Trial Outcomes & Findings for An Extension Study of TAK-664 for Japanese People With Primary Immunodeficiency Disease (NCT NCT04842643)

NCT ID: NCT04842643

Last Updated: 2025-01-20

Results Overview

TEAEs were defined as adverse events (AEs) with onset after date-time of first dose of study drug (intravenous immunoglobulin \[IGIV\] or IGSC), or medical conditions present prior to the start of study drug (IGIV or IGSC) but increased in severity or relationship after date-time of first dose of study drug (IGIV or IGSC). A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 12 participants
• Primary outcome timeframe: From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose
• Results posted on: 2025-01-20

Participant Flow

Participants took part in the study at 8 investigative sites in Japan from 27 April 2021 to 25 April 2024.

Participants with primary immunodeficiency disorders who completed core study TAK-664-3001 (NCT04346108) were enrolled to receive Immune globulin subcutaneous (IGCS), 20 percent (%) in this current extension study (TAK-664-3002 [NCT04842643]). As per planned analysis, the data was collected, analyzed and reported for a single arm only and per dose level wise data was not collected in this study.

Participant milestones

Measure	IGSC, 20% Participants who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.
Overall Study STARTED	12
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	IGSC, 20% Participants who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.
Overall Study Physician Decision	1
Overall Study Other	1

Baseline Characteristics

An Extension Study of TAK-664 for Japanese People With Primary Immunodeficiency Disease

Baseline characteristics by cohort

Measure	IGSC, 20% n=12 Participants Participants who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.
Age, Continuous	36.0 years STANDARD_DEVIATION 21.68 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose

Population: All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.

TEAEs were defined as adverse events (AEs) with onset after date-time of first dose of study drug (intravenous immunoglobulin [IGIV] or IGSC), or medical conditions present prior to the start of study drug (IGIV or IGSC) but increased in severity or relationship after date-time of first dose of study drug (IGIV or IGSC). A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important.

Outcome measures

Measure	IGSC, 20% n=12 Participants Participants who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.	IGSC, 20%: >=14 Years Participants aged greater than or equal to (\>=) 14 years and who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs TEAEs	12 Participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs Serious TEAEs	3 Participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs Non-serious TEAEs	12 Participants	—

PRIMARY outcome

Timeframe: From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose

Population: All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.

TEAEs were defined as adverse events (AEs) with onset after date-time of first dose of study drug (intravenous immunoglobulin [IGIV] or IGSC), or medical conditions present prior to the start of study drug (IGIV or IGSC) but increased in severity or relationship after date-time of first dose of study drug (IGIV or IGSC). Any TEAE that was recorded by the investigator as "probably related" or "possibly related" to study drug was considered as study drug related AE, and any AE recorded as "unlikely related" or "not related" was considered as unrelated AE.

Outcome measures

Measure	IGSC, 20% n=12 Participants Participants who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.	IGSC, 20%: >=14 Years Participants aged greater than or equal to (\>=) 14 years and who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.
Number of Participants With Drug-related and Non-related TEAEs Drug-related TEAEs	9 Participants	—
Number of Participants With Drug-related and Non-related TEAEs Non-related TEAEs	12 Participants	—

PRIMARY outcome

Timeframe: From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose

Population: All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.

A severe TEAE was an AE that caused considerable interference with the participant's usual activities. Local TEAEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infusion site". Systemic TEAEs were defined as AEs that were not included in the Medical Dictionary for Regulatory Activities (MedDRA) Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site" or "infusion site".

Outcome measures

Measure	IGSC, 20% n=12 Participants Participants who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.	IGSC, 20%: >=14 Years Participants aged greater than or equal to (\>=) 14 years and who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.
Number of Participants With Severe, Local and Systemic TEAEs Severe TEAEs	3 Participants	—
Number of Participants With Severe, Local and Systemic TEAEs Local TEAEs	8 Participants	—
Number of Participants With Severe, Local and Systemic TEAEs Systemic TEAEs	12 Participants	—

PRIMARY outcome

Timeframe: From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose

Population: All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.

