY outcome

Timeframe: Week 32 (EOET1)/UV/ET

Population: Epoch 1 safety analysis set included all participants who received any study treatment.

An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=70 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=62 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 1: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Participant Systemic AEs	1.84 number of AEs/participant	3.24 number of AEs/participant	—
Epoch 1: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Participant Local AEs	0.29 number of AEs/participant	2.27 number of AEs/participant	—

SECONDARY outcome

Timeframe: Week 32 (EOET1)/UV/ET

Population: Epoch 1 safety analysis set included all participants who received any study treatment.

An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Data for number of events per 1000 participant-years is assessed as follows: Per 1000 participant-years = 1000 x (number of events / total number of days of exposure, i.e., the sum of duration of treatment for all participants in the safety analysis set, divided by 365.25)

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=70 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=62 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 1: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per 1000 Participant-year Systemic AEs	4689.22 number of AEs/1000 participant-year	7341.52 number of AEs/1000 participant-year	—
Epoch 1: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per 1000 Participant-year Local AEs	727.01 number of AEs/1000 participant-year	5150.02 number of AEs/1000 participant-year	—

SECONDARY outcome

Timeframe: Week 32 (EOET1)/UV/ET

Population: Epoch 1 safety analysis set included all participants who received any study treatment.

An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=646 Infusions Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=600 Infusions Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 1: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed As Number of Events Per Infusion IP-Related Local TEAE	0.02 number of AEs/infusion	0.21 number of AEs/infusion	—
Epoch 1: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed As Number of Events Per Infusion IP-Related Systemic TEAE	0.06 number of AEs/infusion	0.17 number of AEs/infusion	—

SECONDARY outcome

Timeframe: Week 32 (EOET1)/UV/ET

Population: Epoch 1 safety analysis set included all participants who received any study treatment.

An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=70 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=62 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 1: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed As Number of Events Per Participant IP-related Systemic TEAE	0.54 number of AEs/participant	1.6 number of AEs/participant	—
Epoch 1: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed As Number of Events Per Participant IP-related Local TEAE	0.21 number of AEs/participant	2 number of AEs/participant	—

SECONDARY outcome

Timeframe: Week 32 (EOET1)/UV/ET

Population: Epoch 1 safety analysis set included all participants who received any study treatment.

An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=70 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=62 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 1: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed as Number of Events Per Participant-year IP-related Systemic TEAE	1381.32 number of AEs/1000 participant-year	3615.98 number of AEs/1000 participant-year	—
Epoch 1: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed as Number of Events Per Participant-year IP-related Local TEAE	545.26 number of AEs/1000 participant-year	4529.1 number of AEs/1000 participant-year	—

SECONDARY outcome

Timeframe: Week 32 (EOET1)/UV/ET

Population: Epoch 1 safety analysis set included all participants who received any study treatment.

An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=646 Infusions Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=600 Infusions Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 1: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected ARs, Expressed as Number of Events Per Infusion Systemic Plus Suspected ARs	0.09 number of ARs/infusion	0.20 number of ARs/infusion	—
Epoch 1: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected ARs, Expressed as Number of Events Per Infusion Local Plus Suspected ARs	0.03 number of ARs/infusion	0.24 number of ARs/infusion	—

SECONDARY outcome

Timeframe: Week 32 (EOET1)/UV/ET

Population: Epoch 1 safety analysis set included all participants who received any study treatment.

An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=70 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=62 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 1: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected ARs, Expressed as Number of Events Per Participant Systemic Plus Suspected ARs	0.80 number of ARs/participant	1.94 number of ARs/participant	—
Epoch 1: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected ARs, Expressed as Number of Events Per Participant Local Plus Suspected ARs	0.29 number of ARs/participant	2.27 number of ARs/participant	—

SECONDARY outcome

Timeframe: Week 32 (EOET1)/UV/ET

Population: Epoch 1 safety analysis set included all participants who received any study treatment.

An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data for number of events per 1000 participant-years is assessed as follows: Per 1000 participant-years = 1000 x (number of events / total number of days of exposure, i.e., the sum of duration of treatment for all participants in the safety analysis set, divided by 365.25)

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=70 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=62 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 1: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected ARs, Expressed as Number of Events Per 1000 Participant-Year Local Plus Suspected ARs	727.01 number of ARs/1000 Participant year	5150.02 number of ARs/1000 Participant year	—
Epoch 1: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected ARs, Expressed as Number of Events Per 1000 Participant-Year Systemic Plus Suspected ARs	2035.63 number of ARs/1000 Participant year	4383.00 number of ARs/1000 Participant year	—

SECONDARY outcome

Timeframe: Week 32 (EOET1)/UV/ET

Population: Epoch 1 safety analysis set included all participants who received any study treatment.

