Comparison · NCT03444870-505e36d2
Global - DBT Period: Gantenerumab vs Global - DBT Period: Placebo: DBT Period: Number of Participants With Injection-Site Reactions
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. Global - DBT Period: Gantenerumab vs Global - DBT Period: Placebo: DBT Period: Number of Participants With Injection-Site Reactions. Trial comparisons, record NCT03444870-505e36d2. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03444870-505e36d2
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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 | 0.187 | 0.155 | 0.223 | wilson | |
| Risk in group 2 | 0.0894 | 0.067 | 0.118 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0975 | 0.0547 | 0.14 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.09 | 1.49 | 2.93 | log | |
| Odds ratio, group 1 over group 2 | 2.34 | 1.59 | 3.44 | log | |
| Number needed to treat, for one more participant with the outcome on Global - DBT Period: Gantenerumab than on Global - DBT Period: Placebo | 10.3 | 7.13 | 18.3 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Global - DBT Period: Gantenerumab | Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period. | 94 | 503 | OG001 |
| Group 2 | Global - DBT Period: Placebo | Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period. | 43 | 481 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- DBT Period: Number of Participants With Injection-Site Reactions
- Description
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution. Local injection reactions (or injection site reactions) are defined as AEs related to the injection site that occur during or within 24 hours after study drug administration that are judged to be related to the study drug injection.
- Time frame
- From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 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, four participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety analysis set.
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.
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