A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of TAK-079 in Healthy Participants
Sponsor
Takeda (Industry)
Overall Status
Completed
CT.gov ID
NCT02219256
Collaborator
(none)
74
2
3
20
37
1.8
Study Details
Study Description
Brief Summary
The purpose of this study is to characterize the pharmacokinetic and safety and tolerability profile of TAK-079 following a single intravenous (IV) infusion or subcutaneous (SC) administration at escalating dose levels in healthy participants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
The drug being tested in this study is TAK-079. TAK-079 is being tested to find a safe and well-tolerated dose and to assess how TAK-079 is processed by the body. This study will look at pharmacokinetics, side effects, and laboratory results in people who take TAK-079 and is designed as a randomized single dose-rising study.
Therefore, each subsequent cohort will not start until the previous cohort has completed and the results are reviewed. Each participant will receive TAK-079 or placebo once only as an IV infusion or by SC administration. The starting dose for IV will be 0.0003 mg/kg and SC dose of 0.01 or 0.03 mg/kg was determined based on the no-observed-adverse-effect-level (NOAEL) results from the 13-week good laboratory practice (GLP) monkey toxicology study. If this dose is well-tolerated, the next group will receive a higher dose, etc, until a maximal tolerated dose is reached with the highest dose not to exceed 1.0 mg/kg.
This single-center trial will be conducted in the United Kingdom. The overall time to participate in this study is up to 17 weeks. Participants will make 11 visits to the clinic, including one 10-day period of confinement in the clinic. All participants will be contacted by telephone 14 days after the last visit to the clinic for a follow-up assessment.
Study Design
Study Type:
Interventional
Actual Enrollment
:
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single Intravenous Infusion and Subcutaneous Administration of TAK-079 in Healthy Subjects
Study Start Date
:
Aug 1, 2014
Actual Primary Completion Date
:
Apr 1, 2016
Actual Study Completion Date
:
Apr 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1: TAK-079 0.0003 mg/kg TAK-079 0.0003 mg/kg, infusion, intravenously, once. |
Drug: TAK-079
TAK-079 solution
|
| Experimental: Cohort 2-9: TAK-079 TBD TAK-079, infusion, intravenously or subcutaneously, once. Dose to be determined from data collected in previous IV or SC Cohort(s) |
Drug: TAK-079
TAK-079 solution
|
| Placebo Comparator: Placebo to TAK-079 Placebo to TAK-079, infusion, intravenously or subcutaneously, once. |
Drug: Placebo to TAK-079
Placebo to TAK-079 solution
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) [First dose up to Day 94]
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE was assessed according to severity; mild (transient and easily tolerated by the participant), moderate (causes the participant discomfort and interrupts the participant's usual activities) and severe (causes considerable interference with the participant's usual activities).
- Number of Participants Who Meet the Takeda Development Centre (TDC) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose [First dose up to Day 78]
- Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose [First dose up to Day 78]
- Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose [First dose up to Day 78]
Secondary Outcome Measures
- Cmax: Maximum Observed Serum Concentration for TAK-079 [Day 1 pre-dose and at multiple time-points (up to Day 78) post-dose]
- AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-079 [Day 1 pre-dose and at multiple time points (up to Day 78) post-dose]
- AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-079 [Day 1 pre-dose and at multiple time-points (up to Day 78) post-dose]
- Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab) [Baseline up to Day 78]
Results for ADA analysis were reported.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Is a healthy male or female with no child bearing potential who is 18 to 55 years of age inclusive.
-
The subject weighs at least 70 kilogram (kg) for cohort 1 and subsequent cohorts 50 kg (110.2 lb) and less than 100 kg (220.5 lb) and has a body mass index (BMI) range of 18.5 to 30 kilogram per square meter (kg/m^2), inclusive at Screening Visit 1.
-
A male participant who is non-sterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 6 months after last dose of study medication.
Exclusion Criteria:
-
Has received any investigational compound within the last 3 months or 5*T1/2 of the investigational compound,whichever is longer, prior to the day of study medication (Day 1).
-
Has received any live vaccinations, within the last 3 months prior to Screening or is expected to receive any vaccinations during the study or for 1 month after the Day 78 Study Exit visit.