Infusion associated TEAEs were defined as any TEAE that began during study drug infusion or within 72 hours of completion of study drug infusion. TEAEs leading to premature discontinuation from study and infusion-associated TEAEs were reported.

Outcome measures

Measure	IGSC, 20% n=12 Participants Participants who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.	IGSC, 20%: >=14 Years Participants aged greater than or equal to (\>=) 14 years and who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.
Number of Participants With TEAEs Leading to Premature Discontinuation From Study and Infusion-associated TEAEs TEAEs Leading to Premature Discontinuation	0 Participants	—
Number of Participants With TEAEs Leading to Premature Discontinuation From Study and Infusion-associated TEAEs Infusion-associated TEAEs	12 Participants	—

SECONDARY outcome

Timeframe: At end of treatment in the current extension study TAK-664-3002 (i.e. 3 years)

Population: All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study. Here" overall number of participants analyzed" signified participants who were evaluable for this outcome measure.

Serum trough levels of total IgG and IgG1, IgG2, IgG3, IgG4 antibodies subclasses were determined by using standard assay methods.

Outcome measures

Measure	IGSC, 20% n=5 Participants Participants who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.	IGSC, 20%: >=14 Years Participants aged greater than or equal to (\>=) 14 years and who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.
Serum Trough Levels of Total Immune Globulin G (IgG) and IgG1, IgG2, IgG3, IgG4 Antibodies Subclasses Following Weekly Administration of IGSC, 20% IgG 4	0.305 grams per liter (g/L) Interval 0.165 to 0.567	—
Serum Trough Levels of Total Immune Globulin G (IgG) and IgG1, IgG2, IgG3, IgG4 Antibodies Subclasses Following Weekly Administration of IGSC, 20% IgG 1	6.14 grams per liter (g/L) Interval 4.25 to 8.87	—
Serum Trough Levels of Total Immune Globulin G (IgG) and IgG1, IgG2, IgG3, IgG4 Antibodies Subclasses Following Weekly Administration of IGSC, 20% IgG 2	3.52 grams per liter (g/L) Interval 2.35 to 5.28	—
Serum Trough Levels of Total Immune Globulin G (IgG) and IgG1, IgG2, IgG3, IgG4 Antibodies Subclasses Following Weekly Administration of IGSC, 20% IgG 3	NA grams per liter (g/L) Geometric mean and 95% confidence interval (CI) could not be calculated because the values were below lower limit of quantification (LLOQ).	—
Serum Trough Levels of Total Immune Globulin G (IgG) and IgG1, IgG2, IgG3, IgG4 Antibodies Subclasses Following Weekly Administration of IGSC, 20% IgG Total	11.0 grams per liter (g/L) Interval 7.29 to 16.5	—

SECONDARY outcome

Timeframe: At end of treatment in the current extension study TAK-664-3002 (i.e. 3 years)

Population: All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study. Here" overall number of participants analyzed" signified participants who were evaluable for this outcome measure.

Serum trough levels of IgG and IgG1, IgG2, IgG3, IgG4 antibodies subclasses were determined by using standard assay methods.

Outcome measures

Measure	IGSC, 20% n=7 Participants Participants who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.	IGSC, 20%: >=14 Years Participants aged greater than or equal to (\>=) 14 years and who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.
Serum Trough Levels of IgG and IgG1, IgG2, IgG3, IgG4 Antibodies Subclasses Following Biweekly Administration of IGSC, 20% IgG 1	5.36 g/L Interval 4.55 to 6.33	—
Serum Trough Levels of IgG and IgG1, IgG2, IgG3, IgG4 Antibodies Subclasses Following Biweekly Administration of IGSC, 20% IgG 2	3.42 g/L Interval 3.03 to 3.86	—
Serum Trough Levels of IgG and IgG1, IgG2, IgG3, IgG4 Antibodies Subclasses Following Biweekly Administration of IGSC, 20% IgG 3	NA g/L Geometric mean and 95% CI could not be calculated because the values were below LLOQ.	—
Serum Trough Levels of IgG and IgG1, IgG2, IgG3, IgG4 Antibodies Subclasses Following Biweekly Administration of IGSC, 20% IgG 4	0.250 g/L Interval 0.219 to 0.284	—
Serum Trough Levels of IgG and IgG1, IgG2, IgG3, IgG4 Antibodies Subclasses Following Biweekly Administration of IGSC, 20% IgG Total	8.98 g/L Interval 7.78 to 10.4	—

