Trial Outcomes & Findings for A Comparison of the Safety and Immunogenicity of Various Schedules of Dengue Vaccine in Healthy Adult Volunteers (NCT NCT01542632)

NCT ID: NCT01542632

Last Updated: 2019-07-18

Results Overview

Erythema and Edema Were Graded Per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Where Grade 0=none to Grade 4=Severe. Pain and Itching were graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where Grade 0=no pain or itching to Grade 4= Life-threatening/severe. Only those score categories for which there was at least 1 participant are reported.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 140 participants
• Primary outcome timeframe: Day 0 to Day 104
• Results posted on: 2019-07-18

Participant Flow

Participants took part in the study at 3 investigative sites in the United States from 23 January 2012 to 10 January 2014.

Participants were enrolled in 1 of 6 treatment groups (GRP). GRP1: 1 dose TDV on Day 0 and 90, GRP2: 2 doses of TDV on Day 0, GRP3: 2 Doses of TDV on Day 0 and 1 dose of TDV on Day 90, GRP4: 1 Dose of TDV New Formula on Day 0 and 90, GRP5: 2 doses of TDV New Formula on Day 0 and 90 and GRP6: 1/10 dose of TDV on Day 0 and 90.

Participant milestones

Measure	Group 1 (D0:TDV,P D90:TDV) Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).	Group 2 (D0:TDV,TDV D90:P) TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.	Group 3 (D0:TDV,TDV D90:TDV) TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.	Group 4 (D0:TDVN,P D90:TDVN,P) TDV new formulation(TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.	Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.	Group 6 (D0:1/10TDV D90:1/10TDV) 1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
Overall Study STARTED	25	25	24	21	21	24
Overall Study COMPLETED	25	24	23	19	17	24
Overall Study NOT COMPLETED	0	1	1	2	4	0

Reasons for withdrawal

Measure	Group 1 (D0:TDV,P D90:TDV) Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).	Group 2 (D0:TDV,TDV D90:P) TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.	Group 3 (D0:TDV,TDV D90:TDV) TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.	Group 4 (D0:TDVN,P D90:TDVN,P) TDV new formulation(TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.	Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.	Group 6 (D0:1/10TDV D90:1/10TDV) 1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
Overall Study Withdrawal of Consent	0	0	0	2	3	0
Overall Study Adverse Event	0	0	1	0	0	0
Overall Study Lost to Follow-up	0	1	0	0	0	0
Overall Study Sponsor/Investigator Decision	0	0	0	0	1	0

Baseline Characteristics

A Comparison of the Safety and Immunogenicity of Various Schedules of Dengue Vaccine in Healthy Adult Volunteers

