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The main aim of this study is to understand how the body absorbs, processes, and removes (known as pharmacokinetics or PK) TAK-881 and HyQvia, after they are given as a single injection under the skin in healthy adults.
Study participants will receive a single dose of TAK-881 or HyQvia on Day 1.
During the study, participants will need to stay at the clinic for 8 days followed by 8 ambulatory follow up visits till Day 85.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-881 1.0 g/kg | Experimental | Participants will receive TAK-881, 1.0 gram per Kilogram (g/kg), single subcutaneous (SC) injection using investigational needle sets on Day 1. |
|
| HyQvia 1g/kg | Experimental | Participants will receive HyQvia, 1.0 g/kg, single SC injection using investigational needle sets on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-881 | Biological | Participants will receive SC infusion of TAK-881. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline-corrected Area Under the Concentration-time Curve (AUC) From Day 1 to Day 29 (AUC Day 1-29) Based on Serum Total Immunoglobulin G (IgG) Levels | Baseline-corrected AUC Day 1-29 based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration. | Day 1 up to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline-uncorrected Maximum Observed Concentration (Cmax) Based on Serum Total IgG Levels | Baseline-uncorrected Cmax based on serum total IgG levels was reported for TAK-881 and HyQvia. | Day 1 up to Day 85 |
| Baseline-uncorrected Time to Maximum Concentration (Tmax) Based on Serum Total IgG Levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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| Label | URL |
|---|---|
| Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed. | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
A total of 30 participants were enrolled and received study treatment.
This study was conducted at single center in the United States from 24 March 2025 to 8 August 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | TAK-881 1.0 g/kg | Healthy participants received a single dose of TAK-881, 1.0 gram per kilogram (g/kg) subcutaneously (SC) using an investigational needle set on Day 1 and were followed through Day 85. |
| FG001 | HyQvia 1.0 g/kg | Healthy participants received a single dose of HyQvia 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set included all participants who received any amount of TAK-881 or HyQvia.
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| ID | Title | Description |
|---|---|---|
| BG000 | TAK-881 1.0 g/kg | Healthy participants received a single dose of TAK-881, 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85. |
| BG001 | HyQvia 1.0 g/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Baseline-corrected Area Under the Concentration-time Curve (AUC) From Day 1 to Day 29 (AUC Day 1-29) Based on Serum Total Immunoglobulin G (IgG) Levels | Baseline-corrected AUC Day 1-29 based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration. | The PKPPAS included all participants who had no protocol violations that affect the reliability of the total IgG pharmacokinetic (PK) profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | gram*hour per liter (g*h/L) | Day 1 up to Day 29 |
|
From start of study drug up to end of trial (up to Day 85)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TAK-881 1.0 g/kg | Healthy participants received a single dose of TAK-881, 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 18, 2025 | Apr 17, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 8, 2025 | Apr 17, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005719 | gamma-Globulins |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
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| HyQvia | Biological | Participants will receive SC infusion of HyQvia. |
|
|
| SC Investigational Needle Sets | Device | The single-use only SC needle set will be used to administer TAK-881 to the target depth below the skin surface. One needle set (single or bifurcated) will be used per infusion. |
|
| SC Investigational Needle Sets | Device | The single-use only SC needle set will be used to administer HyQvia to the target depth below the skin surface. One needle set (single or bifurcated) will be used per infusion. |
|
Baseline-uncorrected Tmax based on serum total IgG levels was reported for TAK-881 and HyQvia. |
| Day 1 up to Day 85 |
| Baseline-uncorrected AUC Day1-29 Based on Serum Total IgG Levels | Baseline-uncorrected AUC Day1-29 based on serum total IgG levels was reported for TAK-881 and HyQvia. | Day 1 up to Day 29 |
| Baseline-corrected AUC From Day 1 to Infinity (AUCinf) Based on Serum Total IgG Levels | Baseline-corrected AUCinf based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration. | Day 1 up to Day 85 |
| Baseline-corrected AUC From Day 1 to Time of the Last Measurable Concentration (AUClast) Based on Serum Total IgG Levels | Baseline-corrected AUClast based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration. | Day 1 up to Day 85 |