Number of participants who developed binding and/or neutralizing antibodies to rHuPH20 in Epoch 1 were reported. High-binding antibodies is defined as number of participants who had at least one anti-rHuPH20 antibody titer ≥1:160 during treatment.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=70 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=62 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 1: Number of Participants Who Develop Binding and/or Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20)	7 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Throughout Epoch 2, up to 6 months post-Epoch 1

Population: Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.

Number of participants experiencing any treatment-emergent serious and/or non-serious adverse events regardless of causality in Epoch 2 was reported.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=16 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=4 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C n=1 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 2: Number of Participants Experiencing Any Treatment-emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs), Regardless of Causality Any IP related TEAE	11 Participants	3 Participants	1 Participants
Epoch 2: Number of Participants Experiencing Any Treatment-emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs), Regardless of Causality Any IP related serious TEAE	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Throughout Epoch 2, up to 6 months post-Epoch 1

Population: Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.

AE: any untoward medical occurrence in participant administered IP. AE can therefore be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.), outcome of death temporally associated with use of IP, whether or not considered causally related to the IP. SAE: untoward medical occurrence that at any dose meets following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization/results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is congenital anomaly/birth defect, is medically important event, (e.g., thromboembolic events, hemolytic anemia). Non-SAE:AE not meeting this criteria. AE recorded by investigator as possibly/probably related to IP is considered related AE, any AE recorded as unlikely/not related is considered unrelated AE.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=16 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=4 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C n=1 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 2: Number of Participants Experiencing Causally Related Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Causally related AEs	8 Participants	3 Participants	0 Participants
Epoch 2: Number of Participants Experiencing Causally Related Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Causally related SAEs	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Throughout Epoch 2, up to 6 months post-Epoch 1

Population: Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.

An adverse reaction/suspected adverse reaction is defined as an Adverse Event that is considered by the investigator to be possibly or probably related to IP administration, or for which the causality is indeterminate or missing, or that begins during infusion of IP or within 72 hours following the end of IP infusion.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=16 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=4 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C n=1 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 2: Number of Participants With Serious and/or Non-serious Adverse Reactions (ARs) Plus Suspected ARs Any AR/SAR	10 Participants	3 Participants	0 Participants
Epoch 2: Number of Participants With Serious and/or Non-serious Adverse Reactions (ARs) Plus Suspected ARs Any Serious AR/SAR	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Throughout Epoch 2, up to 6 months post-Epoch 1

Population: Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C. Participants can have more than one adverse event.

A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria. An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Participants can have more than one adverse event.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=16 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=4 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C n=1 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 2: Number of Treatment-emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions Regardless of Causality Serious AEs	0 events in participants	0 events in participants	0 events in participants
Epoch 2: Number of Treatment-emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions Regardless of Causality Non-serious AEs	35 events in participants	25 events in participants	1 events in participants

SECONDARY outcome

Timeframe: Throughout Epoch 2, up to 6 months post-Epoch 1

Population: Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C. Participants can have more than one adverse event.

AE: any untoward medical occurrence in participant administered IP. AE can therefore be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.), outcome of death temporally associated with use of IP, whether or not considered causally related to the IP. SAE: untoward medical occurrence that at any dose meets following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization/results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is congenital anomaly/birth defect, is medically important event, (e.g., thromboembolic events, hemolytic anemia). Non-SAE:AE not meeting this criteria. AE recorded by investigator as possibly/probably related to IP is considered related AE, any AE recorded as unlikely/not related is considered unrelated AE.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=16 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=4 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C n=1 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 2: Number of Causally Related Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions Any TEAE	23 events in participants	0 events in participants	0 events in participants
Epoch 2: Number of Causally Related Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions Any serious TEAE	0 events in participants	0 events in participants	0 events in participants

SECONDARY outcome

Timeframe: During an infusion or within 72 hours after completion of an infusion (up to Week 32)

Population: Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C. Participants can have more than one adverse event.

AEs occurring during an infusion or within 72 hours after completion of an infusion. An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Participants can have more than one adverse event.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=16 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=4 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C n=1 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 2: Number of Adverse Events (AEs) Temporally Associated With Infusions	25 events in participants	11 events in participants	0 events in participants

SECONDARY outcome

Timeframe: Throughout Epoch 2, up to 6 months post-Epoch 1

Population: Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C. Participants can have more than one AR/SAR.

