Trial · NCT02175225
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 90 Days | 90 days | The primary outcome measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-2 at 90 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome. |
| Primary | Number of Subjects Experiencing Serious Adverse Events | 90 days | Number of subjects experiencing Serious adverse events at any time from randomization through day 90 |
| Primary | Number of Subjects With Serious Adverse Events Within 7 Days | 7 days | Number of Subjects Experiencing Serious Adverse Events within 7 days of randomization |
| Secondary | Proportion of Patients With mRS Score 0-3 at 90 Days | 90 days | Another measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-3 at 90 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome. Although mRS 0-3 is less favorable than the primary outcome of mRS 0-2, it would still be a desirable effect in patients with ICH given that no treatments exist to reduce disability. |
| Secondary | Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 180 Days | 180 days | Another measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-2 at 180 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome. |
| Secondary | Proportion of Patients With Modified Rankin Scale (mRS) Score 0-3 at 180 Days | 180 days | Another measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-3 at 180 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome. |
| Secondary | Proportion of Subjects With Good Outcome (mRS 0-2) in the Early vs. Delayed Treatment Time Windows | 90 days | Analyses will be expanded to include an interaction between treatment and OTT window and the magnitude of the treatment effect, and corresponding confidence interval, will be estimated for each time window (\<12 hours vs. \>/= 12 hours) in order to explore the presence of a differential treatment effect in the OTT windows. |
| Other | Ordinal Distribution of Scores on mRS at Day 90 | 90 days | The overall ordinal distribution of scores on mRS at 90 days in DFO- and placebo-treated subjects will be determined. |
| Other | Ordinal Distribution of Scores on mRS at 180 Days | 180 days | The overall ordinal distribution of scores on mRS at 180 days in DFO- and placebo-treated subjects will be determined. |
| Other | Adverse Event of Special Interest: Number of Patients With Allergic Reactions (During Infusion of Study Drug) | during the study infusion | Adverse event of special interest: anaphylaxis at any time during the study infusion |
| Other | Adverse Event of Special Interest: Number of Patients With Hypotension | during the study infusion | Hypotension requiring medical intervention at any time during the study infusion that could not be explained by other causes |
| Other | Adverse Event of Special Interest: Number of Patients With New Visual or Auditory Changes | after initiation of study infusion | Adverse event of special interest: development of new and unexplained visual or auditory changes after initiation of the study infusion |
| Other | Adverse Event of Special Interest: Number of Patients With Respiratory Compromise | 7 days | Adverse event of special interest: Respiratory compromise of any cause, including acute respiratory distress syndrome, in hospital until day 7 or discharge \[whichever was earlier\] |
| Other | Number of Patients With Symptomatic Cerebral Edema | 7 days | Edema accompanied by an unexplained increase of more than four points on the US National Institutes of Health Stroke Scale or a decrease of more than two points in Glasgow Coma Scale score during the first week after the intracerebral haemorrhage. |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02175225/registered