Baseline characteristics by cohort

Measure	Group 1 (D0:TDV,P D90:TDV) n=25 Participants Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).	Group 2 (DO:TDV,TDV D90:P) n=25 Participants TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.	Group 3 (D0:TDV,TDV D90:TDV) n=24 Participants TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.	Group 4 (D0:TDVN,P D90:TDVN,P) n=21 Participants TDV new formulation(TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.	Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) n=21 Participants TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.	Group 6 (D0:1/10TDV D90:1/10TDV) n=24 Participants 1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.	Total n=140 Participants Total of all reporting groups
Age, Continuous	29.6 years STANDARD_DEVIATION 5.74 • n=5 Participants	28.2 years STANDARD_DEVIATION 6.36 • n=7 Participants	29.2 years STANDARD_DEVIATION 6.40 • n=5 Participants	30.0 years STANDARD_DEVIATION 6.67 • n=4 Participants	30.3 years STANDARD_DEVIATION 7.95 • n=21 Participants	32.5 years STANDARD_DEVIATION 6.04 • n=10 Participants	30.0 years STANDARD_DEVIATION 6.54 • n=115 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	14 Participants n=7 Participants	12 Participants n=5 Participants	8 Participants n=4 Participants	9 Participants n=21 Participants	9 Participants n=10 Participants	67 Participants n=115 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	13 Participants n=4 Participants	12 Participants n=21 Participants	15 Participants n=10 Participants	73 Participants n=115 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=10 Participants	2 participants n=115 Participants
Race/Ethnicity, Customized Black/African American	0 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	1 participants n=10 Participants	4 participants n=115 Participants
Race/Ethnicity, Customized Hawaiian/Pacific Islander	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	0 participants n=21 Participants	0 participants n=10 Participants	1 participants n=115 Participants
Race/Ethnicity, Customized Hispanic Or Latino	6 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants	0 participants n=4 Participants	2 participants n=21 Participants	0 participants n=10 Participants	18 participants n=115 Participants
Race/Ethnicity, Customized Other	2 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=10 Participants	3 participants n=115 Participants
Race/Ethnicity, Customized White	17 participants n=5 Participants	19 participants n=7 Participants	14 participants n=5 Participants	20 participants n=4 Participants	19 participants n=21 Participants	23 participants n=10 Participants	112 participants n=115 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	24 participants n=5 Participants	21 participants n=4 Participants	21 participants n=21 Participants	24 participants n=10 Participants	140 participants n=115 Participants
Weight	73.3 kg STANDARD_DEVIATION 11.66 • n=5 Participants	75.9 kg STANDARD_DEVIATION 13.22 • n=7 Participants	76.7 kg STANDARD_DEVIATION 15.76 • n=5 Participants	80.8 kg STANDARD_DEVIATION 14.12 • n=4 Participants	77.3 kg STANDARD_DEVIATION 14.91 • n=21 Participants	81.7 kg STANDARD_DEVIATION 16.02 • n=10 Participants	77.5 kg STANDARD_DEVIATION 14.36 • n=115 Participants
Height	1.71 m STANDARD_DEVIATION 0.092 • n=5 Participants	1.71 m STANDARD_DEVIATION 0.084 • n=7 Participants	1.70 m STANDARD_DEVIATION 0.108 • n=5 Participants	1.76 m STANDARD_DEVIATION 0.105 • n=4 Participants	1.73 m STANDARD_DEVIATION 0.099 • n=21 Participants	1.75 m STANDARD_DEVIATION 0.104 • n=10 Participants	1.72 m STANDARD_DEVIATION 0.100 • n=115 Participants
Body Mass Index (BMI)	24.81 kg/m^2 STANDARD_DEVIATION 2.423 • n=5 Participants	25.97 kg/m^2 STANDARD_DEVIATION 3.314 • n=7 Participants	26.50 kg/m^2 STANDARD_DEVIATION 3.735 • n=5 Participants	26.09 kg/m^2 STANDARD_DEVIATION 3.202 • n=4 Participants	25.81 kg/m^2 STANDARD_DEVIATION 3.712 • n=21 Participants	26.35 kg/m^2 STANDARD_DEVIATION 3.517 • n=10 Participants	25.91 kg/m^2 STANDARD_DEVIATION 3.323 • n=115 Participants

PRIMARY outcome

Timeframe: Day 0 to Day 104

Population: Safety population included all enrolled participants who received at least one dose of study drug.

Erythema and Edema Were Graded Per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Where Grade 0=none to Grade 4=Severe. Pain and Itching were graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where Grade 0=no pain or itching to Grade 4= Life-threatening/severe. Only those score categories for which there was at least 1 participant are reported.

Outcome measures

Measure	Group 1 (D0:TDV,P D90:TDV) n=25 Participants Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).	Group 2 (D0:TDV,TDV D90:P) n=25 Participants TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.	Group 3 (D0:TDV,TDV D90:TDV) n=24 Participants TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 1. TDV, 0.5 mL, subcutaneous injection on Day 90.	Group 4 (D0:TDVN,P D90:TDVN,P) n=21 Participants TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.	Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) n=21 Participants TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.	Group 6 (D0:1/10TDV D90:1/10TDV) n=24 Participants 1/10 TDV, 0.5 mL, subcutaneous injection on Days 1 and 90.
Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported Edema=0	25 participants	25 participants	24 participants	21 participants	21 participants	24 participants
Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported Erythema=0	25 participants	25 participants	24 participants	21 participants	21 participants	24 participants
Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported Itching=0	24 participants	19 participants	23 participants	20 participants	21 participants	22 participants
Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported Itching=1	1 participants	6 participants	1 participants	1 participants	0 participants	2 participants
Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported Pain=0	19 participants	18 participants	19 participants	16 participants	18 participants	20 participants
Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported Pain=1	6 participants	7 participants	4 participants	5 participants	2 participants	4 participants
Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported Pain=2	0 participants	0 participants	1 participants	0 participants	1 participants	0 participants

PRIMARY outcome

Timeframe: For 30 days after each dose (Up to Day 120)

Population: Safety Population included all enrolled participants who received at least one dose of study drug.

