Trial · NCT04654351
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAE) | Up to approximately 6 months | Safety analysis set included all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Injection Site Reactions | Postdose, up to Day 8 | Safety analysis set included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants Who Experienced at Least One TEAE Related to Resting 12-lead Electrocardiogram | Up to approximately 6 months | Safety analysis set included all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced at Least One TEAE Related to Vital Sign | Up to approximately 6 months | Safety analysis set included all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced at Least One TEAE Related to Clinical Laboratory Parameters | Up to approximately 6 months | Safety analysis set included all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experience at Least One TEAE Related to Clinically Significant Changes in Reproductive Hormones | Up to approximately 6 months | Safety analysis set included all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Reported Presence of Anti-icatibant Antibodies | Up to approximately 6 months | Safety analysis set was defined as all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Onset of Symptom Relief With Investigator-Rated Symptom Scores Assessed by Investigator | Baseline, and post dose on Day 1 | Full analysis set included all participants who received at least 1 dose of study drug. | hours | MEDIAN |
| SECONDARY | Time to Onset of Symptom Relief With Faces Pain Scale-Revised (FPS-R) Scores for Participants of 4 Years Age and Older | Baseline, and post dose on Day 1 | Full analysis set included all participants who received at least 1 dose of study drug. | hours | MEDIAN |
| SECONDARY | Time to Onset of Symptom Relief by Faces, Legs, Activity, Cry, and Consolability (FLACC) Scale Assessed by Investigator for Participants of Younger Than 4 Years Age | Baseline, and post dose on Day 1 | As there were no participants between 2 to \<4 years of age enrolled in this study, data was not collected for this outcome measure. | ||
| SECONDARY | Number of Participants Who Were Treated With Rescue Medication During Study | Up to approximately 6 months | Safety analysis set was defined as all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Worsened Intensity of Clinical HAE Symptoms Between 2 and 4 Hours After Treatment With SC Icatibant Using Investigator-Rated Symptom Scores | From 2 hours post-dose to 4 hours post-dose | Full analysis set was defined as all participants who had received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Initial Symptom Improvement Reported by Investigator | Up to 8 hours post dose (or till the onset of HAE attacks were resolved) | Full analysis set was defined as all participants who had received at least 1 dose of study drug. | hours | MEDIAN |
| SECONDARY | Time to Initial Symptom Improvement Reported by Participant | Up to 8 hours post dose (or till the onset of HAE attacks were resolved) | Full analysis set was defined as all participants who had received at least 1 dose of study drug. | hours | MEDIAN |
| SECONDARY | Plasma Concentration for TAK-667 | Day 1 pre-dose and at multiple timepoints post-dose | Safety analysis set was defined as all participants who received at least 1 dose of study drug. | ug/l | MEDIAN |
| SECONDARY | Plasma Concentration for TAK-667 Metabolite M-I | Day 1 pre-dose and at multiple timepoints post-dose | Safety analysis set was defined as all participants who received at least 1 dose of study drug. | ug/l | MEDIAN |
| SECONDARY | Plasma Concentration for TAK-667 Metabolite M-II | Day 1 pre-dose and at multiple timepoints post-dose | Safety analysis set was defined as all participants who received at least 1 dose of study drug. | ug/l | MEDIAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04654351/outcomes