A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria. An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Participants can have more than one AR/SAR.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=16 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=4 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C n=1 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 2: Number of Serious and/or Non-serious Adverse Reactions (ARs) Plus Suspected ARs Associated With Infusions AR/SAR	28 events in participants	11 events in participants	0 events in participants
Epoch 2: Number of Serious and/or Non-serious Adverse Reactions (ARs) Plus Suspected ARs Associated With Infusions Serious AR/SAR	0 events in participants	0 events in participants	0 events in participants

SECONDARY outcome

Timeframe: Throughout Epoch 2, up to 6 months post-Epoch 1

Population: Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C. Participants can have more than one treatment-emergent systemic AEs.

A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments. Participants can have more than one treatment-emergent systemic AEs.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=16 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=4 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C n=1 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 2: Number of Treatment-emergent Systemic Adverse Events (AEs) Associated With Infusions	35 events in participants	25 events in participants	1 events in participants

SECONDARY outcome

Timeframe: Throughout Epoch 2, up to 6 months post-Epoch 1

Population: Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.

AE=any untoward medical occurrence in participant administered an IP that does not have causal relationship with treatment. AE can be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Adverse reaction/suspected adverse reaction=AE that is considered by the investigator to be possibly or probably related to IP administration, or for which the causality is indeterminate or missing, or that begins during infusion of IP or within 72 hours following the end of IP infusion. TEAEs are defined as adverse events that occurred during or after administration of the first dose of IP. Infusion site adverse events and injection site adverse events refer to the same type of adverse events.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=16 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=4 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C n=1 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 2: Number of Treatment-emergent Local Infusion Site Reactions Associated With Infusions	0 events in participants	0 events in participants	0 events in participants

SECONDARY outcome

Timeframe: Throughout Epoch 2, up to 6 months post-Epoch 1

Population: Epoch 2 IGIV Analysis Set included participants who relapsed in Epoch 1 and received at least one dose of IGIV treatment (GGL/KIOVIG or GAMMUNEX-C).

An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=328 number of infusions Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=61 number of infusions Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 2: Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Intolerability and/or Adverse Events (AEs)	1 number of infusions	1 number of infusions	—

SECONDARY outcome

Timeframe: Throughout Epoch 2, up to 6 months post-Epoch 1

Population: Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.

An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=328 Infusions Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=61 Infusions Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C n=18 Infusions Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 2: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Infusion Systemic AEs	0.11 number of AEs/infusion	0.41 number of AEs/infusion	0.06 number of AEs/infusion
Epoch 2: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Infusion Local AEs	0 number of AEs/infusion	0 number of AEs/infusion	0 number of AEs/infusion

SECONDARY outcome

Timeframe: Throughout Epoch 2, up to 6 months post-Epoch 1

Population: Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.

An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=16 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=4 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C n=1 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 2: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Participant Systemic AEs	2.19 number of AEs/participant	6.25 number of AEs/participant	1.00 number of AEs/participant
Epoch 2: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Participant Local AEs	0 number of AEs/participant	0 number of AEs/participant	0 number of AEs/participant

SECONDARY outcome

Timeframe: Throughout Epoch 2, up to 6 months post-Epoch 1

Population: Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.

An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=16 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=4 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C n=1 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 2: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per 1000 Participant-year Systemic AEs	4645.26 number of AEs/1000 participant-year	12806.80 number of AEs/1000 participant-year	2135.96 number of AEs/1000 participant-year
Epoch 2: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per 1000 Participant-year Local AEs	0 number of AEs/1000 participant-year	0 number of AEs/1000 participant-year	0 number of AEs/1000 participant-year

SECONDARY outcome

Timeframe: Throughout Epoch 2, up to 6 months post-Epoch 1

Population: Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.

An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=328 Infusions Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=61 Infusions Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C n=18 Infusions Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 2: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed As Number of Events Per Infusion IP-related Systemic Adverse Events	0.07 number of AEs/infusion	0.13 number of AEs/infusion	0 number of AEs/infusion
Epoch 2: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed As Number of Events Per Infusion IP-related Local Adverse Events	0 number of AEs/infusion	0 number of AEs/infusion	0 number of AEs/infusion

SECONDARY outcome

Timeframe: Throughout Epoch 2, up to 6 months post-Epoch 1

Population: Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.

An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=16 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=4 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C n=1 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 2: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed as Number of Events Per Participant IP-related Systemic Adverse Events	1.44 number of AEs/participant	2 number of AEs/participant	0 number of AEs/participant
Epoch 2: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed as Number of Events Per Participant IP-related Local Adverse Events	0 number of AEs/participant	0 number of AEs/participant	0 number of AEs/participant

SECONDARY outcome

Timeframe: Throughout Epoch 2, up to 6 months post-Epoch 1

Population: Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.

