Comparison · NCT01127178-sae
Dose Escalation Part: E7016 4 mg/kg/Day + Temozolomide 150 mg/m^2 vs Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2: 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. Dose Escalation Part: E7016 4 mg/kg/Day + Temozolomide 150 mg/m^2 vs Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2: serious adverse events. Trial comparisons, record NCT01127178-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01127178-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 | 0.556 | 0.267 | 0.811 | wilson | |
| Risk in group 2 | 0.333 | 0.0615 | 0.792 | wilson | |
| Risk difference, group 1 minus group 2 | 0.222 | -0.32 | 0.595 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.67 | 0.303 | 9.16 | log | |
| Odds ratio, group 1 over group 2 | 2.5 | 0.162 | 38.6 | log | |
Number needed to harm, for one more participant with a serious adverse event on Dose Escalation Part: E7016 4 mg/kg/Day + Temozolomide 150 mg/m^2 than on Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2 | 4.5 | 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 | Dose Escalation Part: E7016 4 mg/kg/Day + Temozolomide 150 mg/m^2 | Participants received single oral dose of 4 mg/kg/day E7016 capsule on Day -7 for PK analysis, followed by once daily dose from days 1 to 5 in combination with temozolomide 150 mg/m\^2 capsule and alone on days 6 and 7 of Cycle 1 (cycle length=28 days) in Treatment Phase. Participants who completed the Treatment Phase entered the Extension Phase of Dose Escalation Part and continued the treatment in Extension Phase in same manner of Treatment Phase until unacceptable toxicity, disease progression, termination by the treating investigator, withdrawal of consent, termination of the program by the sponsor, or treatment delay \>2 weeks for recovery of toxicity. | 5 | 9 | EG000 |
| Group 2 | Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2 | Participants received single oral dose of 8 mg/kg/day E7016 capsule on Day -7 for PK analysis, followed by once daily dose from days 1 to 5 in combination with temozolomide 150 mg/m\^2 capsule and alone on days 6 and 7 of Cycle 1 (cycle length=28 days) in Treatment Phase. Participants who completed the Treatment Phase entered the Extension Phase of Dose Escalation Part and continued the treatment in Extension Phase in same manner of Treatment Phase until unacceptable toxicity, disease progression, termination by the treating investigator, withdrawal of consent, termination of the program by the sponsor, or treatment delay \>2 weeks for recovery of toxicity. | 1 | 3 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From date of first dose up to 30 days after the last dose of study drug (up to 45 weeks)
Source ClinicalTrials.gov
Trial
- Title
- Study of Poly (ADP-Ribose) Polymerase (PARP) Inhibitor E7016 in Combination With Temozolomide in Subjects With Advanced Solid Tumors
- NCT number
- NCT01127178
- Phases
- PHASE1
- Conditions
- Solid Tumors
- Interventions
- E7016 + TMZ
- Lead sponsor
- Eisai Inc.
- Results first posted
- 2024-10-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01127178?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.
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