-
Has received any other biologic medical products at any time in the past.
-
Has a positive drug or alcohol screening result, or a history of drug or alcohol abuse.
-
Has a positive test result for hepatitis or human immunodeficiency virus antibody.
-
Has any signs of an acute infection or history of frequent or chronic infection, or herpes zoster.
-
Has active or latent tuberculosis (TB)
-
Considered unfit for the study by the Principal Investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Headington | Oxford | United Kingdom | ||
| 2 | London | United Kingdom |
Sponsors and Collaborators
- Takeda
Investigators
- Study Director: Medical Director Clinical Science, Takeda
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Takeda
ClinicalTrials.gov Identifier:
NCT02219256
Other Study ID Numbers:
- TAK-079_101
- U1111-1155-5857
- 2013-004210-18
- 14/LO/1070
First Posted:
Aug 18, 2014
Last Update Posted:
May 3, 2017
Last Verified:
Mar 1, 2017
Study Results
Participant Flow
| Recruitment Details | Participants took part in the study at 1 investigative site in the United Kingdom (UK) from 01 August 2014 to 29 April 2016. |
|---|---|
| Pre-assignment Detail | Healthy participants were enrolled in 1 of 12 treatment groups to receive: TAK-079 placebo, 0.0003, 0.001, 0.003, 0.01, 0.03, 0.06 milligram per kilogram (mg/kg) Intravenously (IV) and TAK-079 placebo, 0.03, 0.1, 0.3, 0.6 mg/kg subcutaneously (SC). |
| Arm/Group Title | TAK-079 Pooled Placebo IV | TAK-079 0.0003 mg/kg IV | TAK-079 0.001 mg/kg IV | TAK-079 0.003 mg/kg IV | TAK-079 0.01 mg/kg IV | TAK-079 0.03 mg/kg IV | TAK-079 0.06 mg/kg IV | TAK-079 Pooled Placebo SC | TAK-079 0.03 mg/kg SC | TAK-079 0.1 mg/kg SC | TAK-079 0.3 mg/kg SC | TAK-079 0.6 mg/kg SC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | TAK-079 placebo-matching, infusion solution, IV, once on Day 1. | TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 placebo-matching, infusion solution, SC, once on Day 1. | TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1. | TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1 | TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1. | TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1. |
| Period Title: Overall Study | ||||||||||||
| STARTED | 12 | 4 | 4 | 4 | 6 | 6 | 6 | 8 | 6 | 6 | 6 | 6 |
| COMPLETED | 12 | 4 | 4 | 4 | 6 | 6 | 6 | 8 | 6 | 6 | 6 | 6 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | TAK-079 Pooled Placebo IV | TAK-079 0.0003 mg/kg IV | TAK-079 0.001 mg/kg IV | TAK-079 0.003 mg/kg IV | TAK-079 0.01 mg/kg IV | TAK-079 0.03 mg/kg IV | TAK-079 0.06 mg/kg IV | TAK-079 Pooled Placebo SC | TAK-079 0.03 mg/kg SC | TAK-079 0.1 mg/kg SC | TAK-079 0.3 mg/kg SC | TAK-079 0.6 mg/kg SC | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | TAK-079 placebo-matching, infusion solution, IV, once on Day 1. | TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 placebo-matching, infusion solution, SC, once on Day 1. | TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1. | TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1 | TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1. | TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1. | Total of all reporting groups |
| Overall Participants | 12 | 4 | 4 | 4 | 6 | 6 | 6 | 8 | 6 | 6 | 6 | 6 | 74 |
| Age (years) [Mean (Standard Deviation) ] | |||||||||||||
| Mean (Standard Deviation) [years] |
35.5
(10.61)
|
23.5
(3.42)
|
42.3
(12.12)
|
32.8
(10.72)
|
36.2
(9.52)
|
32.3
(5.92)
|
35.7
(11.60)
|
34.9
(13.61)
|
36.7
(10.33)
|
31.0
(8.15)
|
40.8
(7.83)
|
27.7
(8.16)
|
34.3
(10.19)
|
| Sex: Female, Male (Count of Participants) | |||||||||||||
| Female |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
12.5%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
1.4%
|
| Male |
12
100%
|
4
100%
|
4
100%
|
4
100%
|
6
100%
|
6
100%
|
6
100%
|
7
87.5%
|
6
100%
|
6
100%
|
6
100%
|
6
100%
|
73
98.6%
|
| Race/Ethnicity, Customized (participants) [Number] | |||||||||||||
| White |
8
66.7%
|
3
75%
|
2
50%
|
3
75%
|
4
66.7%
|
5
83.3%
|
5
83.3%
|
6
75%
|
4
66.7%
|
3
50%
|
6
100%
|
2
33.3%
|
51
68.9%
|
| Black or African American |
1
8.3%
|
0
0%
|
0
0%
|
1