An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=16 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=4 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C n=1 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 2: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed as Number of Events Per Participant-Year IP-related Systemic Adverse Events	3052.6 number of AEs/1000 participant-year	4098.18 number of AEs/1000 participant-year	0 number of AEs/1000 participant-year
Epoch 2: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed as Number of Events Per Participant-Year IP-related Local Adverse Events	0 number of AEs/1000 participant-year	0 number of AEs/1000 participant-year	0 number of AEs/1000 participant-year

SECONDARY outcome

Timeframe: Throughout Epoch 2, up to 6 months post-Epoch 1

Population: Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.

An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=328 Infusions Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=16 Infusions Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C n=18 Infusions Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 2: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected Ars, Expressed as Number of Events Per Infusion Systemic plus Suspected ARs	0.09 number of ARs/infusion	0.18 number of ARs/infusion	0 number of ARs/infusion
Epoch 2: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected Ars, Expressed as Number of Events Per Infusion Local plus Suspected ARs	0 number of ARs/infusion	0 number of ARs/infusion	0 number of ARs/infusion

SECONDARY outcome

Timeframe: Throughout Epoch 2, up to 6 months post-Epoch 1

Population: Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.

An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=16 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=4 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C n=1 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 2: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected ARs, Expressed as Number of Events Per Participant Systemic plus Suspected ARs	1.75 number of ARs/participant	2.75 number of ARs/participant	0 number of ARs/participant
Epoch 2: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected ARs, Expressed as Number of Events Per Participant Local plus Suspected ARs	0 number of ARs/participant	0 number of ARs/participant	0 number of ARs/participant

SECONDARY outcome

Timeframe: Throughout Epoch 2, up to 6 months post-Epoch 1

Population: Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.

An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data for number of events per 1000 participant-years is assessed as follows: Per 1000 participant-years = 1000 x (number of events / total number of days of exposure, i.e., the sum of duration of treatment for all participants in the safety analysis set, divided by 365.25)

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=16 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=4 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C n=1 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 2: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected ARs, Expressed as Number of Events Per 1000 Participant-Year Systemic plus Suspected ARs	3716.21 number of ARs/1000 participant-year	5634.99 number of ARs/1000 participant-year	0 number of ARs/1000 participant-year
Epoch 2: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected ARs, Expressed as Number of Events Per 1000 Participant-Year Local plus Suspected ARs	0 number of ARs/1000 participant-year	0 number of ARs/1000 participant-year	0 number of ARs/1000 participant-year

SECONDARY outcome

Timeframe: Throughout Epoch 2, up to 6 months post-Epoch 1

Population: Epoch 2 IGIV Analysis Set included participants who relapsed in Epoch 1 and received at least one dose of IGIV treatment (GGL/KIOVIG or GAMMUNEX-C)

Defined as one or more of the following: a decrease of \>=1 point in the adjusted Inflammatory Neuropathy Cause and Treatment disability scale (INCAT) score at 2 consecutive time points; who experience CIDP improvement (defined as ≥8 kilo Pascal (kPa) increase in hand grip strength in the more affected hand; \>=4 points increase in Rasch-built Overall Disability Scale (R-ODS)) at the completion of the intravenous (IV) treatment period \[6 months\] or at the last study visit of the IV treatment period, relative to the pre-IV treatment baseline score.

Outcome measures

Outcome measures
Measure	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=17 Participants Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=4 Participants Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Epoch 2: Percentage of Participants With Clinically Meaningful Improvement in Functional Ability	100 percentage of participants Interval 80.64 to 100.0	100 percentage of participants	—

Adverse Events

Epoch 1: Placebo With rHuPH20

Serious events: 5 serious events

Other events: 19 other events

Deaths: 0 deaths

Epoch 1: HYQVIA/HyQvia

Serious events: 2 serious events

Other events: 42 other events

Deaths: 0 deaths

Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Epoch 1: Placebo With rHuPH20 n=70 participants at risk Participants received rHuPH20 80 U/10 mL solution, followed by SC placebo infusion at matching infusion volume as per the participant's pre-randomization monthly equivalent IG dose when administered every 2, 3, or 4 weeks for 31.54 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=62 participants at risk Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=16 participants at risk Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG n=4 participants at risk Participants who were enrolled to receive HYQVIA/HyQvia (rHuPH20) and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 28.67 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C n=1 participants at risk Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Cardiac disorders Arrhythmia	1.4% 1/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
Nervous system disorders Cerebrovascular accident	0.00% 0/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	1.6% 1/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
Nervous system disorders Chronic inflammatory demyelinating polyradiculoneuropathy	5.7% 4/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
Infections and infestations Otitis media chronic	0.00% 0/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	1.6% 1/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.

