Comparison · NCT04633447-c8f21d18
Main Study: Guselkumab vs Main Study: Placebo: Main Study: Number of Participants With Treatment-emergent Serious Adverse Event (SAEs)
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. Main Study: Guselkumab vs Main Study: Placebo: Main Study: Number of Participants With Treatment-emergent Serious Adverse Event (SAEs). Trial comparisons, record NCT04633447-c8f21d18. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04633447-c8f21d18
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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 | 0.171 | 0.081 | 0.327 | wilson | |
| Risk in group 2 | 0 | 0 | 0.176 | wilson | |
| Risk difference, group 1 minus group 2 | 0.171 | -0.0263 | 0.327 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on Main Study: Guselkumab than on Main Study: Placebo | 5.83 | 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 | Main Study: Guselkumab | Initially, participants received 3 intravenous (IV) induction doses of Guselkumab 400 milligrams (mg) every 4 weeks starting from Week 0 up to Week 8 followed by a subcutaneous (SC) maintenance regimen of Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week Glucocorticoid (GC) taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received Guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60. | 6 | 35 | OG000 |
| Group 2 | Main Study: Placebo | Initially, participants received 3 IV induction doses of Placebo matching to Guselkumab 400 mg every 4 weeks starting from Week 0 up to Week 8 followed by a SC maintenance regimen of placebo matching to Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week GC taper regimen. Participants were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and participants enrolled from that point onwards received placebo matching to guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Participants who did not enter LTE continued in the main study till Week 60. | 0 | 18 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Main Study: Number of Participants With Treatment-emergent Serious Adverse Event (SAEs)
- Description
Number of participants with treatment emergent SAEs were reported. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurred at or after the initial administration of study intervention through the end of the main study was considered to be treatment emergent.
- Time frame
- Baseline (Day 1) up to Week 60
- Population
- Safety analysis set included all participants who received at least 1 dose of study intervention.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis
- NCT number
- NCT04633447
- Phases
- PHASE2
- Conditions
- Giant Cell Arteritis
- Interventions
- Guselkumab, Placebo
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2025-07-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04633447?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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