Trial Outcomes & Findings for A Study to Evaluate the Long-term Safety of TAK-771 in Japanese Primary Immunodeficiency Disease (PID) Participants (NCT NCT05513586)
NCT ID: NCT05513586
Last Updated: 2026-05-19
Results Overview
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. An AE can therefore be any unfavorable and unintended sign (including a clinically significant laboratory finding), symptom, or disease temporally associated with the use of a investigational product, whether or not causality is suspected. A TEAE was defined as any event emerging or manifesting at or after the initiation of treatment with an investigational product or medicinal product or any existing event that worsened in either intensity or frequency following exposure to the investigational product.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
15 participants
Primary outcome timeframe
From start of study drug administration up to end of study (up to 3.1 years)
Results posted on
2026-05-19
Participant Flow
A total of 15 participants with primary immunodeficiency diseases (PID) took part in the study in Japan from 13 Sep 2022 to 30 Oct 2025.
Participants who completed the study TAK-771-3004 (NCT05150340) were enrolled in this extension study and continued to receive TAK-771.
Participant milestones
| Measure |
TAK-771
Participants continued TAK-771 (Immune Globulin Infusion \[IGI\] 10% + Recombinant Human Hyaluronidase \[rHuPH20\]) administration at the same dose and frequency they had in the Study TAK-771-3004 (NCT05150340) with dosing intervals of either 3 or 4 weeks, until the commercial TAK-771 becomes available at each study site or study termination. Participants received subcutaneous (SC) infusion of rHuPH20 solution first at a dose of 80 units per gram (U/g), followed by SC infusion of 10 percentage (%) IGI within 10 minutes of completion of the infusion of rHuPH20 solution. The dose of TAK-771 was adjusted to maintain the target immunoglobulin G (IgG) trough level of greater than or equal to (\>=) 5 gram per litre (g/L).
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
TAK-771
Participants continued TAK-771 (Immune Globulin Infusion \[IGI\] 10% + Recombinant Human Hyaluronidase \[rHuPH20\]) administration at the same dose and frequency they had in the Study TAK-771-3004 (NCT05150340) with dosing intervals of either 3 or 4 weeks, until the commercial TAK-771 becomes available at each study site or study termination. Participants received subcutaneous (SC) infusion of rHuPH20 solution first at a dose of 80 units per gram (U/g), followed by SC infusion of 10 percentage (%) IGI within 10 minutes of completion of the infusion of rHuPH20 solution. The dose of TAK-771 was adjusted to maintain the target immunoglobulin G (IgG) trough level of greater than or equal to (\>=) 5 gram per litre (g/L).
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
A Study to Evaluate the Long-term Safety of TAK-771 in Japanese Primary Immunodeficiency Disease (PID) Participants
Baseline characteristics by cohort
| Measure |
TAK-771
n=15 Participants
Participants continued TAK-771 (IGI 10% + rHuPH20) administration at the same dose and frequency they had in the Study TAK-771-3004 (NCT05150340) with dosing intervals of either 3 or 4 weeks, until the commercial TAK-771 becomes available at each study site or study termination. Participants received SC infusion of rHuPH20 solution first at a dose of 80 U/g, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution. The dose of TAK-771 was adjusted to maintain the target IgG trough level of \>=5 g/L.
|
|---|---|
|
Age, Continuous
|
22.7 years
STANDARD_DEVIATION 14.19 • n=30 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration up to end of study (up to 3.1 years)Population: EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
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. An AE can therefore be any unfavorable and unintended sign (including a clinically significant laboratory finding), symptom, or disease temporally associated with the use of a investigational product, whether or not causality is suspected. A TEAE was defined as any event emerging or manifesting at or after the initiation of treatment with an investigational product or medicinal product or any existing event that worsened in either intensity or frequency following exposure to the investigational product.
Outcome measures
| Measure |
TAK-771
n=15 Participants
Participants continued TAK-771 (IGI 10% + rHuPH20) administration at the same dose and frequency they had in the Study TAK-771-3004 (NCT05150340) with dosing intervals of either 3 or 4 weeks, until the commercial TAK-771 becomes available at each study site or study termination. Participants received SC infusion of rHuPH20 solution first at a dose of 80 U/g, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution. The dose of TAK-771 was adjusted to maintain the target IgG trough level of \>=5 g/L.
|
|---|---|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
100 percentage of participants
|
PRIMARY outcome
Timeframe: From start of study drug administration up to end of study (up to 3.1 years)Population: EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
Participants who developed anti-rHuPH20 binding antibody titers of \>=1:160 and neutralizing antibodies to rHuPH20 was reported.
