Comparison · NCT00527735-37dedda0
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) vs Ipilimumab + Paclitaxel/Carboplatin (Sequential): Number of Participants With NSCLC Who Have Positive Human Antihuman Antibody (HAHA) Status Postbaseline
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. Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) vs Ipilimumab + Paclitaxel/Carboplatin (Sequential): Number of Participants With NSCLC Who Have Positive Human Antihuman Antibody (HAHA) Status Postbaseline. Trial comparisons, record NCT00527735-37dedda0. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00527735-37dedda0
On this page
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 | 0.0328 | 0.00904 | 0.112 | wilson | |
| Risk in group 2 | 0.0179 | 0.00316 | 0.0945 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0149 | -0.0653 | 0.0954 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.84 | 0.171 | 19.7 | log | |
| Odds ratio, group 1 over group 2 | 1.86 | 0.164 | 21.1 | log | |
| Number needed to treat, for one more participant with the outcome on Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) than on Ipilimumab + Paclitaxel/Carboplatin (Sequential) | 67 | 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 | Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) | During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure. | 2 | 61 | OG000 |
| Group 2 | Ipilimumab + Paclitaxel/Carboplatin (Sequential) | During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure. | 1 | 56 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With NSCLC Who Have Positive Human Antihuman Antibody (HAHA) Status Postbaseline
- Description
An electrochemilumiluminescent immunoassay was used to detect HAHA antibodies to ipilimumab in human serum. Baseline, either negative or positive, is the maximum of all measurements closest and prior to the first ipilimumab dose. Positive status postbaseline=participants with an increase in HAHA measurement from baseline.
- Time frame
- Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
- Population
- Participants with at least 1 HAHA measurement prior to and at least 1 after the first ipilimumab dose and with an increase in HAHA measurement from baseline.
Source ClinicalTrials.gov
Trial
- Title
- Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)
- NCT number
- NCT00527735
- Phases
- PHASE2
- Conditions
- Lung Cancer, Small Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung
- Interventions
- Ipilimumab, Placebo, Paclitaxel, Carboplatin
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2012-07-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00527735?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.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT00527735-37dedda0