25%
|
0
0%
|
0
0%
|
0
0%
|
1
12.5%
|
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
4
5.4%
|
| Asian |
2
16.7%
|
0
0%
|
1
25%
|
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
1
12.5%
|
2
33.3%
|
3
50%
|
0
0%
|
3
50%
|
13
17.6%
|
| Multiracial |
1
8.3%
|
1
25%
|
1
25%
|
0
0%
|
2
33.3%
|
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
6
8.1%
|
| Region of Enrollment (participants) [Number] | |||||||||||||
| United Kingdom |
12
100%
|
4
100%
|
4
100%
|
4
100%
|
6
100%
|
6
100%
|
6
100%
|
8
100%
|
6
100%
|
6
100%
|
6
100%
|
6
100%
|
74
100%
|
| Smoking Classification (participants) [Number] | |||||||||||||
| Currently smoking |
4
33.3%
|
0
0%
|
1
25%
|
0
0%
|
1
16.7%
|
3
50%
|
0
0%
|
0
0%
|
1
16.7%
|
1
16.7%
|
1
16.7%
|
1
16.7%
|
13
17.6%
|
| Never smoked |
6
50%
|
2
50%
|
2
50%
|
3
75%
|
3
50%
|
2
33.3%
|
4
66.7%
|
7
87.5%
|
3
50%
|
4
66.7%
|
4
66.7%
|
4
66.7%
|
44
59.5%
|
| Ex-smoker |
2
16.7%
|
2
50%
|
1
25%
|
1
25%
|
2
33.3%
|
1
16.7%
|
2
33.3%
|
1
12.5%
|
2
33.3%
|
1
16.7%
|
1
16.7%
|
1
16.7%
|
17
23%
|
| Caffeine Classification (participants) [Number] | |||||||||||||
| Had caffeine consumption |
9
75%
|
3
75%
|
3
75%
|
1
25%
|
6
100%
|
6
100%
|
3
50%
|
3
37.5%
|
3
50%
|
6
100%
|
5
83.3%
|
2
33.3%
|
50
67.6%
|
| Had no caffeine consumption |
3
25%
|
1
25%
|
1
25%
|
3
75%
|
0
0%
|
0
0%
|
3
50%
|
5
62.5%
|
3
50%
|
0
0%
|
1
16.7%
|
4
66.7%
|
24
32.4%
|
| Alcohol Classification (participants) [Number] | |||||||||||||
| Drinks everyday |
5
41.7%
|
1
25%
|
2
50%
|
1
25%
|
3
50%
|
1
16.7%
|
4
66.7%
|
2
25%
|
4
66.7%
|
1
16.7%
|
2
33.3%
|
4
66.7%
|
30
40.5%
|
| Never drank |
7
58.3%
|
3
75%
|
2
50%
|
3
75%
|
3
50%
|
5
83.3%
|
2
33.3%
|
6
75%
|
2
33.3%
|
5
83.3%
|
4
66.7%
|
2
33.3%
|
44
59.5%
|
| Height (centimeter (cm)) [Mean (Standard Deviation) ] | |||||||||||||
| Mean (Standard Deviation) [centimeter (cm)] |
174.7
(9.17)
|
181.3
(6.90)
|
175.0
(8.04)
|
179.5
(10.91)
|
173.8
(1.47)
|
175.5
(7.97)
|
173.8
(7.03)
|
177.8
(7.91)
|
176.8
(3.31)
|
181.2
(8.80)
|
177.8
(6.68)
|
172.3
(4.32)
|
176.3
(7.32)
|
| Weight (kilogram (kg)) [Mean (Standard Deviation) ] | |||||||||||||
| Mean (Standard Deviation) [kilogram (kg)] |
73.98
(7.355)
|
80.63
(8.768)
|
76.68
(9.011)
|
72.10
(9.090)
|
75.45
(11.042)
|
69.12
(8.043)
|
71.32
(6.187)
|
78.53
(12.508)
|
79.77
(8.584)
|
75.18
(9.887)
|
79.73
(8.311)
|
71.25
(9.434)
|
75.20
(9.149)
|
| Body Mass Index (BMI) (kilogram per square meter (kg/m^2)) [Mean (Standard Deviation) ] | |||||||||||||
| Mean (Standard Deviation) [kilogram per square meter (kg/m^2)] |
24.32
(2.507)
|
24.53
(2.337)
|
25.05
(2.456)
|
22.33
(1.176)
|
24.93
(3.420)
|
22.45
(2.118)
|
23.60
(1.383)
|
24.80
(3.311)
|
25.52
(2.763)
|
22.85
(1.947)
|
25.22
(2.225)
|
23.98
(3.064)
|
24.18
(2.553)
|
Outcome Measures
| Title | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) |
|---|---|
| Description | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE was assessed according to severity; mild (transient and easily tolerated by the participant), moderate (causes the participant discomfort and interrupts the participant's usual activities) and severe (causes considerable interference with the participant's usual activities). |
| Time Frame | First dose up to Day 94 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits. |
| Arm/Group Title | TAK-079 Pooled Placebo IV | TAK-079 0.0003 mg/kg IV | TAK-079 0.001 mg/kg IV | TAK-079 0.003 mg/kg IV | TAK-079 0.01 mg/kg IV | TAK-079 0.03 mg/kg IV | TAK-079 0.06 mg/kg IV | TAK-079 Pooled Placebo SC | TAK-079 0.03 mg/kg SC | TAK-079 0.1 mg/kg SC | TAK-079 0.3 mg/kg SC | TAK-079 0.6 mg/kg SC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | TAK-079 placebo-matching, infusion solution, IV, once on Day 1. | TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 placebo-matching, infusion solution, SC, once on Day 1. | TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1. | TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1 | TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1. | TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1. |
| Measure Participants | 12 | 4 | 4 | 4 | 6 | 6 | 6 | 8 | 6 | 6 | 6 | 6 |
| TEAE: Mild |
6
