Comparison · NCT00441142-sae
Phase I & Phase II-Arm B Pts: RT + TMZ + Vandetanib vs Phase II-Arm A Pts (Control Group): RT + TMZ: serious adverse events
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. Phase I & Phase II-Arm B Pts: RT + TMZ + Vandetanib vs Phase II-Arm A Pts (Control Group): RT + TMZ: serious adverse events. Trial comparisons, record NCT00441142-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00441142-sae
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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 | 0.634 | 0.526 | 0.73 | wilson | |
| Risk in group 2 | 0.5 | 0.332 | 0.668 | wilson | |
| Risk difference, group 1 minus group 2 | 0.134 | -0.066 | 0.328 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.27 | 0.855 | 1.88 | log | |
| Odds ratio, group 1 over group 2 | 1.73 | 0.745 | 4.04 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Phase I & Phase II-Arm B Pts: RT + TMZ + Vandetanib than on Phase II-Arm A Pts (Control Group): RT + TMZ | 7.45 | 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 | Phase I & Phase II-Arm B Pts: RT + TMZ + Vandetanib | The Induction Phase:~ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses. | 52 | 82 | EG000 |
| Group 2 | Phase II-Arm A Pts (Control Group): RT + TMZ | The Induction Phase:~Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\]. | 15 | 30 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Source ClinicalTrials.gov
Trial
- Title
- Zactima With Temodar During Radiation Treatment for Newly Diagnosed Stage IV Brain Tumors
- NCT number
- NCT00441142
- Phases
- PHASE1, PHASE2
- Conditions
- Glioblastoma Multiforme, Gliosarcoma
- Interventions
- ZD6474, temozolomide, Radiation Therapy
- Lead sponsor
- Patrick Y. Wen, MD
- Results first posted
- 2015-03-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00441142?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.
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GET https://conductscience.org/api/comparisons/v1/NCT00441142-sae