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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1155-5857 | Registry Identifier | WHO | |
| 2013-004210-18 | EudraCT Number | ||
| 14/LO/1070 | Registry Identifier | NRES |
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The purpose of this study is to characterize the pharmacokinetic and safety and tolerability profile of TAK-079 following a single intravenous (IV) infusion or subcutaneous (SC) administration at escalating dose levels in healthy participants.
The drug being tested in this study is TAK-079. TAK-079 is being tested to find a safe and well-tolerated dose and to assess how TAK-079 is processed by the body. This study will look at pharmacokinetics, side effects, and laboratory results in people who take TAK-079 and is designed as a randomized single dose-rising study.
Therefore, each subsequent cohort will not start until the previous cohort has completed and the results are reviewed. Each participant will receive TAK-079 or placebo once only as an IV infusion or by SC administration. The starting dose for IV will be 0.0003 mg/kg and SC dose of 0.01 or 0.03 mg/kg was determined based on the no-observed-adverse-effect-level (NOAEL) results from the 13-week good laboratory practice (GLP) monkey toxicology study. If this dose is well-tolerated, the next group will receive a higher dose, etc, until a maximal tolerated dose is reached with the highest dose not to exceed 1.0 mg/kg.
This single-center trial will be conducted in the United Kingdom. The overall time to participate in this study is up to 17 weeks. Participants will make 11 visits to the clinic, including one 10-day period of confinement in the clinic. All participants will be contacted by telephone 14 days after the last visit to the clinic for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: TAK-079 0.0003 mg/kg | Experimental | TAK-079 0.0003 mg/kg, infusion, intravenously, once. |
|
| Cohort 2-9: TAK-079 TBD | Experimental | TAK-079, infusion, intravenously or subcutaneously, once. Dose to be determined from data collected in previous IV or SC Cohort(s) |
|
| Placebo to TAK-079 | Placebo Comparator | Placebo to TAK-079, infusion, intravenously or subcutaneously, once. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-079 | Drug | TAK-079 solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE was assessed according to severity; mild (transient and easily tolerated by the participant), moderate (causes the participant discomfort and interrupts the participant's usual activities) and severe (causes considerable interference with the participant's usual activities). | First dose up to Day 94 |
| Number of Participants Who Meet the Takeda Development Centre (TDC) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose | First dose up to Day 78 | |
| Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | First dose up to Day 78 | |
| Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose | First dose up to Day 78 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Serum Concentration for TAK-079 | Day 1 pre-dose and at multiple time-points (up to Day 78) post-dose | |
| AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-079 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London | London | United Kingdom | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32045493 | Derived | Fedyk ER, Zhao L, Koch A, Smithson G, Estevam J, Chen G, Lahu G, Roepcke S, Lin J, Mclean L. Safety, tolerability, pharmacokinetics and pharmacodynamics of the anti-CD38 cytolytic antibody TAK-079 in healthy subjects. Br J Clin Pharmacol. 2020 Jul;86(7):1314-1325. doi: 10.1111/bcp.14241. Epub 2020 Feb 22. |
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Healthy participants were enrolled in 1 of 12 treatment groups to receive: TAK-079 placebo, 0.0003, 0.001, 0.003, 0.01, 0.03, 0.06 milligram per kilogram (mg/kg) Intravenously (IV) and TAK-079 placebo, 0.03, 0.1, 0.3, 0.6 mg/kg subcutaneously (SC).