50%
|
3
75%
|
2
50%
|
1
25%
|
5
83.3%
|
4
66.7%
|
2
33.3%
|
3
37.5%
|
5
83.3%
|
4
66.7%
|
4
66.7%
|
4
66.7%
|
| TEAE: Moderate |
5
41.7%
|
0
0%
|
1
25%
|
2
50%
|
1
16.7%
|
2
33.3%
|
4
66.7%
|
3
37.5%
|
1
16.7%
|
2
33.3%
|
1
16.7%
|
1
16.7%
|
| TEAE: Severe |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| SAE |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants Who Meet the Takeda Development Centre (TDC) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose |
|---|---|
| Description | |
| Time Frame | First dose up to Day 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits. |
| Arm/Group Title | TAK-079 Pooled Placebo IV | TAK-079 0.0003 mg/kg IV | TAK-079 0.001 mg/kg IV | TAK-079 0.003 mg/kg IV | TAK-079 0.01 mg/kg IV | TAK-079 0.03 mg/kg IV | TAK-079 0.06 mg/kg IV | TAK-079 Pooled Placebo SC | TAK-079 0.03 mg/kg SC | TAK-079 0.1 mg/kg SC | TAK-079 0.3 mg/kg SC | TAK-079 0.6 mg/kg SC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | TAK-079 placebo-matching, infusion solution, IV, once on Day 1. | TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 placebo-matching, infusion solution, SC, once on Day 1. | TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1. | TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1 | TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1. | TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1. |
| Measure Participants | 12 | 4 | 4 | 4 | 6 | 6 | 6 | 8 | 6 | 6 | 6 | 6 |
| Number [participants] |
1
8.3%
|
1
25%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
25%
|
0
0%
|
0
0%
|
0
0%
|
2
33.3%
|
| Title | Cmax: Maximum Observed Serum Concentration for TAK-079 |
|---|---|
| Description | |
| Time Frame | Day 1 pre-dose and at multiple time-points (up to Day 78) post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The pharmacokinetic(PK) analysis set included all participants who received study drug and had at least 1 measurable serum concentration of TAK-079. PK analysis was performed for TAK-079 0.03, 0.06 mg/kg IV and 0.6 SC mg/kg dose groups only, since serum concentrations of TAK-079 were below the LLOQ at all PK sampling time-points for remaining arms. |
| Arm/Group Title | TAK-079 Pooled Placebo IV | TAK-079 0.0003 mg/kg IV | TAK-079 0.001 mg/kg IV | TAK-079 0.003 mg/kg IV | TAK-079 0.01 mg/kg IV | TAK-079 0.03 mg/kg IV | TAK-079 0.06 mg/kg IV | TAK-079 Pooled Placebo SC | TAK-079 0.03 mg/kg SC | TAK-079 0.1 mg/kg SC | TAK-079 0.3 mg/kg SC | TAK-079 0.6 mg/kg SC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | TAK-079 placebo-matching, infusion solution, IV, once on Day 1. | TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 placebo-matching, infusion solution, SC, once on Day 1. | TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1. | TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1 | TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1. | TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 6 | 6 | 0 | 0 | 0 | 0 | 5 |
| Mean (Standard Deviation) [nanogram per milliliter (ng/mL)] |
21.4
(8.3)
|
100.4
(51.7)
|
23.0
(15.5)
|
| Title | AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-079 |
|---|---|
| Description | |
| Time Frame | Day 1 pre-dose and at multiple time points (up to Day 78) post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PK analysis set:all participants who received study drug and had at least 1 measurable serum concentration of TAK-079.A valid AUClast was derived for TAK-079 0.6 mg/kgSC dose group only, since serum concentrations of TAK-079 were either below the LLOQ at all PK sampling time-points or too limited to estimate AUClast reliably for remaining arms. |
| Arm/Group Title | TAK-079 Pooled Placebo IV | TAK-079 0.0003 mg/kg IV | TAK-079 0.001 mg/kg IV | TAK-079 0.003 mg/kg IV | TAK-079 0.01 mg/kg IV | TAK-079 0.03 mg/kg IV | TAK-079 0.06 mg/kg IV | TAK-079 Pooled Placebo SC | TAK-079 0.03 mg/kg SC | TAK-079 0.1 mg/kg SC | TAK-079 0.3 mg/kg SC | TAK-079 0.6 mg/kg SC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | TAK-079 placebo-matching, infusion solution, IV, once on Day 1. | TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 placebo-matching, infusion solution, SC, once on Day 1. | TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1. | TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1 | TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1. | TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 |
