Comparison · NCT03444870-52c2b985
Global - OLE Period: Gantenerumab (DBT) to Gantenerumab vs Global - OLE Period: Placebo (DBT) to Gantenerumab: OLE Period: Number of Participants With at Least One AEs
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Global - OLE Period: Gantenerumab (DBT) to Gantenerumab vs Global - OLE Period: Placebo (DBT) to Gantenerumab: OLE Period: Number of Participants With at Least One AEs. Trial comparisons, record NCT03444870-52c2b985. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03444870-52c2b985
On this page
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 | 0.8 | 0.584 | 0.919 | wilson | |
| Risk in group 2 | 0.889 | 0.565 | 0.98 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0889 | -0.323 | 0.256 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.9 | 0.655 | 1.24 | log | |
| Odds ratio, group 1 over group 2 | 0.5 | 0.0477 | 5.24 | log | |
| Number needed to treat, for one fewer participant with the outcome on Global - OLE Period: Gantenerumab (DBT) to Gantenerumab than on Global - OLE Period: Placebo (DBT) to Gantenerumab | 11.3 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Global - OLE Period: Gantenerumab (DBT) to Gantenerumab | Participants who received gantenerumab in the DBT period continued receiving gantenerumab, SC injections, 510 mg, Q2W up to Week 34 of the OLE period. | 16 | 20 | OG001 |
| Group 2 | Global - OLE Period: Placebo (DBT) to Gantenerumab | Participants who received gantenerumab matching placebo in the DBT period received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W up to Week 34 of the OLE period. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo. | 8 | 9 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- OLE Period: Number of Participants With at Least One AEs
- Description
- An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
- Time frame
- From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 68 weeks)
- Population
SE analysis set included all participants randomized during the global phase who received at least one dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety analysis set, of which one participant entered OLE period.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
- NCT number
- NCT03444870
- Phases
- PHASE3
- Conditions
- Alzheimer Disease
- Interventions
- Gantenerumab, Placebo
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2024-01-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03444870?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT03444870-52c2b985