SECONDARY outcome

Timeframe: From first dose of study drug in core study TAK-664-3001 up to end of current extension study TAK-664-3002 (up to approximately 4.5 years)

Population: The Core Study All-Treated Set consisted of participants who received at least 1 dose of study drug (IGIV or IGSC) in TAK-664-3001.

The ASBI rate was calculated as the mean number of acute serious bacterial infections per participants per year. Annual rate of validated acute serious bacterial infections per participant was assessed. Reported timeframe included timeframe of core study TAK-664-3001 (NCT04346108) (Max approximately 1.5 year) and of current extension study (Max approximately 3 years) as data of this outcome measure was collected from first dose of core study to end of current extension study and the data is presented for participants who entered in current study from core study as per plan.

Outcome measures

Measure	IGSC, 20% n=12 Participants Participants who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.	IGSC, 20%: >=14 Years Participants aged greater than or equal to (\>=) 14 years and who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.
Annual Rate of Validated Acute Serious Bacterial Infections (ASBI)	0.00 infections per year Standard Deviation 0.000	—

SECONDARY outcome

Timeframe: From first dose of study drug in core study TAK-664-3001 up to end of current extension study TAK-664-3002 (up to approximately 4.5 years)

Population: The Core Study All-Treated Set consisted of participants who received at least 1 dose of study drug (IGIV or IGSC) in TAK-664-3001.

The annual rate of infections was calculated as the mean number of infections per participant per year. Reported timeframe included timeframe of core study TAK-664-3001 (NCT04346108) (Max approximately 1.5 year) and of current extension study (Max approximately 3 years) as data of this outcome measure was collected from first dose of core study to end of current extension study and the data is presented for participants who entered in current study from core study as per plan.

Outcome measures

Measure	IGSC, 20% n=12 Participants Participants who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.	IGSC, 20%: >=14 Years Participants aged greater than or equal to (\>=) 14 years and who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.
Annual Rate of All Infections	1.42 infections per year Standard Deviation 1.119	—

SECONDARY outcome

Timeframe: From first dose of study drug in core study TAK-664-3001 up to end of current extension study TAK-664-3002 (up to approximately 4.5 years)

Population: The Core Study All-Treated Set consisted of participants who received at least 1 dose of study drug (IGIV or IGSC) in TAK-664-3001.

Number of days not able to attend school or work to perform normal daily activities due to illness/infection are standardized per year (365.25 days). Reported timeframe included timeframe of core study TAK-664-3001 (NCT04346108) (Max approximately 1.5 year) and of current extension study (Max approximately 3 years) as data of this outcome measure was collected from first dose of core study to end of current extension study and the data is presented for participants who entered in current study from core study as per plan.

Outcome measures

Measure	IGSC, 20% n=12 Participants Participants who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.	IGSC, 20%: >=14 Years Participants aged greater than or equal to (\>=) 14 years and who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.
Number of Days Participants Not Able to Attend School or Work to Perform Normal Daily Activities Due to Illness/Infection	1.91 days Interval 0.0 to 31.9	—

SECONDARY outcome

Timeframe: From first dose of study drug in core study TAK-664-3001 up to end of current extension study TAK-664-3002 (up to approximately 4.5 years)

Population: The Core Study All-Treated Set consisted of participants who received at least 1 dose of study drug (IGIV or IGSC) in TAK-664-3001.

Number of days on antibiotics was defined as the number of days those antibiotics were taken as concomitant medications and was standardized to per year (365.25 days). Number of days participants on antibiotics were reported. Reported timeframe included timeframe of core study TAK-664-3001 (NCT04346108) (Max approximately 1.5 year) and of current extension study (Max approximately 3 years) as data of this outcome measure was collected from first dose of core study to end of current extension study and the data is presented for participants who entered in current study from core study as per plan.

