Trial · NCT03525834
Safety and Efficacy of Everolimus (Afinitor®) in Chinese Adult Patients With Angiomyolipoma Associated With Tuberous Sclerosis Complex.
NCT03525834, Phase 4, Completed, Novartis Pharmaceuticals; results first posted 2021-09-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Everolimus (Afinitor®) in Chinese Adult Patients With Angiomyolipoma Associated With Tuberous Sclerosis Complex. Trials, record NCT03525834. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03525834
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Everolimus (Afinitor®) in Chinese Adult Patients With Angiomyolipoma Associated With Tuberous Sclerosis Complex.
- NCT number
- NCT03525834
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 40 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Renal Angiomyolipoma
- Interventions
- Everolimus
- First posted
- 2018-05-16
- Last updated
- 2021-09-09
- Results first posted
- 2021-09-09
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 52 weeks | Percentage of participants with AEs and SAEs including significant changes from baseline in vital signs, electrocardiograms and laboratory parameters (laboratory assessments included hematology, biochemistry, coagulation and urinalysis) qualifying and reported as AEs. The percentage of participants in each category is reported in the table. |
| Secondary | Percentage of Participants With Best Overall Response (BOR) Status of Angiomyolipoma (AML) Response During Maximum Treatment Duration of 48 Weeks | Baseline, 48 weeks | BOR status is the best status recorded from start of treatment until disease progression. AML response status: reduction in AML volume of at least 50% relative to screening AML. In addition, AML response have to satisfy: no new AML ≥ 1 cm in longest diameter are identified, neither kidney increases in volume by more than 20% from nadir (where nadir is the lowest kidney volume at the screening), the participant does not have any angiomyolipoma-related bleeding of grade equal or over 2 (as defined by NCI CTCAE, version 4.03). Up to five of the largest measurable lesions (≥ 1 cm in longest diameter) in each kidney were measured at screening via Magnetic Resonance Imaging/Computed tomography (MRI/CT) and were defined as screening AML. The sum of the volumes of these individual lesions was defined as AML volume and it was measured at each assessment during the trial. Increases in the AML volume were evidence of worsening AML, decreases were evidence of clinical response. |
| Secondary | Percentage of Participants With Best Overall Response Status of Angiomyolipoma (AML) Progression During Maximum Treatment Duration of 48 Weeks | Baseline, 48 weeks | AML progression status is defined as one or more of the following: an increase from nadir of 25% or more in AML volume to a value greater than screening AML (where nadir is the lowest AML volume obtained for the participant previously in the trial), the appearance of a new AML ≥ 1.0 cm in longest diameter, an increase from nadir of 20% or more in the volume of either kidney to a value greater than screening (where nadir is the lowest kidney volume obtained for the participant previously in the trial), angiomyolipoma-related bleeding grade ≥2 (as defined by NCI CTCAE, version 4.03). Up to five of the largest measurable lesions (≥ 1 cm in longest diameter) in each kidney were measured at screening via Magnetic Resonance Imaging/Computed tomography (MRI/CT) and were defined as screening AML. The sum of the volumes of these individual lesions was defined as AML volume and it was measured at each assessment during the trial. Increases in the AML volume were evidence of worsening AML. |
| Secondary | Percentage of Participants With Severe Renal Impairment | Baseline, 48 weeks | Renal impairment is defined as calculated Creatinine Clearance (CrCl) \< 30 mL/min. CrCl was measured at baseline and at four other time points; only the baseline and the worst post-baseline value for every participant were counted (lowest value for CrCl). Creatinine clearance was estimated using the Cockcroft-Gault formula: creatinine clearance (mL/minute) = urine creatinine concentration (mL/dL) x volume of urine (mL/24 hour) / plasma creatinine concentration (mg/dL) x 1440 minute/24 hour |
| Secondary | Percentage of Participants With NCI CTCA Grade 3/4 Serum Creatinine | Baseline, 48 weeks | NCI CTCAE grade 3/4 serum creatinine is defined as \> 3.0 x upper limits of normal (ULN). Serum creatinine was measured at baseline and at four other time points; only the worst post-baseline value for every participant was counted (highest value for serum creatinine). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 52 weeks | All participants who received at least one dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Best Overall Response (BOR) Status of Angiomyolipoma (AML) Response During Maximum Treatment Duration of 48 Weeks | Baseline, 48 weeks | All participants who received at least one dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Best Overall Response Status of Angiomyolipoma (AML) Progression During Maximum Treatment Duration of 48 Weeks | Baseline, 48 weeks | All participants who received at least one dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Severe Renal Impairment | Baseline, 48 weeks | All participants who received at least one dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With NCI CTCA Grade 3/4 Serum Creatinine | Baseline, 48 weeks | All participants who received at least one dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Everolimus | AEs | 40 | Participants | |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Everolimus | Treatment-related AEs | 39 | Participants | |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Everolimus | SAEs | 6 | Participants | |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Everolimus | Treatment-related SAEs | 2 | Participants | |
| Percentage of Participants With Best Overall Response (BOR) Status of Angiomyolipoma (AML) Response During Maximum Treatment Duration of 48 Weeks | Everolimus | 28 | Participants | ||
| Percentage of Participants With Best Overall Response Status of Angiomyolipoma (AML) Progression During Maximum Treatment Duration of 48 Weeks | Everolimus | 1 | Participants | ||
| Percentage of Participants With Severe Renal Impairment | Everolimus | Baseline | 0 | Participants | |
| Percentage of Participants With Severe Renal Impairment | Everolimus | Post-baseline, 48 weeks | 1 | Participants | |
| Percentage of Participants With NCI CTCA Grade 3/4 Serum Creatinine | Everolimus | Baseline | 0 | Participants | |
| Percentage of Participants With NCI CTCA Grade 3/4 Serum Creatinine | Everolimus | Post-baseline, 48 weeks | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Everolimus | 40 | |
| Overall Study | COMPLETED | Everolimus | 39 | |
| Overall Study | NOT COMPLETED | Everolimus | 1 |
Source ClinicalTrials.gov
Adverse events50
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 | Anaemia | Blood and lymphatic system disorders | Everolimus | 8 | 40 | |
| other | Angular cheilitis | Gastrointestinal disorders | Everolimus | 3 | 40 | |
| other | Diarrhoea | Gastrointestinal disorders | Everolimus | 4 | 40 | |
| other | Mouth ulceration | Gastrointestinal disorders | Everolimus | 15 | 40 | |
| other | Stomatitis | Gastrointestinal disorders | Everolimus | 18 | 40 | |
| other | Toothache | Gastrointestinal disorders | Everolimus | 2 | 40 | |
| other | Asthenia | General disorders | Everolimus | 2 | 40 | |
| other | Pyrexia | General disorders | Everolimus | 6 | 40 | |
| other | Folliculitis | Infections and infestations | Everolimus | 5 | 40 | |
| other | Nasopharyngitis | Infections and infestations | Everolimus | 4 | 40 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Everolimus | 0 | 40 |
| Total, other adverse events | Everolimus | 39 | 40 |
| Total, serious adverse events | Everolimus | 6 | 40 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT03525834
GET https://conductscience.org/api/trials/v1/NCT03525834/events?page=2