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. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.

Outcome measures

Measure	Group 1 (D0:TDV,P D90:TDV) n=25 Participants Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).	Group 2 (D0:TDV,TDV D90:P) n=25 Participants TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.	Group 3 (D0:TDV,TDV D90:TDV) n=24 Participants TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 1. TDV, 0.5 mL, subcutaneous injection on Day 90.	Group 4 (D0:TDVN,P D90:TDVN,P) n=21 Participants TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.	Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) n=21 Participants TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.	Group 6 (D0:1/10TDV D90:1/10TDV) n=24 Participants 1/10 TDV, 0.5 mL, subcutaneous injection on Days 1 and 90.
Number of Participants With at Least 1 Adverse Event Following Either Vaccine Dose	22 participants	19 participants	21 participants	17 participants	17 participants	18 participants

PRIMARY outcome

Timeframe: For 30 days after each dose (Up to Day 120)

Population: Safety Population included all enrolled participants who received at least one dose of study drug.

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. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. Some AEs are automatically considered related because of temporal relationship to vaccination.

Outcome measures

Measure	Group 1 (D0:TDV,P D90:TDV) n=25 Participants Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).	Group 2 (D0:TDV,TDV D90:P) n=25 Participants TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.	Group 3 (D0:TDV,TDV D90:TDV) n=24 Participants TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 1. TDV, 0.5 mL, subcutaneous injection on Day 90.	Group 4 (D0:TDVN,P D90:TDVN,P) n=21 Participants TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.	Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) n=21 Participants TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.	Group 6 (D0:1/10TDV D90:1/10TDV) n=24 Participants 1/10 TDV, 0.5 mL, subcutaneous injection on Days 1 and 90.
Number of Participants With at Least 1 Adverse Events Related to TDV Following Either Vaccine Dose	20 participants	16 participants	18 participants	14 participants	12 participants	14 participants

PRIMARY outcome

Timeframe: Up to 30 days after the last immunization (Up to Day 120)

Population: Participants from the Full Analysis Set, all enrolled participants, with data available at the given time-point.

Rate of seroconversion was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plagues (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline.