Outcome measures

Measure	IGSC, 20% n=12 Participants Participants who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.	IGSC, 20%: >=14 Years Participants aged greater than or equal to (\>=) 14 years and who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.
Number of Days Participants on Antibiotics	2.55 days Interval 0.0 to 57.8	—

SECONDARY outcome

Timeframe: From first dose of study drug in core study TAK-664-3001 up to end of current extension study TAK-664-3002 (up to approximately 4.5 years)

Population: The Core Study All-Treated Set consisted of participants who received at least 1 dose of study drug (IGIV or IGSC) in TAK-664-3001.

Number of hospitalizations were standardized to per year (365.25 days). Hospitalizations were measured by asking participants to report the number of nights they have stayed overnight in the hospital during the year, for something related to their own health. Number of hospitalizations due to illness or infection were reported. Reported timeframe included timeframe of core study TAK-664-3001 (NCT04346108) (Max approximately 1.5 year) and of current extension study (Max approximately 3 years) as data of this outcome measure was collected from first dose of core study to end of current extension study and the data is presented for participants who entered in current study from core study as per plan.

Outcome measures

Measure	IGSC, 20% n=12 Participants Participants who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.	IGSC, 20%: >=14 Years Participants aged greater than or equal to (\>=) 14 years and who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.
Number of Hospitalizations Due to Illness or Infection	0.21 hospitalization Standard Deviation 0.370	—

SECONDARY outcome

Timeframe: From first dose of study drug in core study TAK-664-3001 up to end of current extension study TAK-664-3002 (up to approximately 4.5 years)

Population: The Core Study All-Treated Set consisted of participants who received at least 1 dose of study drug (IGIV or IGSC) in TAK-664-3001. Here" overall number of participants analyzed" signified participants who were evaluable for this outcome measure.

Length of hospital stay per stay was standardized to per year (365.25 days). Number of days due to illness or infection were reported. Reported timeframe included timeframe of core study TAK-664-3001 (NCT04346108) (Max approximately 1.5 year) and of current extension study (Max approximately 3 years) as data of this outcome measure was collected from first dose of core study to end of current extension study and the data is presented for participants who entered in current study from core study as per plan.

Outcome measures

Measure	IGSC, 20% n=11 Participants Participants who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.	IGSC, 20%: >=14 Years Participants aged greater than or equal to (\>=) 14 years and who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.
Length of Hospital Stay Due to Illness or Infection	0.00 days Interval 0.0 to 3.9	—

SECONDARY outcome

Timeframe: From first dose of study drug in core study TAK-664-3001 up to end of current extension study TAK-664-3002 (up to approximately 4.5 years)

Population: The Core Study All-Treated Set consisted of participants who received at least 1 dose of study drug (IGIV or IGSC) in TAK-664-3001.

Number of acute physician visits is standardized to per year (365.25 days). Number of acute (urgent or unscheduled) physician visits due to illness/infection were reported. Reported timeframe included timeframe of core study TAK-664-3001 (NCT04346108) (Max approximately 1.5 year) and of current extension study (Max approximately 3 years) as data of this outcome measure was collected from first dose of core study to end of current extension study and the data is presented for participants who entered in current study from core study as per plan.

Outcome measures

Measure	IGSC, 20% n=12 Participants Participants who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.	IGSC, 20%: >=14 Years Participants aged greater than or equal to (\>=) 14 years and who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.
Number of Acute Physician Visits Due to Illness/Infection	2.66 visits per year Standard Deviation 2.652	—

SECONDARY outcome

Timeframe: From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose

Population: All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study. As pre-specified in protocol, data was planned to be reported as per age criteria (2-13 years and \>=14 years) for this outcome measure.