| Baseline-corrected Cmax Based on Serum Total IgG Levels | Baseline-corrected Cmax based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration. | Day 1 up to Day 85 |
| Baseline-corrected Tmax Based on Serum Total IgG Levels | Baseline-corrected Tmax based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration. | Day 1 up to Day 85 |
| Baseline-corrected Time of Last Measurable Concentration (Tlast) Based on Serum Total IgG Levels | Baseline-corrected Tlast based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration. | From Day 1 up to Day 85 |
| Baseline-corrected Terminal Half-life (t1/2z) Based on Serum Total IgG Levels | Baseline-corrected t1/2z based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration. | Day 1 up to Day 85 |
| Baseline-corrected Apparent Clearance (CL/F) Based on Serum Total IgG Levels | Baseline-corrected CL/F based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration. | Day 1 up to Day 85 |
| Baseline-corrected Apparent Volume of Distribution (Vz/F) Based on Serum Total IgG Levels | Baseline-corrected Vz/F based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration. | Day 1 up to Day 85 |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An Adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as any AE that was starting or worsening at the time of or after dosing of investigational product (IP). | From start of study drug up to end of trial (up to Day 85) |
| Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions | The number of participants with infusion withdrawals, interruptions, and infusion rate reductions due to TAK-881 or HyQvia related TEAEs were reported. | On Day 1 (day of the first and only infusion) |
| Number of Participants With Positive Binding Antibodies to rHuPH20 | Number of participants with positive binding antibodies to recombinant human hyaluronidase (rHuPH20) with titer greater than or equal to (>=) 1:160 were reported. | At Days -1, 29, and 85 |
| Number of Participants With Neutralizing Antibodies to rHuPH20 | Number of participants with neutralizing antibodies to rHuPH20 were reported. | At Days -1, 29, and 85 |
| Withdrawal by Subject |
|
Healthy participants received a single dose of HyQvia 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| HyQvia 1.0 g/kg |
Healthy participants received a single dose of HyQvia 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85. |
|
|
|
| Secondary | Baseline-uncorrected Maximum Observed Concentration (Cmax) Based on Serum Total IgG Levels | Baseline-uncorrected Cmax based on serum total IgG levels was reported for TAK-881 and HyQvia. | The PKPPAS included all participants who had no protocol violations that affect the reliability of the total IgG PK profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | gram per liter (g/L) | Day 1 up to Day 85 |
|
|
|
| Secondary | Baseline-uncorrected Time to Maximum Concentration (Tmax) Based on Serum Total IgG Levels | Baseline-uncorrected Tmax based on serum total IgG levels was reported for TAK-881 and HyQvia. | The PKPPAS included all participants who had no protocol violations that affect the reliability of the total IgG PK profiles. | Posted | Median | Full Range | hours | Day 1 up to Day 85 |
|
|
|
| Secondary | Baseline-uncorrected AUC Day1-29 Based on Serum Total IgG Levels | Baseline-uncorrected AUC Day1-29 based on serum total IgG levels was reported for TAK-881 and HyQvia. | The PKPPAS included all participants who had no protocol violations that affect the reliability of the total IgG PK profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | g*h/L | Day 1 up to Day 29 |
|
|
|
| Secondary | Baseline-corrected AUC From Day 1 to Infinity (AUCinf) Based on Serum Total IgG Levels | Baseline-corrected AUCinf based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration. | The PKPPAS included all participants who had no protocol violations that affect the reliability of the total IgG PK profiles. Here, "Overall number analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | g*h/L | Day 1 up to Day 85 |
|
|
|
| Secondary | Baseline-corrected AUC From Day 1 to Time of the Last Measurable Concentration (AUClast) Based on Serum Total IgG Levels | Baseline-corrected AUClast based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration. | The PKPPAS included all participants who had no protocol violations that affect the reliability of the total IgG PK profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | g*h/L | Day 1 up to Day 85 |
|
|
|
| Secondary | Baseline-corrected Cmax Based on Serum Total IgG Levels | Baseline-corrected Cmax based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration. | The PKPPAS included all participants who had no protocol violations that affect the reliability of the total IgG PK profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | g/L | Day 1 up to Day 85 |
|
|
|
| Secondary | Baseline-corrected Tmax Based on Serum Total IgG Levels | Baseline-corrected Tmax based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration. | The PKPPAS included all participants who had no protocol violations that affect the reliability of the total IgG PK profiles. | Posted | Median | Full Range | hours | Day 1 up to Day 85 |