Outcome measures

Measure	Group 1 (D0:TDV,P D90:TDV) n=25 Participants Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).	Group 2 (D0:TDV,TDV D90:P) n=25 Participants TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.	Group 3 (D0:TDV,TDV D90:TDV) n=24 Participants TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 1. TDV, 0.5 mL, subcutaneous injection on Day 90.	Group 4 (D0:TDVN,P D90:TDVN,P) n=21 Participants TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.	Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) n=19 Participants TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.	Group 6 (D0:1/10TDV D90:1/10TDV) n=24 Participants 1/10 TDV, 0.5 mL, subcutaneous injection on Days 1 and 90.
Rate of Seroconversion to Each of Four Dengue Serotypes Dengue-1 Day 30 (n=25, 24, 24, 21, 19, 24)	100.0 percentage of participants	95.8 percentage of participants	100.0 percentage of participants	81.0 percentage of participants	89.5 percentage of participants	100.0 percentage of participants
Rate of Seroconversion to Each of Four Dengue Serotypes Dengue-2 Day 30 (n=25, 24, 24, 21, 19, 24)	96.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	95.8 percentage of participants
Rate of Seroconversion to Each of Four Dengue Serotypes Dengue-3 Day 30 (n=25, 24, 24, 21, 19, 24)	84.0 percentage of participants	100.0 percentage of participants	87.5 percentage of participants	85.7 percentage of participants	94.7 percentage of participants	66.7 percentage of participants
Rate of Seroconversion to Each of Four Dengue Serotypes Dengue-4 Day 30 (n=25, 24, 24, 21, 19, 24)	36.0 percentage of participants	58.3 percentage of participants	33.3 percentage of participants	81.0 percentage of participants	57.9 percentage of participants	29.2 percentage of participants
Rate of Seroconversion to Each of Four Dengue Serotypes Dengue-1 Day 90 (n=25, 24, 23, 20, 18, 24)	96.0 percentage of participants	91.7 percentage of participants	95.7 percentage of participants	75.0 percentage of participants	72.2 percentage of participants	87.5 percentage of participants
Rate of Seroconversion to Each of Four Dengue Serotypes Dengue-2 Day 90 (n=25, 24, 23, 20, 18, 24)	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	91.7 percentage of participants
Rate of Seroconversion to Each of Four Dengue Serotypes Dengue-3 Day 90 (n=25, 24, 23, 20, 18, 24)	80.0 percentage of participants	91.7 percentage of participants	82.6 percentage of participants	75.0 percentage of participants	83.3 percentage of participants	62.5 percentage of participants
Rate of Seroconversion to Each of Four Dengue Serotypes Dengue-4 Day 90 (n=25, 24, 23, 20, 18, 24)	24.0 percentage of participants	29.2 percentage of participants	21.7 percentage of participants	50.0 percentage of participants	38.9 percentage of participants	37.5 percentage of participants
Rate of Seroconversion to Each of Four Dengue Serotypes Dengue-1 Day 120 (n=25, 24, 23, 19, 17, 24)	100.0 percentage of participants	95.8 percentage of participants	95.7 percentage of participants	84.2 percentage of participants	94.1 percentage of participants	95.8 percentage of participants
Rate of Seroconversion to Each of Four Dengue Serotypes Dengue-2 Day 120 (n=25, 24, 23, 19, 17, 24)	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	95.8 percentage of participants
Rate of Seroconversion to Each of Four Dengue Serotypes Dengue-3 Day 120 (n=25, 24, 23, 19, 17, 24)	100.0 percentage of participants	95.8 percentage of participants	91.3 percentage of participants	94.7 percentage of participants	94.1 percentage of participants	83.3 percentage of participants
Rate of Seroconversion to Each of Four Dengue Serotypes Dengue-4 Day 120 (n=25, 24, 23, 19, 17, 24)	60.0 percentage of participants	33.3 percentage of participants	52.2 percentage of participants	73.7 percentage of participants	76.5 percentage of participants	41.7 percentage of participants

SECONDARY outcome

Timeframe: various timepoints up to 30 days after each dose (Up to Day 120)

Population: Full Analysis Set included all enrolled participants.

Serotype-Specific TDV Viral RNA was assessed for the four dengue serotypes: Dengue-1, Dengue-2, Dengue-3 and Dengue-4 . Only those serotypes and time-points where at least 1 participant had Serotype-Specific TDV Viral RNA Detected is reported.

Outcome measures

Measure	Group 1 (D0:TDV,P D90:TDV) n=25 Participants Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).	Group 2 (D0:TDV,TDV D90:P) n=25 Participants TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.	Group 3 (D0:TDV,TDV D90:TDV) n=24 Participants TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 1. TDV, 0.5 mL, subcutaneous injection on Day 90.	Group 4 (D0:TDVN,P D90:TDVN,P) n=21 Participants TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.	Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) n=21 Participants TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.	Group 6 (D0:1/10TDV D90:1/10TDV) n=24 Participants 1/10 TDV, 0.5 mL, subcutaneous injection on Days 1 and 90.
Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations Day 7 Dengue-2	20 percentage of participants	8 percentage of participants	12 percentage of participants	19 percentage of participants	19 percentage of participants	16 percentage of participants
Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations Day 9 Dengue-2	56 percentage of participants	72 percentage of participants	66 percentage of participants	47 percentage of participants	61 percentage of participants	45 percentage of participants
Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations Day 9 Dengue-3	0 percentage of participants	0 percentage of participants	0 percentage of participants	4 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations Day 11 Dengue-2	64 percentage of participants	68 percentage of participants	75 percentage of participants	61 percentage of participants	52 percentage of participants	70 percentage of participants
Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations Day 11 Dengue-3	0 percentage of participants	0 percentage of participants	0 percentage of participants	4 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations Day 11 Dengue-4	0 percentage of participants	0 percentage of participants	0 percentage of participants	4 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations Day 14 Dengue-2	52 percentage of participants	52 percentage of participants	66 percentage of participants	33 percentage of participants	28 percentage of participants	41 percentage of participants
Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations Day 17 Dengue-1	0 percentage of participants	0 percentage of participants	0 percentage of participants	4 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations Day 17 Dengue-2	24 percentage of participants	12 percentage of participants	8 percentage of participants	14 percentage of participants	0 percentage of participants	12 percentage of participants
Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations Day 21 Dengue-2	0 percentage of participants	0 percentage of participants	0 percentage of participants	4 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations Day 90 Dengue-3	0 percentage of participants	4 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Days 30, 90 and 120 after 1st vaccination

