Comparison · NCT03301220-sae
Arm A: Active Monitoring (ACTM) vs Arm B: Daratumumab SC: serious adverse events
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. Arm A: Active Monitoring (ACTM) vs Arm B: Daratumumab SC: serious adverse events. Trial comparisons, record NCT03301220-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03301220-sae
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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 | 0.194 | 0.145 | 0.255 | wilson | |
| Risk in group 2 | 0.29 | 0.231 | 0.358 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0963 | -0.18 | -0.0111 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.668 | 0.466 | 0.959 | log | |
| Odds ratio, group 1 over group 2 | 0.588 | 0.367 | 0.943 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm A: Active Monitoring (ACTM) than on Arm B: Daratumumab SC | 10.4 | 5.56 | 90.1 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Arm A: Active Monitoring (ACTM) | Participants in the active monitoring group did not receive any study medication but underwent disease evaluations for every 12 weeks until disease progression (PD) as those randomized to receive daratumumab. | 38 | 196 | EG000 |
| Group 2 | Arm B: Daratumumab SC | Participants received daratumumab 1800 milligrams (mg) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 units per milliliter (U/mL) as subcutaneous (SC) injection once every week (Q1W) (Days 1, 8, 15, and 22 of each week) in Cycles 1 and 2, every 2 weeks (Q2W) (Days 1 and 15) from Cycle 3 to Cycle 6, and thereafter every 4 weeks (Day 1) from Cycle 7 to Cycle 39, for a maximum of 36 months, or until confirmed disease progression, unacceptable toxicity or withdrawal from the study treatment. In addition, disease evaluations were performed every 12 weeks until PD. Each treatment cycle was 28 days. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal or study end, whichever occurred first (up to 8 years). | 56 | 193 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
Source ClinicalTrials.gov
Trial
- Title
- A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma
- NCT number
- NCT03301220
- Phases
- PHASE3
- Conditions
- Smoldering Multiple Myeloma
- Interventions
- Daratumumab SC: daratumumab + rHuPH20
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2025-12-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03301220?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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