Comparison · NCT02114684-0efe0cee
Moxifloxacin vs Control: Proportion of Patients With Any Grade 3 or 4 Adverse Reactions in the Two Study Arms
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Moxifloxacin vs Control: Proportion of Patients With Any Grade 3 or 4 Adverse Reactions in the Two Study Arms. Trial comparisons, record NCT02114684-0efe0cee. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02114684-0efe0cee
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.439 | 0.345 | 0.537 | wilson | |
| Risk in group 2 | 0.255 | 0.179 | 0.35 | wilson | |
| Risk difference, group 1 minus group 2 | 0.184 | 0.0504 | 0.308 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.72 | 1.15 | 2.58 | log | |
| Odds ratio, group 1 over group 2 | 2.28 | 1.25 | 4.18 | log | |
| Number needed to treat, for one more participant with the outcome on Moxifloxacin than on Control | 5.44 | 3.24 | 19.8 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Moxifloxacin | A Moxifloxacin-containing oral regimen of Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), Moxifloxacin (M), substituting Moxifloxacin for Ethambutol.~The intervention arm substituted moxifloxacin for ethambutol (moxifloxacin group), and consisted of daily doses of moxifloxacin, rifampicin, isoniazid and pyrazinamide for 8 weeks, followed by daily doses of moxifloxacin, rifampicin and isoniazid for 16 weeks.~Participants in the moxifloxacin arm received daily 400 mg of moxifloxacin (Avelox®, Bayer Healthcare), weight-based rifampicin at 450 or 600 mg, and 225 or 300 mg of isoniazid, for participants 38-54 and ≥55 kg, respectively, during the 2-month intensive phase and 4-month continuation phase of TB treatment. During the intensive phase of treatment, pyrazinamide was used at 1500 and 2000mg in participants between 38-54 and ≥55 kg, respectively. | 43 | 98 | OG000 |
| Group 2 | Control | An Ethambutol oral regimen of Isoniazid (H), Rifampicin(R), Pyrazinamide (Z), Ethambutol(E), substituting Ethambutol for Moxifloxacin.~Daily doses of rifampicin, isoniazid, pyrazinamide and ethambutol for 8 weeks (intensive phase), followed by daily doses of rifampicin and isoniazid for 16 weeks (Continuation phase).~During the first two months (intensive phase) of treatment, participants in the control arm received the following weight-based doses by fixed dose combination tablets: Participants who were 38 - 54kg received rifampicin 450mg, isoniazid 225mg, pyrazinamide 1200mg, ethambutol 825mg; participants who were 54 - 70kg received rifampicin 600mg, isoniazid 300mg, pyrazinamide 1600mg, ethambutol 1100mg; participants who were \> 70 kg received rifampicin 750mg, isoniazid 375mg, pyrazinamide 2000mg, ethambutol 1375mg. During the subsequent four months (continuation phase), participants continued on the same weight-based doses of rifampicin and isoniazid. | 25 | 98 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Proportion of Patients With Any Grade 3 or 4 Adverse Reactions in the Two Study Arms
- Description
To compare the proportion of patients with any Grade 3 or 4 adverse reactions in the two study arms. Outcome measured in terms of number of participants with at least one grade 3 or 4 events, and not in number of events.
- Time frame
- Up to 2 years
- Population
Source ClinicalTrials.gov
Trial
- Title
- Improving Retreatment Success (IMPRESS)
- NCT number
- NCT02114684
- Phases
- PHASE1, PHASE2
- Conditions
- Recurrent Tuberculosis
- Interventions
- moxifloxacin
- Lead sponsor
- Centre for the AIDS Programme of Research in South Africa
- Results first posted
- 2019-08-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02114684?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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