| Mean (Standard Deviation) [nanogram*day per milliliter (ng*day/mL)] |
90.4
(83.2)
|
| Title | AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-079 |
|---|---|
| Description | |
| Time Frame | Day 1 pre-dose and at multiple time-points (up to Day 78) post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PK analysis set included all participants who received study drug and had at least 1 measurable serum concentration of TAK-079. PK analysis was performed for TAK-079 0.6 mg/kg SC dose groups only, since serum concentrations of TAK-079 were below the LLOQ at all PK sampling time-points for remaining arms. |
| Arm/Group Title | TAK-079 Pooled Placebo IV | TAK-079 0.0003 mg/kg IV | TAK-079 0.001 mg/kg IV | TAK-079 0.003 mg/kg IV | TAK-079 0.01 mg/kg IV | TAK-079 0.03 mg/kg IV | TAK-079 0.06 mg/kg IV | TAK-079 Pooled Placebo SC | TAK-079 0.03 mg/kg SC | TAK-079 0.1 mg/kg SC | TAK-079 0.3 mg/kg SC | TAK-079 0.6 mg/kg SC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | TAK-079 placebo-matching, infusion solution, IV, once on Day 1. | TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 placebo-matching, infusion solution, SC, once on Day 1. | TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1. | TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1 | TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1. | TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
| Mean (Standard Deviation) [ng*day/mL] |
212
(103)
|
| Title | Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab) |
|---|---|
| Description | Results for ADA analysis were reported. |
| Time Frame | Baseline up to Day 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits. Due to change in planned analysis testing of NAb activity of ADA positive samples was not analysed. |
| Arm/Group Title | TAK-079 Pooled Placebo IV | TAK-079 0.0003 mg/kg IV | TAK-079 0.001 mg/kg IV | TAK-079 0.003 mg/kg IV | TAK-079 0.01 mg/kg IV | TAK-079 0.03 mg/kg IV | TAK-079 0.06 mg/kg IV | TAK-079 Pooled Placebo SC | TAK-079 0.03 mg/kg SC | TAK-079 0.1 mg/kg SC | TAK-079 0.3 mg/kg SC | TAK-079 0.6 mg/kg SC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | TAK-079 placebo-matching, infusion solution, IV, once on Day 1. | TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 placebo-matching, infusion solution, SC, once on Day 1. | TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1. | TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1 | TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1. | TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1. |
| Measure Participants | 12 | 4 | 4 | 4 | 6 | 6 | 6 | 8 | 6 | 6 | 6 | 6 |
| Number [percentage of participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
16.7
278.3%
|
0
0%
|
33.3
555%
|
16.7
278.3%
|
0
0%
|
16.7
(102.58826)
278.3%
|
| Title | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose |
|---|---|
| Description | |
| Time Frame | First dose up to Day 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits. |
| Arm/Group Title | TAK-079 Pooled Placebo IV | TAK-079 0.0003 mg/kg IV | TAK-079 0.001 mg/kg IV | TAK-079 0.003 mg/kg IV | TAK-079 0.01 mg/kg IV | TAK-079 0.03 mg/kg IV | TAK-079 0.06 mg/kg IV | TAK-079 Pooled Placebo SC | TAK-079 0.03 mg/kg SC | TAK-079 0.1 mg/kg SC | TAK-079 0.3 mg/kg SC | TAK-079 0.6 mg/kg SC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | TAK-079 placebo-matching, infusion solution, IV, once on Day 1. | TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 placebo-matching, infusion solution, SC, once on Day 1. | TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1. | TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1 | TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1. | TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1. |
| Measure Participants | 12 | 4 | 4 | 4 | 6 | 6 | 6 | 8 | 6 | 6 | 6 | 6 |
| Number [participants] |
6
50%
|
2
50%
|
2
50%