Population: Participants from the Full Analysis, all enrolled participants, with data available for analysis at the given time-point.

Outcome measures

Measure	Group 1 (D0:TDV,P D90:TDV) n=25 Participants Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).	Group 2 (D0:TDV,TDV D90:P) n=25 Participants TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.	Group 3 (D0:TDV,TDV D90:TDV) n=24 Participants TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 1. TDV, 0.5 mL, subcutaneous injection on Day 90.	Group 4 (D0:TDVN,P D90:TDVN,P) n=21 Participants TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.	Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) n=21 Participants TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.	Group 6 (D0:1/10TDV D90:1/10TDV) n=24 Participants 1/10 TDV, 0.5 mL, subcutaneous injection on Days 1 and 90.
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes Day 30 Dengue-1 (n=25, 24, 24, 21, 19, 24)	428.6 titer Standard Deviation 2.28	473.6 titer Standard Deviation 2.60	370.1 titer Standard Deviation 3.87	45.6 titer Standard Deviation 3.97	69.1 titer Standard Deviation 5.51	391.4 titer Standard Deviation 3.30
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes Day 30 Dengue-2 (n=25, 24, 24, 21, 19, 24)	6411.9 titer Standard Deviation 7.83	4843.3 titer Standard Deviation 3.42	6274.1 titer Standard Deviation 3.57	4953.8 titer Standard Deviation 3.01	5419.6 titer Standard Deviation 3.06	7315.3 titer Standard Deviation 5.90
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes Day 30 Dengue-3 (n=25, 24, 24, 21, 19, 24)	62.3 titer Standard Deviation 5.78	151.0 titer Standard Deviation 4.12	70.3 titer Standard Deviation 6.10	47.2 titer Standard Deviation 5.69	62.0 titer Standard Deviation 6.19	37.4 titer Standard Deviation 6.13
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes Day 30 Dengue-4 (n=25, 24, 24, 21, 19, 24)	8.2 titer Standard Deviation 2.20	19.4 titer Standard Deviation 4.65	11.6 titer Standard Deviation 5.00	45.6 titer Standard Deviation 5.13	21.5 titer Standard Deviation 5.89	17.4 titer Standard Deviation 10.28
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes Day 90 Dengue-1 (n=25, 24, 23, 20, 18, 23)	155.6 titer Standard Deviation 4.26	130.7 titer Standard Deviation 2.75	142.2 titer Standard Deviation 6.16	27.3 titer Standard Deviation 3.11	37.0 titer Standard Deviation 5.91	127.6 titer Standard Deviation 5.92
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes Day 90 Dengue-2 (n=25, 24, 23, 20, 18, 23)	1597.9 titer Standard Deviation 2.81	1758.7 titer Standard Deviation 3.29	1814.4 titer Standard Deviation 3.13	1383.1 titer Standard Deviation 2.82	1288.7 titer Standard Deviation 3.14	1756.5 titer Standard Deviation 5.80
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes Day 90 Dengue-3 (n=25, 24, 23, 20, 18, 23)	32.0 titer Standard Deviation 4.10	44.9 titer Standard Deviation 4.04	28.7 titer Standard Deviation 5.38	20.0 titer Standard Deviation 4.17	27.7 titer Standard Deviation 4.68	22.6 titer Standard Deviation 4.87
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes Day 90 Dengue-4 (n=25, 24, 23, 20, 18, 23)	6.6 titer Standard Deviation 1.76	10.3 titer Standard Deviation 3.44	9.4 titer Standard Deviation 3.62	13.7 titer Standard Deviation 3.60	11.2 titer Standard Deviation 3.62	13.5 titer Standard Deviation 6.85
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes Day 120 Dengue-1 (n=25, 24, 23, 19, 17, 24)	223.2 titer Standard Deviation 3.55	136.5 titer Standard Deviation 3.88	216.3 titer Standard Deviation 6.23	38.6 titer Standard Deviation 2.70	65.4 titer Standard Deviation 5.00	179.6 titer Standard Deviation 4.85
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes Day 120 Dengue-2 (n=25, 24, 23, 19, 17, 24)	1597.9 titer Standard Deviation 2.27	1478.9 titer Standard Deviation 2.72	1893.9 titer Standard Deviation 2.89	1631.8 titer Standard Deviation 3.49	1295.5 titer Standard Deviation 3.22	1356.1 titer Standard Deviation 5.37
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes Day 120 Dengue-3 (n=25, 24, 23, 19, 17, 24)	51.3 titer Standard Deviation 2.28	42.4 titer Standard Deviation 3.70	56.6 titer Standard Deviation 4.43	30.5 titer Standard Deviation 3.36	51.2 titer Standard Deviation 3.00	25.9 titer Standard Deviation 3.87
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes Day 120 Dengue-4 (n=25, 24, 23, 19, 17, 24)	11.5 titer Standard Deviation 2.50	8.9 titer Standard Deviation 2.70	12.0 titer Standard Deviation 3.58	23.2 titer Standard Deviation 3.52	25.5 titer Standard Deviation 3.74	12.8 titer Standard Deviation 5.81