Treatment preference questionnaire is a self-administered questionnaire developed to assess participant's preference towards the administration of new IGSC therapy. There are 4-items on the questionnaire, which investigate a participant's preference on the clinic/hospital/home setting of receiving the immunoglobulin therapy, the participant's rating on the frequency and method of administration, and the participant's preference to continue receiving the IGSC treatment. For First question "Before participation in the trial(s), where did you receive your immunoglobulin therapy" participants were allowed to select multiple answers for options ("At the hospital"; "At home"; "Other") for their treatment. As a result, the sum of responders in the arm "IGSC, 20%: >=14 Years" for the first question were higher than the total number of participants analyzed in the category.

Outcome measures

Measure	IGSC, 20% n=3 Participants Participants who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.	IGSC, 20%: >=14 Years n=9 Participants Participants aged greater than or equal to (\>=) 14 years and who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.
Number of Participants With Their Response for Treatment Preference Questionnaire Before participation in the trial(s), where did you receive your immunoglobulin therapy: At home	0 Participants	0 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Before participation in trial(s), where did you receive your immunoglobulin therapy: At hospital	3 Participants	8 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Before participation in the trial(s), where did you receive your immunoglobulin therapy: Other	0 Participants	4 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Where do you Prefer to Receive Your Immunoglobulin Therapy: At Hospital	1 Participants	1 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Where do you Prefer to Receive Your Immunoglobulin Therapy: At Home	0 Participants	6 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Where do you Prefer to Receive Your Immunoglobulin Therapy: No Preference	2 Participants	2 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The Frequency of Administration: Like very much	1 Participants	1 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The Frequency of Administration: Like	1 Participants	4 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The Frequency of Administration: No preference	1 Participants	3 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The Frequency of Administration: Dislike	0 Participants	1 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The Frequency of Administration: Dislike very much	0 Participants	0 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The number of needlesticks per month: Like very much	1 Participants	1 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The number of needlesticks per month: Like	1 Participants	5 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The number of needlesticks per month: No preference	1 Participants	2 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The number of needlesticks per month: Dislike	0 Participants	1 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The number of needlesticks per month: Dislike very much	0 Participants	0 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Total time spent for treatment per month: Like very much	0 Participants	3 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Total time spent for treatment per month: Like	1 Participants	2 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Total time spent for treatment per month: No preference	1 Participants	1 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Total time spent for treatment per month: Dislike	1 Participants	3 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Total time spent for treatment per month: Dislike very much	0 Participants	0 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The ease of administration: Like very much	1 Participants	3 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The ease of administration: Like	2 Participants	4 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The ease of administration: No preference	0 Participants	1 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The ease of administration: Dislike	0 Participants	1 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The ease of administration: Dislike very much	0 Participants	0 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The potential to self-administer: Like very much	2 Participants	5 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The potential to self-administer: Like	0 Participants	4 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The potential to self-administer: No preference	0 Participants	0 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The potential to self-administer: Dislike	0 Participants	0 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The potential to self-administer: Dislike very much	1 Participants	0 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Ability to fit treatment into schedule: Like very much	1 Participants	5 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Ability to fit treatment into schedule: Like	2 Participants	1 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Ability to fit treatment into schedule: No preference	0 Participants	3 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Ability to fit treatment into schedule: Dislike	0 Participants	0 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Ability to fit treatment into schedule: Dislike very much	0 Participants	0 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The overall convenience: Like very much	0 Participants	4 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The overall convenience: Like	3 Participants	3 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The overall convenience: No preference	0 Participants	2 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The overall convenience: Dislike	0 Participants	0 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The overall convenience: Dislike very much	0 Participants	0 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The amount of time administration takes: Like very much	0 Participants	1 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The amount of time administration takes: Like	1 Participants	5 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The amount of time administration takes: No preference	1 Participants	1 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The amount of time administration takes: Dislike	1 Participants	2 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire The amount of time administration takes: Dislike very much	0 Participants	0 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Complexity of administration: Like very much	0 Participants	2 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Complexity of administration process: Like	3 Participants	4 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Complexity of administration: No preference	0 Participants	2 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Complexity of administration: Dislike	0 Participants	1 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Complexity of administration: Dislike very much	0 Participants	0 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Ability to self-administer: Like very much	2 Participants	6 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Ability to self-administer: Like	1 Participants	3 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Ability to self-administer: No preference	0 Participants	0 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Ability to self-administer: Dislike very much	0 Participants	0 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Ability to self-administer: Dislike	0 Participants	0 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Choose to continue receiving IGSC: Yes	3 Participants	7 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Choose to continue receiving IGSC: No	0 Participants	2 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Factor influence decision: Two way needle, to see more variation in volume of chemical solution.	0 Participants	1 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Factor influenced decision: Can be self-administered at home	1 Participants	0 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Factor influenced decision: Easy administration method, easy to use	0 Participants	1 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Factor influenced decision: Feel relieved	0 Participants	1 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Factor influenced decision: Fewer side effects. IgG levels stabilized and became easier	0 Participants	1 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Factor influence decision:.Take time to prepare, clean up, for area affected by needle to recover.	0 Participants	1 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Factor influenced decision: Less susceptible to infections. Atopic dermatitis improved	1 Participants	0 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Factor influenced decision: No answer	1 Participants	0 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Factor influenced decision: No more coughing	0 Participants	1 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Factor influenced decision: The values are stable	0 Participants	1 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Factor influenced decision: Time is short	0 Participants	1 Participants
Number of Participants With Their Response for Treatment Preference Questionnaire Factor influence decision: There were no major side effects and stable medical condition	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose

