Comparison · NCT00103610-sae
G-CSF Plus Plerixafor vs G-CSF Plus Placebo: 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. G-CSF Plus Plerixafor vs G-CSF Plus Placebo: serious adverse events. Trial comparisons, record NCT00103610-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00103610-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 | 0.0533 | 0.0273 | 0.102 | wilson | |
| Risk in group 2 | 0.069 | 0.0379 | 0.122 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0156 | -0.075 | 0.0419 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.773 | 0.314 | 1.9 | log | |
| Odds ratio, group 1 over group 2 | 0.761 | 0.291 | 1.98 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on G-CSF Plus Plerixafor than on G-CSF Plus Placebo | 64 | 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 | G-CSF Plus Plerixafor | Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected. | 8 | 150 | EG000 |
| Group 2 | G-CSF Plus Placebo | Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected. | 10 | 145 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38).
Source ClinicalTrials.gov
Trial
- Title
- Mobilization of Stem Cells With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma Patients
- NCT number
- NCT00103610
- Phases
- PHASE3
- Conditions
- Lymphoma, Non-Hodgkin
- Interventions
- Granulocyte colony-stimulating factor plus plerixafor, Granulocyte colony-stimulating factor plus placebo
- Lead sponsor
- Genzyme, a Sanofi Company
- Results first posted
- 2010-09-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00103610?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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