|
2
50%
|
1
16.7%
|
4
66.7%
|
6
100%
|
4
50%
|
4
66.7%
|
4
66.7%
|
3
50%
|
1
16.7%
|
| Title | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose |
|---|---|
| Description | |
| Time Frame | First dose up to Day 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits. |
| Arm/Group Title | TAK-079 Pooled Placebo IV | TAK-079 0.0003 mg/kg IV | TAK-079 0.001 mg/kg IV | TAK-079 0.003 mg/kg IV | TAK-079 0.01 mg/kg IV | TAK-079 0.03 mg/kg IV | TAK-079 0.06 mg/kg IV | TAK-079 Pooled Placebo SC | TAK-079 0.03 mg/kg SC | TAK-079 0.1 mg/kg SC | TAK-079 0.3 mg/kg SC | TAK-079 0.6 mg/kg SC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | TAK-079 placebo-matching, infusion solution, IV, once on Day 1. | TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 placebo-matching, infusion solution, SC, once on Day 1. | TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1. | TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1 | TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1. | TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1. |
| Measure Participants | 12 | 4 | 4 | 4 | 6 | 6 | 6 | 8 | 6 | 6 | 6 | 6 |
| Number [participants] |
8
66.7%
|
3
75%
|
3
75%
|
1
25%
|
3
50%
|
5
83.3%
|
1
16.7%
|
5
62.5%
|
4
66.7%
|
5
83.3%
|
1
16.7%
|
0
0%
|
Adverse Events
| Time Frame | Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 94 days after the last dose of double-blind study drug. | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||||||||||||||||||||||
| Arm/Group Title | TAK-079 Pooled Placebo IV | TAK-079 0.0003 mg/kg IV | TAK-079 0.001 mg/kg IV | TAK-079 0.003 mg/kg IV | TAK-079 0.01 mg/kg IV | TAK-079 0.03 mg/kg IV | TAK-079 0.06 mg/kg IV | TAK-079 Pooled Placebo SC | TAK-079 0.03 mg/kg SC | TAK-079 0.1 mg/kg SC | TAK-079 0.3 mg/kg SC | TAK-079 0.6 mg/kg SC | ||||||||||||
| Arm/Group Description | TAK-079 placebo-matching, infusion solution, IV, once on Day 1. | TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1. | TAK-079 placebo-matching, infusion solution, SC, once on Day 1. | TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1. | TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1 | TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1. | TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1. | ||||||||||||
All Cause Mortality |
||||||||||||||||||||||||
| TAK-079 Pooled Placebo IV | TAK-079 0.0003 mg/kg IV | TAK-079 0.001 mg/kg IV | TAK-079 0.003 mg/kg IV | TAK-079 0.01 mg/kg IV | TAK-079 0.03 mg/kg IV | TAK-079 0.06 mg/kg IV | TAK-079 Pooled Placebo SC | TAK-079 0.03 mg/kg SC | TAK-079 0.1 mg/kg SC | TAK-079 0.3 mg/kg SC | TAK-079 0.6 mg/kg SC | |||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||||||||
Serious Adverse Events |
||||||||||||||||||||||||
| TAK-079 Pooled Placebo IV | TAK-079 0.0003 mg/kg IV | TAK-079 0.001 mg/kg IV | TAK-079 0.003 mg/kg IV | TAK-079 0.01 mg/kg IV | TAK-079 0.03 mg/kg IV | TAK-079 0.06 mg/kg IV | TAK-079 Pooled Placebo SC | TAK-079 0.03 mg/kg SC | TAK-079 0.1 mg/kg SC | TAK-079 0.3 mg/kg SC | TAK-079 0.6 mg/kg SC | |||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||||||
| TAK-079 Pooled Placebo IV | TAK-079 0.0003 mg/kg IV | TAK-079 0.001 mg/kg IV | TAK-079 0.003 mg/kg IV | TAK-079 0.01 mg/kg IV | TAK-079 0.03 mg/kg IV | TAK-079 0.06 mg/kg IV | TAK-079 Pooled Placebo SC | TAK-079 0.03 mg/kg SC | TAK-079 0.1 mg/kg SC | TAK-079 0.3 mg/kg SC | TAK-079 0.6 mg/kg SC | |||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 11/12 (91.7%) | 3/4 (75%) | 3/4 (75%) | 3/4 (75%) | 6/6 (100%) | 6/6 (100%) | 6/6 (100%) | 6/8 (75%) | 6/6 (100%) | 6/6 (100%) | 5/6 (83.3%) | 5/6 (83.3%) | ||||||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||||||||
| Lymphadenopathy | 1/12 (8.3%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Cardiac disorders | ||||||||||||||||||||||||
| Palpitations | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | ||||||||||||
| Ear and labyrinth disorders | ||||||||||||||||||||||||
| Ear pain | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Tinnitus | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/8 (12.5%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Eye disorders | ||||||||||||||||||||||||
