Comparison · NCT02643420-e8173381
Arm 1: SPI-2012 and TC vs Arm 2: Pegfilgrastim and TC: Number of Participants With Neutropenic Complications in Cycle 1
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. Arm 1: SPI-2012 and TC vs Arm 2: Pegfilgrastim and TC: Number of Participants With Neutropenic Complications in Cycle 1. Trial comparisons, record NCT02643420-e8173381. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02643420-e8173381
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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 | 0.0408 | 0.0208 | 0.0785 | wilson | |
| Risk in group 2 | 0.0381 | 0.0194 | 0.0734 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00272 | -0.0378 | 0.0447 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.07 | 0.41 | 2.8 | log | |
| Odds ratio, group 1 over group 2 | 1.07 | 0.395 | 2.92 | log | |
| Number needed to treat, for one more participant with the outcome on Arm 1: SPI-2012 and TC than on Arm 2: Pegfilgrastim and TC | 368 | 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 | Arm 1: SPI-2012 and TC | Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. | 8 | 196 | OG000 |
| Group 2 | Arm 2: Pegfilgrastim and TC | Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. | 8 | 210 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Neutropenic Complications in Cycle 1
- Description
- Neutropenic complications refer to hospitalizations due to neutropenic events and/or the use of anti-infectives due to neutropenia.
- Time frame
- Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)
- Population
- The ITT population included all participants who was randomized.
Source ClinicalTrials.gov
Trial
- Title
- SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE)
- NCT number
- NCT02643420
- Phases
- PHASE3
- Conditions
- Neutropenia, Breast Cancer
- Interventions
- SPI-2012, Pegfilgrastim, Docetaxel, Cyclophosphamide
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Results first posted
- 2022-03-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02643420?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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