Population: The Safety Analysis Set (SAS) consisted of all participants who received at least 1 dose of study drug (IGIV or IGSC).

An infusion was considered tolerable if the infusion rate was not reduced, or the infusion was not interrupted or stopped, due to a TEAE related to study drug infusion. A tolerability event was considered to have occurred if an infusion was not tolerable.

Outcome measures

Measure	IGSC, 20% n=12 Participants Participants who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.	IGSC, 20%: >=14 Years Participants aged greater than or equal to (\>=) 14 years and who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.
Number of Participants With Tolerability Events Related to the Infusion of Study Drug Infusion rate was reduced	1 Participants	—
Number of Participants With Tolerability Events Related to the Infusion of Study Drug Infusion was interrupted	4 Participants	—
Number of Participants With Tolerability Events Related to the Infusion of Study Drug Infusion was stopped	1 Participants	—

Adverse Events

IGSC, 20%

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	IGSC, 20% n=12 participants at risk Participants who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenocarcinoma	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Metabolism and nutrition disorders Diabetic ketoacidosis	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Eye disorders Rhegmatogenous retinal detachment	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.

Other adverse events

Measure	IGSC, 20% n=12 participants at risk Participants who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available.
Gastrointestinal disorders Abdominal discomfort	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Gastrointestinal disorders Abdominal pain	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Skin and subcutaneous tissue disorders Acne	16.7% 2/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
General disorders Administration site discolouration	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Investigations Alanine aminotransferase increased	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Immune system disorders Allergy to arthropod bite	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Cardiac disorders Angina pectoris	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Gastrointestinal disorders Aphthous ulcer	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Musculoskeletal and connective tissue disorders Arthritis	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Investigations Aspartate aminotransferase increased	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Eye disorders Asthenopia	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Musculoskeletal and connective tissue disorders Back pain	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Eye disorders Blepharitis	16.7% 2/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Infections and infestations Bronchitis	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Infections and infestations COVID-19	41.7% 5/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
General disorders Chills	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Eye disorders Chorioretinopathy	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Infections and infestations Conjunctivitis	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Eye disorders Conjunctivitis allergic	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Gastrointestinal disorders Constipation	16.7% 2/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Skin and subcutaneous tissue disorders Cutaneous amyloidosis	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Infections and infestations Cystitis	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Gastrointestinal disorders Dental caries	25.0% 3/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Skin and subcutaneous tissue disorders Dermatitis atopic	16.7% 2/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Metabolism and nutrition disorders Diabetic ketoacidosis	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Gastrointestinal disorders Diarrhoea	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Nervous system disorders Dizziness	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Skin and subcutaneous tissue disorders Drug eruption	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Immune system disorders Drug hypersensitivity	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Eye disorders Dry eye	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Skin and subcutaneous tissue disorders Dry skin	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Skin and subcutaneous tissue disorders Dyshidrotic eczema	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Reproductive system and breast disorders Dysmenorrhoea	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Skin and subcutaneous tissue disorders Eczema asteatotic	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Infections and infestations Gastroenteritis	25.0% 3/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Gastrointestinal disorders Gingival pain	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Gastrointestinal disorders Haematochezia	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Gastrointestinal disorders Haemorrhoids	16.7% 2/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Gastrointestinal disorders Haemorrhoids thrombosed	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Nervous system disorders Headache	50.0% 6/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Injury, poisoning and procedural complications Heat illness	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Infections and infestations Herpes zoster	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Infections and infestations Hordeolum	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Skin and subcutaneous tissue disorders Hyperkeratosis	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Metabolism and nutrition disorders Hyperlipidaemia	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Vascular disorders Hypertension	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Nervous system disorders Hypoaesthesia	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Infections and infestations Impetigo	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Infections and infestations Influenza	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
