Trial · NCT04187144
Outcomes35
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 35
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S (IA Set) | TOC visit (Days 9 to 16) | Microbiological intent-to-treat susceptible to nitrofurantoin - (Micro-ITT NTF-S) (Interim Analysis \[IA\] Set) population included participants in the micro ITT NTF-S who per the interim analysis data had the opportunity to reach their Test of Cure (TOC) visit, or had not yet reached their TOC visit, but were already known to be failures. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S Population | TOC visit (Days 9 to 16) | Micro-ITT NTF-S population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | TOC visit (Days 9 to 16) | Micro-ITT NTF-S population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population | TOC visit (Days 9 to 16) | Micro-ITT NTF-S population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Microbiological Outcome (MO) at the TOC Visit - Micro-ITT NTF-S Population | TOC Visit (Days 9 to 16) | Micro-ITT NTF-S population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Microbiological Response at the TOC Visit - Micro-ITT NTF-S Population | TOC visit (Days 9 to 16) | Micro-ITT NTF-S population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | FU visit (Days 21 to 31) | Micro-ITT NTF-S population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population | FU visit (Days 21 to 31) | Micro-ITT NTF-S population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population | FU visit (Days 21 to 31) | Micro-ITT NTF-S population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | FU visit (Days 21 to 31) | Micro-ITT NTF-S population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Microbiological Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population | FU visit (Days 21 to 31) | Micro-ITT NTF-S population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population | TOC visit (Days 9 to 16) | Intent-to-Treat (ITT) population included all participants randomly assigned to study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response at the TOC Visit - Intent-to-Treat (ITT) Population | TOC visit (Days 9 to 16) | Intent-to-Treat (ITT) population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | FU visit (Days 21 to 31) | Intent-to-Treat (ITT) population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | FU visit (Days 21 to 31) | Intent-to-Treat (ITT) population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From the time of first dose (Day 1) through the final follow-up visit (Day 21-31) | Safety population included all randomized participants who receive at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious Adverse Events (SAEs) | From the time of first dose (Day 1) through the final follow-up visit (Day 21-31) | Safety population included all randomized participants who receive at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16) | Safety population. Only those participants with data available at the specified data points were analyzed. | Giga cells per Liter (10^9 cells/L) | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameter: Hemoglobin Level | Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16) | Safety population. Only those participants with data available at the specified data points were analyzed. | Gram per Liter (g/L) | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameter: Hematocrit Level | Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16) | Safety population. Only those participants with data available at the specified data points were analyzed. | Percentage of hematocrit | MEAN |
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/NCT04187144/outcomes