Participants took part in the study at 1 investigative site in the United Kingdom (UK) from 01 August 2014 to 29 April 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | TAK-079 Pooled Placebo IV | TAK-079 placebo-matching, infusion solution, IV, once on Day 1. |
| FG001 | TAK-079 0.0003 mg/kg IV | TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1. |
| FG002 | TAK-079 0.001 mg/kg IV | TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1. |
| FG003 | TAK-079 0.003 mg/kg IV | TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1. |
| FG004 | TAK-079 0.01 mg/kg IV | TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1. |
| FG005 | TAK-079 0.03 mg/kg IV | TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1. |
| FG006 | TAK-079 0.06 mg/kg IV | TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1. |
| FG007 | TAK-079 Pooled Placebo SC | TAK-079 placebo-matching, infusion solution, SC, once on Day 1. |
| FG008 | TAK-079 0.03 mg/kg SC | TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1. |
| FG009 | TAK-079 0.1 mg/kg SC | TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1 |
| FG010 | TAK-079 0.3 mg/kg SC | TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1. |
| FG011 | TAK-079 0.6 mg/kg SC | TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) including those who did not complete all scheduled study visits.
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| ID | Title | Description |
|---|---|---|
| BG000 | TAK-079 Pooled Placebo IV | TAK-079 placebo-matching, infusion solution, IV, once on Day 1. |
| BG001 | TAK-079 0.0003 mg/kg IV | TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1. |
| 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 | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE was assessed according to severity; mild (transient and easily tolerated by the participant), moderate (causes the participant discomfort and interrupts the participant's usual activities) and severe (causes considerable interference with the participant's usual activities). | The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits. | Posted | Number | participants | First dose up to Day 94 |
|
Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 94 days after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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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-079 Pooled Placebo IV | TAK-079 placebo-matching, infusion solution, IV, once on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
Not provided
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| Placebo to TAK-079 |
| Drug |
Placebo to TAK-079 solution |
|
| Day 1 pre-dose and at multiple time points (up to Day 78) post-dose |
| AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-079 | Day 1 pre-dose and at multiple time-points (up to Day 78) post-dose |
| Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab) | Results for ADA analysis were reported. | Baseline up to Day 78 |
| Headington |
| Oxford |
| United Kingdom |
| BG002 | TAK-079 0.001 mg/kg IV | TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1. |
| BG003 | TAK-079 0.003 mg/kg IV | TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1. |
| BG004 | TAK-079 0.01 mg/kg IV | TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1. |
| BG005 | TAK-079 0.03 mg/kg IV | TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1. |
| BG006 | TAK-079 0.06 mg/kg IV | TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1. |
| BG007 | TAK-079 Pooled Placebo SC | TAK-079 placebo-matching, infusion solution, SC, once on Day 1. |
| BG008 | TAK-079 0.03 mg/kg SC | TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1. |
| BG009 | TAK-079 0.1 mg/kg SC | TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1 |
| BG010 | TAK-079 0.3 mg/kg SC | TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1. |
| BG011 | TAK-079 0.6 mg/kg SC | TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1. |
| BG012 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Smoking Classification | Number | participants |
|
| Caffeine Classification | Number | participants |
|
| Alcohol Classification | Number | participants |
|
| Height | Mean | Standard Deviation | centimeter (cm) |
|
| Weight | Mean | Standard Deviation | kilogram (kg) |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
|
| TAK-079 Pooled Placebo IV |
TAK-079 placebo-matching, infusion solution, IV, once on Day 1. |
| OG001 | TAK-079 0.0003 mg/kg IV | TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1. |
| OG002 | TAK-079 0.001 mg/kg IV | TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1. |
| OG003 | TAK-079 0.003 mg/kg IV | TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1. |
| OG004 | TAK-079 0.01 mg/kg IV | TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1. |
| OG005 | TAK-079 0.03 mg/kg IV | TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1. |
| OG006 | TAK-079 0.06 mg/kg IV | TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1. |
| OG007 | TAK-079 Pooled Placebo SC | TAK-079 placebo-matching, infusion solution, SC, once on Day 1. |
