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Comparison · NCT05842941-e01dde8c

DNL343 vs Matching Placebo: Number of Participants With Death or Permanent Assisted Ventilation (PAV)

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. DNL343 vs Matching Placebo: Number of Participants With Death or Permanent Assisted Ventilation (PAV). Trial comparisons, record NCT05842941-e01dde8c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05842941-e01dde8c

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.0430.0220.0826wilson
Risk in group 20.0360.01550.0814wilson
Risk difference, group 1 minus group 20.00704-0.04310.0516newcombe hybrid score
Risk ratio, group 1 over group 21.20.43.58log
Odds ratio, group 1 over group 21.20.3853.76log
Number needed to treat, for one more participant with the outcome on DNL343 than on Matching Placebo142from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1DNL343DNL343 is administered orally once a day for 24 weeks.8186OG000
Group 2Matching PlaceboMatching Placebo is administered orally once a day for 24 weeks.5139OG001

Outcome

Type
SECONDARY
Title
Number of Participants With Death or Permanent Assisted Ventilation (PAV)
Description
The number of participants who died or met the criterion for a death equivalent from the date of their baseline visit to the end of the Week 24 visit window (generally 175 days after baseline). The death equivalent criterion is use of permanent assisted ventilation (PAV) for more than 22 hours per day for more than 7 days in a row.
Time frame
Baseline to 24 weeks
Population
Outcome measure data was analyzed using the Efficacy Concurrent-controls Set (ECC), which included concurrent shared placebos from other regimens if randomized within 180 days of the first and last randomization for the applicable regimen, excluding any shared placebos also include in the focal regimen, as pre-specified in the Regimen Statistical Analysis Plan. Regimen F (NCT#05740813) and Regimen G (NCT#05842941) contributed placebo participants into the shared placebo cohort used for analysis.

Source ClinicalTrials.gov

Trial

Title
HEALEY ALS Platform Trial - Regimen G DNL343
NCT number
NCT05842941
Phases
PHASE2, PHASE3
Conditions
Amyotrophic Lateral Sclerosis
Interventions
DNL343, Matching Placebo
Lead sponsor
Merit E. Cudkowicz, MD
Results first posted
2026-01-28

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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