Trial · NCT01298323
Study to Determine if Contacting Patients With MTC More Frequently Results in Earlier Detection and Treatment of Signs and Symptoms of AEs and Thus a Decrease in the Percentage of Time Patients Experience AEs During First 12 Months on Vandetanib Treatment
NCT01298323, Phase 3, Completed, Sanofi; results first posted 2014-11-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Determine if Contacting Patients With MTC More Frequently Results in Earlier Detection and Treatment of Signs and Symptoms of AEs and Thus a Decrease in the Percentage of Time Patients Experience AEs During First 12 Months on Vandetanib Treatment. Trials, record NCT01298323. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01298323
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study to Determine if Contacting Patients With MTC More Frequently Results in Earlier Detection and Treatment of Signs and Symptoms of AEs and Thus a Decrease in the Percentage of Time Patients Experience AEs During First 12 Months on Vandetanib Treatment
- NCT number
- NCT01298323
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 205 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Locally Advanced or Metastatic Medullary Thyroid Cancer, Medullary Thyroid Cancer
- Interventions
- Patient outreach, Vandetanib
- First posted
- 2011-02-17
- Last updated
- 2026-04-17
- Other registries' IDs
- eudract:2010-023428-26
- Results first posted
- 2014-11-24
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Time a Patient Experienced at Least 1 AE of CTCAE Grade >=2 in First 12 Months of Receiving Vandetanib in Patients Who Participated in Patient Outreach Program. | 12 months | The primary endpoint is the percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of treatment with vandetanib. If the patient discontinues treatment with vandetanib prior to the 12-month time point for any reason, this endpoint will be the time a patient experienced at least one AE of CTCAE grade 2 or higher as a percentage of the time the patient was receiving vandetanib. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Time a Patient Experienced at Least 1 AE of CTCAE Grade >=2 in First 12 Months of Receiving Vandetanib in Patients Who Participated in Patient Outreach Program. | 12 months | Number of Months Analyzed is the cumulative sum of number of months that all the participants were present in the study. | Percentage of days | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Time a Patient Experienced at Least 1 AE of CTCAE Grade >=2 in First 12 Months of Receiving Vandetanib in Patients Who Participated in Patient Outreach Program. | Vandetanib 300 mg+Outreach Program | 51.65 | Standard Deviation 35.548 | Percentage of days | |
| Percentage of Time a Patient Experienced at Least 1 AE of CTCAE Grade >=2 in First 12 Months of Receiving Vandetanib in Patients Who Participated in Patient Outreach Program. | Vandetanib 300 mg | 45.19 | Standard Deviation 36.347 | Percentage of days |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vandetanib 300mg | 102 | |
| Overall Study | STARTED | Vandetanib 300mg + Outreach Program | 103 | |
| Overall Study | Ongoing | Vandetanib 300mg | 55 | |
| Overall Study | Ongoing | Vandetanib 300mg + Outreach Program | 55 | |
| Overall Study | COMPLETED | Vandetanib 300mg | 16 | |
| Overall Study | COMPLETED | Vandetanib 300mg + Outreach Program | 15 | |
| Overall Study | NOT COMPLETED | Vandetanib 300mg | 86 | |
| Overall Study | NOT COMPLETED | Vandetanib 300mg + Outreach Program | 88 |
Source ClinicalTrials.gov
Adverse events202
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 | Asthenia | General disorders | Vandetanib 300mg | 12 | 103 | 13 |
| other | Asthenia | General disorders | Vandetanib 300mg + Outreach Program | 12 | 102 | 14 |
| other | Headache | Nervous system disorders | Vandetanib 300mg | 8 | 103 | 9 |
| other | Headache | Nervous system disorders | Vandetanib 300mg + Outreach Program | 12 | 102 | 16 |
| other | Erythema | Skin and subcutaneous tissue disorders | Vandetanib 300mg | 2 | 103 | 2 |
| other | Erythema | Skin and subcutaneous tissue disorders | Vandetanib 300mg + Outreach Program | 6 | 102 | 6 |
| other | Rash | Skin and subcutaneous tissue disorders | Vandetanib 300mg | 25 | 103 | 31 |
| other | Rash | Skin and subcutaneous tissue disorders | Vandetanib 300mg + Outreach Program | 26 | 102 | 28 |
| other | Rash maculo-papular | Skin and subcutaneous tissue disorders | Vandetanib 300mg | 7 | 103 | 7 |
| other | Rash maculo-papular | Skin and subcutaneous tissue disorders | Vandetanib 300mg + Outreach Program | 4 | 102 | 4 |
1 to 10 of 202Source ClinicalTrials.gov
See all 202 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vandetanib 300mg | ||
| Total, all-cause mortality | Vandetanib 300mg + Outreach Program | ||
| Total, other adverse events | Vandetanib 300mg | 89 | 103 |
| Total, other adverse events | Vandetanib 300mg + Outreach Program | 96 | 102 |
| Total, serious adverse events | Vandetanib 300mg | 30 | 103 |
| Total, serious adverse events | Vandetanib 300mg + Outreach Program | 27 | 102 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Vandetanib 300mg vs Vandetanib 300mg + Outreach Program: serious adverse events |
Source Trial comparisons
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/NCT01298323
GET https://conductscience.org/api/trials/v1/NCT01298323/events?page=2