| OG008 | TAK-079 0.03 mg/kg SC | TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1. |
| OG009 | TAK-079 0.1 mg/kg SC | TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1 |
| OG010 | TAK-079 0.3 mg/kg SC | TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1. |
| OG011 | TAK-079 0.6 mg/kg SC | TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1. |
|
|
| Primary | Number of Participants Who Meet the Takeda Development Centre (TDC) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose | The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits. | Posted | Number | participants | First dose up to Day 78 |
|
|
|
| Secondary | Cmax: Maximum Observed Serum Concentration for TAK-079 | The pharmacokinetic(PK) analysis set included all participants who received study drug and had at least 1 measurable serum concentration of TAK-079. PK analysis was performed for TAK-079 0.03, 0.06 mg/kg IV and 0.6 SC mg/kg dose groups only, since serum concentrations of TAK-079 were below the LLOQ at all PK sampling time-points for remaining arms. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Day 1 pre-dose and at multiple time-points (up to Day 78) post-dose |
|
|
|
| Secondary | AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-079 | The PK analysis set:all participants who received study drug and had at least 1 measurable serum concentration of TAK-079.A valid AUClast was derived for TAK-079 0.6 mg/kgSC dose group only, since serum concentrations of TAK-079 were either below the LLOQ at all PK sampling time-points or too limited to estimate AUClast reliably for remaining arms. | Posted | Mean | Standard Deviation | nanogram*day per milliliter (ng*day/mL) | Day 1 pre-dose and at multiple time points (up to Day 78) post-dose |
|
|
|
| Secondary | AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-079 | The PK analysis set included all participants who received study drug and had at least 1 measurable serum concentration of TAK-079. PK analysis was performed for TAK-079 0.6 mg/kg SC dose groups only, since serum concentrations of TAK-079 were below the LLOQ at all PK sampling time-points for remaining arms. | Posted | Mean | Standard Deviation | ng*day/mL | Day 1 pre-dose and at multiple time-points (up to Day 78) post-dose |
|
|
|
| Secondary | Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab) | Results for ADA analysis were reported. | The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits. Due to change in planned analysis testing of NAb activity of ADA positive samples was not analysed. | Posted | Number | percentage of participants | Baseline up to Day 78 |
|
|
|
| Primary | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits. | Posted | Number | participants | First dose up to Day 78 |
|
|
|
| Primary | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose | The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits. | Posted | Number | participants | First dose up to Day 78 |
|
|
|
| 0 |
| 12 |
| 11 |
| 12 |
| EG001 | TAK-079 0.0003 mg/kg IV | TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1. | 0 | 4 | 3 | 4 |
| EG002 | TAK-079 0.001 mg/kg IV | TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1. | 0 | 4 | 3 | 4 |
| EG003 | TAK-079 0.003 mg/kg IV | TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1. | 0 | 4 | 3 | 4 |
| EG004 | TAK-079 0.01 mg/kg IV | TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1. | 0 | 6 | 6 | 6 |
| EG005 | TAK-079 0.03 mg/kg IV | TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1. | 0 | 6 | 6 | 6 |
| EG006 | TAK-079 0.06 mg/kg IV | TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1. | 0 | 6 | 6 | 6 |
| EG007 | TAK-079 Pooled Placebo SC | TAK-079 placebo-matching, infusion solution, SC, once on Day 1. | 0 | 8 | 6 | 8 |
| EG008 | TAK-079 0.03 mg/kg SC | TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1. | 0 | 6 | 6 | 6 |
| EG009 | TAK-079 0.1 mg/kg SC | TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1 | 0 | 6 | 6 | 6 |
| EG010 | TAK-079 0.3 mg/kg SC | TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1. | 0 | 6 | 5 | 6 |
| EG011 | TAK-079 0.6 mg/kg SC | TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1. | 0 | 6 | 5 | 6 |
| Eye irritation | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Faeces soft | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Catheter site bruise | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Feeling cold | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Catheter site phlebitis | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Catheter site related reaction | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Instillation site bruise | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Epididymitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
|
| Initial insomnia | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
|
| Oliguria | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Discomfort | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Tonsillar inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.