Adverse Events

Group 1 (D0:TDV,P D90:TDV)

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Group 2 (D0:TDV,TDV D90:P)

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Group 3 (D0:TDV,TDV D90:TDV)

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Group 4 (D0:TDVN,P D90:TDVN,P)

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Group 6 (D0:1/10TDV D90:1/10TDV)

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Group 1 (D0:TDV,P D90:TDV) n=25 participants at risk Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).	Group 2 (D0:TDV,TDV D90:P) n=25 participants at risk TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.	Group 3 (D0:TDV,TDV D90:TDV) n=24 participants at risk TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.	Group 4 (D0:TDVN,P D90:TDVN,P) n=21 participants at risk TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.	Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) n=21 participants at risk TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.	Group 6 (D0:1/10TDV D90:1/10TDV) n=24 participants at risk 1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
General disorders Fatigue	52.0% 13/25 • Day 0 to Day 120 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.	44.0% 11/25 • Day 0 to Day 120 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.	37.5% 9/24 • Day 0 to Day 120 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.	47.6% 10/21 • Day 0 to Day 120 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.	47.6% 10/21 • Day 0 to Day 120 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.	29.2% 7/24 • Day 0 to Day 120 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.
General disorders Injection site haematoma	4.0% 1/25 • Day 0 to Day 120 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.	8.0% 2/25 • Day 0 to Day 120 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.	16.7% 4/24 • Day 0 to Day 120 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.	0.00% 0/21 • Day 0 to Day 120 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.	0.00% 0/21 • Day 0 to Day 120 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.	0.00% 0/24 • Day 0 to Day 120 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.
General disorders Pain	0.00% 0/25 • Day 0 to Day 120 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.	12.0% 3/25 • Day 0 to Day 120 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.	8.3% 2/24 • Day 0 to Day 120 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.	4.8% 1/21 • Day 0 to Day 120 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.	0.00% 0/21 • Day 0 to Day 120 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.	4.2% 1/24 • Day 0 to Day 120 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.
Nervous system disorders Headache	56.0% 14/25 • Day 0 to Day 120 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.	52.0% 13/25 • Day 0 to Day 120 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.	50.0% 12/24 • Day 0 to Day 120 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.	47.6% 10/21 • Day 0 to Day 120 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.	57.1% 12/21 • Day 0 to Day 120 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.	50.0% 12/24 • Day 0 to Day 120 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.
Musculoskeletal and connective tissue disorders Myalgia	32.0% 8/25 • Day 0 to Day 120 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.	32.0% 8/25 • Day 0 to Day 120 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.	33.3% 8/24 • Day 0 to Day 120 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.	19.0% 4/21 • Day 0 to Day 120 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.	38.1% 8/21 • Day 0 to Day 120 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.	16.7% 4/24 • Day 0 to Day 120 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.
Musculoskeletal and connective tissue disorders Arthralgia	16.0% 4/25 • Day 0 to Day 120 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.	20.0% 5/25 • Day 0 to Day 120 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.	20.8% 5/24 • Day 0 to Day 120 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.	4.8% 1/21 • Day 0 to Day 120 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.	23.8% 5/21 • Day 0 to Day 120 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.	25.0% 6/24 • Day 0 to Day 120 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.
Musculoskeletal and connective tissue disorders Back pain	4.0% 1/25 • Day 0 to Day 120 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.	8.0% 2/25 • Day 0 to Day 120 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.	0.00% 0/24 • Day 0 to Day 120 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.	0.00% 0/21 • Day 0 to Day 120 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.	4.8% 1/21 • Day 0 to Day 120 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.	0.00% 0/24 • Day 0 to Day 120 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.