Outcome measures
| Measure |
TAK-771
n=15 Participants
Participants continued TAK-771 (IGI 10% + rHuPH20) administration at the same dose and frequency they had in the Study TAK-771-3004 (NCT05150340) with dosing intervals of either 3 or 4 weeks, until the commercial TAK-771 becomes available at each study site or study termination. Participants received SC infusion of rHuPH20 solution first at a dose of 80 U/g, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution. The dose of TAK-771 was adjusted to maintain the target IgG trough level of \>=5 g/L.
|
|---|---|
|
Percentage of Participants Who Developed Anti-rHuPH20 Binding Antibody Titers of >=1:160 and Neutralizing Antibodies to rHuPH20
Anti-rHuPH20 Binding Antibody Titers of >=1:160
|
0 percentage of participants
|
|
Percentage of Participants Who Developed Anti-rHuPH20 Binding Antibody Titers of >=1:160 and Neutralizing Antibodies to rHuPH20
Neutralizing Antibodies
|
0 percentage of participants
|
Adverse Events
TAK-771
Serious events: 6 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TAK-771
n=15 participants at risk
Participants continued TAK-771 (IGI 10% + rHuPH20) administration at the same dose and frequency they had in the Study TAK-771-3004 (NCT05150340) with dosing intervals of either 3 or 4 weeks, until the commercial TAK-771 becomes available at each study site or study termination. Participants received SC infusion of rHuPH20 solution first at a dose of 80 U/g, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution. The dose of TAK-771 was adjusted to maintain the target IgG trough level of \>=5 g/L.
|
|---|---|
|
Endocrine disorders
Adrenal insufficiency
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Infections and infestations
COVID-19
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Eye disorders
Eyelid ptosis
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
Other adverse events
| Measure |
TAK-771
n=15 participants at risk
Participants continued TAK-771 (IGI 10% + rHuPH20) administration at the same dose and frequency they had in the Study TAK-771-3004 (NCT05150340) with dosing intervals of either 3 or 4 weeks, until the commercial TAK-771 becomes available at each study site or study termination. Participants received SC infusion of rHuPH20 solution first at a dose of 80 U/g, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution. The dose of TAK-771 was adjusted to maintain the target IgG trough level of \>=5 g/L.
|
|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
General disorders
Administration site erythema
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
General disorders
Administration site pruritus
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Psychiatric disorders
Anxiety disorder
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
2/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
13.3%
2/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Infections and infestations
COVID-19
|
40.0%
6/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Infections and infestations
Conjunctivitis
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Eye disorders
Conjunctivitis allergic
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Gastrointestinal disorders
Dental caries
|
13.3%
2/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Gastrointestinal disorders
Enteritis
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Gastrointestinal disorders
Gastric polyps
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Infections and infestations
Gastroenteritis
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Gastrointestinal disorders
Gingival pain
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Nervous system disorders
Headache
|
20.0%
3/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Gastrointestinal disorders
Hiatus hernia
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Infections and infestations
Hordeolum
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Infections and infestations
Influenza
|
26.7%
4/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
General disorders
Infusion site erythema
|
13.3%
2/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
General disorders
Infusion site swelling
|
13.3%
2/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
General disorders
Injection site erythema
|
26.7%
4/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
General disorders
Injection site induration
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
General disorders
Injection site pain
|
26.7%
4/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
General disorders
Injection site pruritus
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
General disorders
Injection site reaction
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
General disorders
Injection site swelling
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Eye disorders
Keratitis interstitial
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Gastrointestinal disorders
Large intestine polyp
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Gastrointestinal disorders
Lip dry
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Investigations
Liver function test increased
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
General disorders
Malaise
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Infections and infestations
Nasopharyngitis
|
60.0%
9/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Reproductive system and breast disorders
Oedema genital
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Infections and infestations
Oral herpes
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Infections and infestations
Otitis externa
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Infections and infestations
Pharyngitis
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Infections and infestations
Pneumonia
|
13.3%
2/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
General disorders
Pyrexia
|
46.7%
7/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.3%
2/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Infections and infestations
Rhinitis
|
13.3%
2/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Injury, poisoning and procedural complications
Scratch
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Immune system disorders
Seasonal allergy
|
13.3%
2/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Nervous system disorders
Sensory disturbance
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Infections and infestations
Sinusitis
|
13.3%
2/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Gastrointestinal disorders
Stomatitis
|
13.3%
2/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
General disorders
Thirst
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Infections and infestations
Tinea versicolour
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
3/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
13.3%
2/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place