| Eye irritation | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||||||
| Diarrhoea | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 1/6 (16.7%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | ||||||||||||
| Vomiting | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | ||||||||||||
| Abdominal pain | 0/12 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Dyspepsia | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Faeces soft | 0/12 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Food poisoning | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Gingival bleeding | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Haematemesis | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Hypoaesthesia oral | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Nausea | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | ||||||||||||
| Odynophagia | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Toothache | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Abdominal pain upper | 1/12 (8.3%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Salivary hypersecretion | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Constipation | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/8 (12.5%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Abdominal discomfort | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| General disorders | ||||||||||||||||||||||||
| Pyrexia | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 3/6 (50%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | ||||||||||||
| Asthenia | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/6 (16.7%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Catheter site bruise | 1/12 (8.3%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Chills | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 2/6 (33.3%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | ||||||||||||
| Fatigue | 1/12 (8.3%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/8 (12.5%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Feeling cold | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | ||||||||||||
| Feeling hot | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 2/6 (33.3%) | ||||||||||||
| Malaise | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Vessel puncture site bruise | 1/12 (8.3%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Catheter site phlebitis | 1/12 (8.3%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Catheter site related reaction | 1/12 (8.3%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Instillation site bruise | 1/12 (8.3%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Injection site erythema | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/8 (12.5%) | 5/6 (83.3%) | 0/6 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | ||||||||||||
| Injection site pain | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 3/6 (50%) | 3/6 (50%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Influenza like illness | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 1/6 (16.7%) | ||||||||||||
| Discomfort | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | ||||||||||||
| Injection site swelling | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Infections and infestations | ||||||||||||||||||||||||
| Nasopharyngitis | 2/12 (16.7%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 2/6 (33.3%) | 1/8 (12.5%) | 2/6 (33.3%) | 3/6 (50%) | 1/6 (16.7%) | 3/6 (50%) | ||||||||||||
| Oral herpes | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Onychomycosis | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Respiratory tract infection | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Epididymitis | 1/12 (8.3%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||||||||
| Arthropod bite | 1/12 (8.3%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Contusion | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/8 (12.5%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | ||||||||||||