Other adverse events

Other adverse events
Measure	Epoch 1: Placebo With rHuPH20 n=70 participants at risk Participants received rHuPH20 80 U/10 mL solution, followed by SC placebo infusion at matching infusion volume as per the participant's pre-randomization monthly equivalent IG dose when administered every 2, 3, or 4 weeks for 31.54 weeks or until relapse.	Epoch 1: HYQVIA/HyQvia n=62 participants at risk Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG n=16 participants at risk Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.	Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG n=4 participants at risk Participants who were enrolled to receive HYQVIA/HyQvia (rHuPH20) and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 28.67 weeks or until relapse.	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C n=1 participants at risk Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as per the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	25.0% 1/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
Blood and lymphatic system disorders Anaemia	1.4% 1/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	6.2% 1/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
Musculoskeletal and connective tissue disorders Back pain	2.9% 2/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	6.5% 4/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
Reproductive system and breast disorders Benign prostatic hyperplasia	1.4% 1/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	100.0% 1/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
Investigations Blood creatinine increased	0.00% 0/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	6.2% 1/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
General disorders Chest pain	0.00% 0/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	6.2% 1/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
General disorders Chills	0.00% 0/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	1.6% 1/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	25.0% 1/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
Gastrointestinal disorders Diarrhoea	7.1% 5/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
Nervous system disorders Dizziness	1.4% 1/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	6.5% 4/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	6.2% 1/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
Ear and labyrinth disorders Ear pain	0.00% 0/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	25.0% 1/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
General disorders Fatigue	2.9% 2/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	9.7% 6/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	6.2% 1/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
Nervous system disorders Headache	11.4% 8/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	12.9% 8/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	37.5% 6/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	50.0% 2/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
Vascular disorders Hypertension	1.4% 1/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	6.5% 4/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
General disorders Illness	0.00% 0/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	6.2% 1/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
General disorders Infusion site erythema	0.00% 0/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	9.7% 6/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
General disorders Infusion site oedema	1.4% 1/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	6.5% 4/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
General disorders Infusion site pain	2.9% 2/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	8.1% 5/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
General disorders Infusion site pruritus	0.00% 0/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	6.5% 4/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
General disorders Injection site erythema	0.00% 0/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	11.3% 7/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
General disorders Injection site pain	2.9% 2/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	8.1% 5/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
General disorders Injection site pruritus	0.00% 0/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	6.5% 4/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
Blood and lymphatic system disorders Leukopenia	0.00% 0/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	1.6% 1/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	6.2% 1/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
Nervous system disorders Migraine	0.00% 0/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	6.2% 1/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	6.2% 1/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
Infections and infestations Nasopharyngitis	1.4% 1/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	1.6% 1/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	25.0% 1/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
Gastrointestinal disorders Nausea	2.9% 2/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	11.3% 7/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
Blood and lymphatic system disorders Neutropenia	0.00% 0/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	1.6% 1/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	6.2% 1/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
General disorders Pain	0.00% 0/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	25.0% 1/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
Musculoskeletal and connective tissue disorders Pain in extremity	1.4% 1/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	4.8% 3/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	25.0% 1/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
Skin and subcutaneous tissue disorders Pruritus	1.4% 1/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	8.1% 5/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
General disorders Pyrexia	1.4% 1/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	11.3% 7/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	6.2% 1/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	25.0% 1/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
Nervous system disorders Somnolence	0.00% 0/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	1.6% 1/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	6.2% 1/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
Nervous system disorders Tremor	0.00% 0/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	3.2% 2/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	6.2% 1/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.
Gastrointestinal disorders Vomiting	5.7% 4/70 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	1.6% 1/62 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/16 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	25.0% 1/4 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.	0.00% 0/1 • From the date of signing of the informed consent form up to the end of the study, approximately 74 months. Epoch 1 safety analysis set included all participants who received any study treatment. Epoch 2 safety analysis set included all participants who had a relapse in Epoch 1, entered Epoch 2, and received IGIV treatment with either GGL/KIOVIG or GAMUNEX-C.

Additional Information

Study Director

Shire

Phone: +18668425335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Publication restrictions are in place

Restriction type: OTHER