Comparison · NCT04711135-578930e3
GEP-NET vs PPGL: Incidence of Adverse Events (AEs) and Lab Toxicities After 1st Lutathera Administration
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. GEP-NET vs PPGL: Incidence of Adverse Events (AEs) and Lab Toxicities After 1st Lutathera Administration. Trial comparisons, record NCT04711135-578930e3. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04711135-578930e3
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 | 1 | 0.51 | 1 | wilson | |
| Risk in group 2 | 0.857 | 0.487 | 0.974 | wilson | |
| Risk difference, group 1 minus group 2 | 0.143 | -0.361 | 0.513 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.17 | 0.862 | 1.58 | log | |
| 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 GEP-NET than on PPGL | 7 | 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 | GEP-NET | All eligible participants with Gastroenteropancreatic neuroendocrine tumor (GEP-NET) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution. | 4 | 4 | OG000 |
| Group 2 | PPGL | All eligible participants with Pheochromocytoma and paraganglioma (PPGL) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution. | 6 | 7 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Incidence of Adverse Events (AEs) and Lab Toxicities After 1st Lutathera Administration
- Description
- Safety in adolescents with SSTR-positive GEP-NETs and PPGLs as a pooled cohort was evaluated through the incidence of AEs and laboratory abnormalities after the first Lutathera dose.
- Time frame
- during first cycle of Lutetium [Lu 177] dotatate treatment (Cycle = 56 days)
- Population
- Safety Set: The Safety Set included all participants that received at least one dose of Lutathera.
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs
- NCT number
- NCT04711135
- Phases
- PHASE2
- Conditions
- Gastroenteropancreatic Neuroendocrine Tumors, Pheochromocytoma, Paraganglioma
- Interventions
- Lutetium [177Lu] oxodotreotide/dotatate
- Lead sponsor
- Advanced Accelerator Applications
- Results first posted
- 2024-11-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04711135?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/NCT04711135-578930e3