Trial · NCT00411619
Everolimus (RAD001) Therapy of Giant Cell Astrocytoma in Patients With Tuberous Sclerosis Complex
NCT00411619, Phase 1, Phase 2, Completed, Children's Hospital Medical Center, Cincinnati; results first posted 2014-10-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Everolimus (RAD001) Therapy of Giant Cell Astrocytoma in Patients With Tuberous Sclerosis Complex. Trials, record NCT00411619. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00411619
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Everolimus (RAD001) Therapy of Giant Cell Astrocytoma in Patients With Tuberous Sclerosis Complex
- NCT number
- NCT00411619
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Conditions
- Tuberous Sclerosis, Subependymal Giant Cell Astrocytoma
- Interventions
- Everolimus
- First posted
- 2006-12-14
- Last updated
- 2014-10-20
- Results first posted
- 2014-10-20
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number With Observed Adverse Side Effects | During the entire study | |
| Secondary | Overall Reduction in SEGA Tumor Volume. | During the entire study |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number With Observed Adverse Side Effects | During the entire study | participants | NUMBER | |
| SECONDARY | Overall Reduction in SEGA Tumor Volume. | During the entire study | participants | NUMBER |
Source ClinicalTrials.gov
Results by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number With Observed Adverse Side Effects | Everolimus | Upper Respiratory Tract Infection | 26 | participants | |
| Number With Observed Adverse Side Effects | Everolimus | Stomatitis | 25 | participants | |
| Number With Observed Adverse Side Effects | Everolimus | Sinusitis | 15 | participants | |
| Number With Observed Adverse Side Effects | Everolimus | Mouth Ulceration | 14 | participants | |
| Number With Observed Adverse Side Effects | Everolimus | Cellulitis | 12 | participants | |
| Number With Observed Adverse Side Effects | Everolimus | Diarrhoea | 12 | participants | |
| Number With Observed Adverse Side Effects | Everolimus | Gastroenteritis | 12 | participants | |
| Number With Observed Adverse Side Effects | Everolimus | Otitis Media | 11 | participants | |
| Number With Observed Adverse Side Effects | Everolimus | Pyrexia | 10 | participants | |
| Number With Observed Adverse Side Effects | Everolimus | Vomiting | 10 | participants |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Everolimus | 28 | |
| Overall Study | COMPLETED | Everolimus | 22 | |
| Overall Study | NOT COMPLETED | Everolimus | 6 |
Source ClinicalTrials.gov
Adverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper Respiratory Tract Infection | Infections and infestations | Everolimus | 26 | 28 | 26 |
| other | Sinusitis | Infections and infestations | Everolimus | 15 | 28 | 15 |
| other | Cellulitis | Infections and infestations | Everolimus | 12 | 28 | 12 |
| other | Gastroenteritis | Infections and infestations | Everolimus | 12 | 28 | 12 |
| other | Otitis media | Infections and infestations | Everolimus | 11 | 28 | 11 |
| other | Nasopharyngitis | Infections and infestations | Everolimus | 9 | 28 | 9 |
| other | Pharyngitis | Infections and infestations | Everolimus | 8 | 28 | 8 |
| other | Otitis Externa | Infections and infestations | Everolimus | 7 | 28 | 7 |
| other | Pneumonia | Infections and infestations | Everolimus | 6 | 28 | 6 |
| other | Skin infection | Infections and infestations | Everolimus | 6 | 28 | 6 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Everolimus | ||
| Total, other adverse events | Everolimus | 28 | 28 |
| Total, serious adverse events | Everolimus | 9 | 28 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00411619
GET https://conductscience.org/api/trials/v1/NCT00411619/results?page=2