Infections and infestations Upper respiratory tract infection	24.0% 6/25 • Day 0 to Day 120 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.	0.00% 0/25 • Day 0 to Day 120 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.	0.00% 0/24 • Day 0 to Day 120 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.	23.8% 5/21 • Day 0 to Day 120 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.	28.6% 6/21 • Day 0 to Day 120 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.	25.0% 6/24 • Day 0 to Day 120 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.
Infections and infestations Urinary tract infection	0.00% 0/25 • Day 0 to Day 120 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.	0.00% 0/25 • Day 0 to Day 120 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.	0.00% 0/24 • Day 0 to Day 120 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.	0.00% 0/21 • Day 0 to Day 120 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.	9.5% 2/21 • Day 0 to Day 120 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.	0.00% 0/24 • Day 0 to Day 120 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.
Gastrointestinal disorders Nausea	8.0% 2/25 • Day 0 to Day 120 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.	12.0% 3/25 • Day 0 to Day 120 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.	12.5% 3/24 • Day 0 to Day 120 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.	28.6% 6/21 • Day 0 to Day 120 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.	28.6% 6/21 • Day 0 to Day 120 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.	8.3% 2/24 • Day 0 to Day 120 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.
Gastrointestinal disorders Abdominal pain	4.0% 1/25 • Day 0 to Day 120 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.	8.0% 2/25 • Day 0 to Day 120 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.	0.00% 0/24 • Day 0 to Day 120 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.	0.00% 0/21 • Day 0 to Day 120 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.	0.00% 0/21 • Day 0 to Day 120 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.	0.00% 0/24 • Day 0 to Day 120 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.
Gastrointestinal disorders Abdominal pain upper	4.0% 1/25 • Day 0 to Day 120 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.	0.00% 0/25 • Day 0 to Day 120 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.	4.2% 1/24 • Day 0 to Day 120 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.	0.00% 0/21 • Day 0 to Day 120 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.	9.5% 2/21 • Day 0 to Day 120 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.	0.00% 0/24 • Day 0 to Day 120 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.
Gastrointestinal disorders Diarrhoea	4.0% 1/25 • Day 0 to Day 120 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.	4.0% 1/25 • Day 0 to Day 120 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.	4.2% 1/24 • Day 0 to Day 120 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.	9.5% 2/21 • Day 0 to Day 120 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.	0.00% 0/21 • Day 0 to Day 120 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.	4.2% 1/24 • Day 0 to Day 120 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.
Gastrointestinal disorders Dyspepsia	0.00% 0/25 • Day 0 to Day 120 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.	8.0% 2/25 • Day 0 to Day 120 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.	0.00% 0/24 • Day 0 to Day 120 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.	0.00% 0/21 • Day 0 to Day 120 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.	0.00% 0/21 • Day 0 to Day 120 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.	0.00% 0/24 • Day 0 to Day 120 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.
Gastrointestinal disorders Vomiting	0.00% 0/25 • Day 0 to Day 120 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.	0.00% 0/25 • Day 0 to Day 120 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.	8.3% 2/24 • Day 0 to Day 120 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.	4.8% 1/21 • Day 0 to Day 120 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.	0.00% 0/21 • Day 0 to Day 120 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.	0.00% 0/24 • Day 0 to Day 120 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.
Skin and subcutaneous tissue disorders Rash	16.0% 4/25 • Day 0 to Day 120 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.	12.0% 3/25 • Day 0 to Day 120 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.	8.3% 2/24 • Day 0 to Day 120 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.	14.3% 3/21 • Day 0 to Day 120 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.	19.0% 4/21 • Day 0 to Day 120 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.	8.3% 2/24 • Day 0 to Day 120 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.