| Joint injury | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Rib fracture | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Thermal burn | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Ligament sprain | 1/12 (8.3%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Limb injury | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/8 (12.5%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||||||
| Arthralgia | 0/12 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/8 (12.5%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Back pain | 1/12 (8.3%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Muscle spasms | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Muscle tightness | 0/12 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Musculoskeletal chest pain | 0/12 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Limb discomfort | 1/12 (8.3%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | ||||||||||||
| Musculoskeletal pain | 1/12 (8.3%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Pain in extremity | 1/12 (8.3%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Myalgia | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | ||||||||||||
| Nervous system disorders | ||||||||||||||||||||||||
| Headache | 4/12 (33.3%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 2/6 (33.3%) | 3/6 (50%) | 5/6 (83.3%) | 2/8 (25%) | 2/6 (33.3%) | 1/6 (16.7%) | 1/6 (16.7%) | 3/6 (50%) | ||||||||||||
| Dizziness postural | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 5/6 (83.3%) | 1/8 (12.5%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/6 (16.7%) | ||||||||||||
| Somnolence | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 2/6 (33.3%) | 0/8 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Dizziness | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Dysgeusia | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Migraine | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Paraesthesia | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | ||||||||||||
| Syncope | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/8 (12.5%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Psychiatric disorders | ||||||||||||||||||||||||
| Abnormal dreams | 0/12 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Initial insomnia | 0/12 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Restlessness | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Renal and urinary disorders | ||||||||||||||||||||||||
| Oliguria | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||||
| Oropharyngeal pain | 1/12 (8.3%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 1/8 (12.5%) | 0/6 (0%) | 2/6 (33.3%) | 0/6 (0%) | 1/6 (16.7%) | ||||||||||||
| Nasal congestion | 0/12 (0%) | 1/4 (25%) | 1/4 (25%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/6 (16.7%) | ||||||||||||
| Dyspnoea | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Cough | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | ||||||||||||
| Epistaxis | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | ||||||||||||
| Rhinorrhoea | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/8 (12.5%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | ||||||||||||
| Tonsillar inflammation | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Productive cough | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/8 (12.5%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||||||
| Hyperhidrosis | 1/12 (8.3%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Dermatitis | 1/12 (8.3%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Rash maculo-papular | 1/12 (8.3%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Dermatitis contact | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Rash macular | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
| Erythema | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/8 (12.5%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Medical Director |
|---|---|
| Organization | Takeda |
| Phone | +1-877-825-3327 |
| trialdisclosures@takeda.com |
Responsible Party:
Takeda
ClinicalTrials.gov Identifier:
NCT02219256
Other Study ID Numbers:
- TAK-079_101
- U1111-1155-5857
- 2013-004210-18
- 14/LO/1070
First Posted:
Aug 18, 2014
Last Update Posted:
May 3, 2017
Last Verified:
Mar 1, 2017