Comparison · NCT03464136-sae
Adalimumab vs Ustekinumab: 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. Adalimumab vs Ustekinumab: serious adverse events. Trial comparisons, record NCT03464136-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03464136-sae
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 | 0.195 | 0.145 | 0.256 | wilson | |
| Risk in group 2 | 0.152 | 0.108 | 0.21 | wilson | |
| Risk difference, group 1 minus group 2 | 0.043 | -0.033 | 0.118 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.28 | 0.826 | 1.99 | log | |
| Odds ratio, group 1 over group 2 | 1.35 | 0.795 | 2.3 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Adalimumab than on Ustekinumab | 23.2 | from the risk difference interval | the interval includes no difference |
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 | Adalimumab | Participants received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams \[mg\], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w). | 38 | 195 | EG000 |
| Group 2 | Ustekinumab | Participants received IV infusion of ustekinumab (approximately 6 milligram/kilogram \[mg/kg\]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated q2w dosing intervals. | 29 | 191 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 81 weeks
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year
- NCT number
- NCT03464136
- Phases
- PHASE3
- Conditions
- Crohn Disease
- Interventions
- Placebo for Ustekinumab, Placebo for Adalimumab, Ustekinumab (6 mg/kg), Ustekinumab (90 mg), Adalimumab (40 mg)
- Lead sponsor
- Janssen Scientific Affairs, LLC
- Results first posted
- 2022-01-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03464136?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/NCT03464136-sae