Eye disorders Eye pain	8.0% 2/25 • Day 0 to Day 120 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.	12.0% 3/25 • Day 0 to Day 120 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.	8.3% 2/24 • Day 0 to Day 120 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.	23.8% 5/21 • Day 0 to Day 120 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.	19.0% 4/21 • Day 0 to Day 120 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.	16.7% 4/24 • Day 0 to Day 120 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.
Eye disorders Photophobia	8.0% 2/25 • Day 0 to Day 120 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.	12.0% 3/25 • Day 0 to Day 120 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.	8.3% 2/24 • Day 0 to Day 120 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.	14.3% 3/21 • Day 0 to Day 120 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.	23.8% 5/21 • Day 0 to Day 120 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.	20.8% 5/24 • Day 0 to Day 120 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.
Respiratory, thoracic and mediastinal disorders Sinus congestion	8.0% 2/25 • Day 0 to Day 120 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.	0.00% 0/25 • Day 0 to Day 120 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.	0.00% 0/24 • Day 0 to Day 120 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.	0.00% 0/21 • Day 0 to Day 120 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.	0.00% 0/21 • Day 0 to Day 120 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.	0.00% 0/24 • Day 0 to Day 120 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.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/25 • Day 0 to Day 120 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.	4.0% 1/25 • Day 0 to Day 120 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.	0.00% 0/24 • Day 0 to Day 120 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.	9.5% 2/21 • Day 0 to Day 120 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.	9.5% 2/21 • Day 0 to Day 120 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.	0.00% 0/24 • Day 0 to Day 120 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.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/25 • Day 0 to Day 120 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.	0.00% 0/25 • Day 0 to Day 120 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.	4.2% 1/24 • Day 0 to Day 120 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.	14.3% 3/21 • Day 0 to Day 120 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.	4.8% 1/21 • Day 0 to Day 120 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.	0.00% 0/24 • Day 0 to Day 120 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.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/25 • Day 0 to Day 120 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.	0.00% 0/25 • Day 0 to Day 120 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.	12.5% 3/24 • Day 0 to Day 120 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.	9.5% 2/21 • Day 0 to Day 120 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.	14.3% 3/21 • Day 0 to Day 120 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.	4.2% 1/24 • Day 0 to Day 120 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.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/25 • Day 0 to Day 120 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.	0.00% 0/25 • Day 0 to Day 120 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.	8.3% 2/24 • Day 0 to Day 120 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.	9.5% 2/21 • Day 0 to Day 120 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.	0.00% 0/21 • Day 0 to Day 120 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.	0.00% 0/24 • Day 0 to Day 120 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.
Immune system disorders Seasonal allergy	4.0% 1/25 • Day 0 to Day 120 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.	4.0% 1/25 • Day 0 to Day 120 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.	8.3% 2/24 • Day 0 to Day 120 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.	0.00% 0/21 • Day 0 to Day 120 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.	4.8% 1/21 • Day 0 to Day 120 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.	0.00% 0/24 • Day 0 to Day 120 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.
Vascular disorders Hot flush	0.00% 0/25 • Day 0 to Day 120 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.	0.00% 0/25 • Day 0 to Day 120 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.	0.00% 0/24 • Day 0 to Day 120 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.	0.00% 0/21 • Day 0 to Day 120 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.	0.00% 0/21 • Day 0 to Day 120 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.	8.3% 2/24 • Day 0 to Day 120 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.

Additional Information

Medical Director, Clinical Science

Takeda

Phone: +1-877-825-3327

Email: clinicaltrialregistry@tpna.com

Results disclosure agreements

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

Restriction type: OTHER