|
|
|
| Secondary | Baseline-corrected Time of Last Measurable Concentration (Tlast) Based on Serum Total IgG Levels | Baseline-corrected Tlast based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration. | The PKPPAS included all participants who had no protocol violations that affect the reliability of the total IgG PK profiles. | Posted | Median | Full Range | hours | From Day 1 up to Day 85 |
|
|
|
| Secondary | Baseline-corrected Terminal Half-life (t1/2z) Based on Serum Total IgG Levels | Baseline-corrected t1/2z based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration. | The PKPPAS included all participants who had no protocol violations that affect the reliability of the total IgG PK profiles. Here, "Overall number analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Median | Full Range | hours | Day 1 up to Day 85 |
|
|
|
| Secondary | Baseline-corrected Apparent Clearance (CL/F) Based on Serum Total IgG Levels | Baseline-corrected CL/F based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration. | The PKPPAS included all participants who had no protocol violations that affect the reliability of the total IgG PK profiles. Here, "Overall number analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | liter per hour (L/h) | Day 1 up to Day 85 |
|
|
|
| Secondary | Baseline-corrected Apparent Volume of Distribution (Vz/F) Based on Serum Total IgG Levels | Baseline-corrected Vz/F based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration. | The PKPPAS included all participants who had no protocol violations that affect the reliability of the total IgG PK profiles. Here, "Overall number analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Liters (L) | Day 1 up to Day 85 |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An Adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as any AE that was starting or worsening at the time of or after dosing of investigational product (IP). | Safety analysis set included all participants who received any amount of TAK-881 or HyQvia. | Posted | Count of Participants | Participants | From start of study drug up to end of trial (up to Day 85) |
|
|
|
| Secondary | Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions | The number of participants with infusion withdrawals, interruptions, and infusion rate reductions due to TAK-881 or HyQvia related TEAEs were reported. | Safety analysis set included all participants who received any amount of TAK-881 or HyQvia. | Posted | Count of Participants | Participants | On Day 1 (day of the first and only infusion) |
|
|
|
| Secondary | Number of Participants With Positive Binding Antibodies to rHuPH20 | Number of participants with positive binding antibodies to recombinant human hyaluronidase (rHuPH20) with titer greater than or equal to (>=) 1:160 were reported. | Safety analysis set included all participants who received any amount of TAK-881 or HyQvia. | Posted | Count of Participants | Participants | At Days -1, 29, and 85 |
|
|
|
| Secondary | Number of Participants With Neutralizing Antibodies to rHuPH20 | Number of participants with neutralizing antibodies to rHuPH20 were reported. | Safety analysis set included all participants who received any amount of TAK-881 or HyQvia. | Posted | Count of Participants | Participants | At Days -1, 29, and 85 |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 15 |
| 15 |
| EG001 | HyQvia 1.0 g/kg | Healthy participants received a single dose of HyQvia 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85. | 0 | 15 | 0 | 15 | 15 | 15 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Breast tenderness | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Eyelid function disorder | Eye disorders | MedDRA 28.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Feeling cold | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Infusion site discolouration | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Infusion site discomfort | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Infusion site erythema | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Infusion site hypoaesthesia | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Infusion site induration | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Infusion site pain | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Infusion site pallor | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Infusion site papule | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Infusion site pruritus | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Infusion site swelling | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Infusion site warmth | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
| Low density lipoprotein increased | Investigations | MedDRA 28.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 28.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 28.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
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| D000602 |
| Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004364 | Pharmaceutical Preparations |
| At Day 85 |
|
| At Day 85 |
|