General disorders Influenza like illness	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
General disorders Infusion site bruising	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
General disorders Infusion site erythema	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
General disorders Infusion site pain	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
General disorders Infusion site pruritus	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
General disorders Infusion site swelling	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
General disorders Injection site bruising	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
General disorders Injection site erythema	25.0% 3/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
General disorders Injection site haemorrhage	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
General disorders Injection site pain	25.0% 3/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
General disorders Injection site reaction	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
General disorders Injection site swelling	33.3% 4/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Infections and infestations Laryngitis	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Injury, poisoning and procedural complications Lip injury	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
General disorders Malaise	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Musculoskeletal and connective tissue disorders Myalgia	16.7% 2/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Infections and infestations Nasopharyngitis	25.0% 3/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Gastrointestinal disorders Nausea	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Musculoskeletal and connective tissue disorders Nodal osteoarthritis	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Investigations Occult blood positive	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Infections and infestations Oral herpes	16.7% 2/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Nervous system disorders Orthostatic intolerance	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Infections and infestations Otitis externa	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Musculoskeletal and connective tissue disorders Pain in extremity	16.7% 2/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Musculoskeletal and connective tissue disorders Pain in jaw	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Infections and infestations Paronychia	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Infections and infestations Periodontitis	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Investigations Platelet count decreased	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Nervous system disorders Post herpetic neuralgia	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Infections and infestations Post-acute COVID-19 syndrome	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Injury, poisoning and procedural complications Post-traumatic pain	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Injury, poisoning and procedural complications Procedural dizziness	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Injury, poisoning and procedural complications Procedural pain	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Skin and subcutaneous tissue disorders Prurigo	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Infections and infestations Pulpitis dental	16.7% 2/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
General disorders Puncture site pain	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
General disorders Pyrexia	41.7% 5/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Skin and subcutaneous tissue disorders Rash	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Skin and subcutaneous tissue disorders Rash pruritic	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Nervous system disorders Retrograde amnesia	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Infections and infestations Rhinovirus infection	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Immune system disorders Seasonal allergy	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	16.7% 2/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Nervous system disorders Sinus headache	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Infections and infestations Sinusitis	33.3% 4/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Injury, poisoning and procedural complications Skin abrasion	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Injury, poisoning and procedural complications Skin injury	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	16.7% 2/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Gastrointestinal disorders Stomatitis	16.7% 2/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Ear and labyrinth disorders Sudden hearing loss	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Gastrointestinal disorders Tooth resorption	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Gastrointestinal disorders Toothache	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Infections and infestations Upper respiratory tract infection	16.7% 2/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Skin and subcutaneous tissue disorders Urticaria	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Injury, poisoning and procedural complications Vaccination complication	41.7% 5/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
General disorders Vaccination site joint erythema	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
General disorders Vaccination site pain	16.7% 2/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Ear and labyrinth disorders Vertigo	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Ear and labyrinth disorders Vertigo positional	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
Injury, poisoning and procedural complications Wound	8.3% 1/12 • From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: TrialDisclosures@takeda.com

Results disclosure agreements

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

Restriction type: OTHER