Comparison · NCT00567502-d20fe3cd
XAGRID vs Other (Cytoreductives): Number of Participants With Suspected Serious Adverse Reaction (SSAR) Events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. XAGRID vs Other (Cytoreductives): Number of Participants With Suspected Serious Adverse Reaction (SSAR) Events. Trial comparisons, record NCT00567502-d20fe3cd. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00567502-d20fe3cd
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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 | 0.0285 | 0.0207 | 0.039 | wilson | |
| Risk in group 2 | 0.0228 | 0.0181 | 0.0287 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00565 | -0.00409 | 0.0172 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.25 | 0.842 | 1.85 | log | |
| Odds ratio, group 1 over group 2 | 1.26 | 0.838 | 1.88 | log | |
| Number needed to treat, for one more participant with the outcome on XAGRID than on Other (Cytoreductives) | 177 | 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 | XAGRID | Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years. | 37 | 1,300 | OG000 |
| Group 2 | Other (Cytoreductives) | Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years. Other Cytoreductives included Hydroxyurea, Interferonalpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32. | 70 | 3,069 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Suspected Serious Adverse Reaction (SSAR) Events
- Description
SSAR: serious adverse event (SAE) that was considered related to cytoreductive therapy. SAE: any untoward medical occurrence that at any dose resulted in death, life-threatening (at the time of the event), in-patient hospitalization/prolongation of existing hospitalization (elective hospitalizations/procedures for pre-existing conditions that had not worsened were excluded), resulted in persistent or significant disability/incapacity or congenital abnormality/birth defect. Relatedness (suspected/not suspected) to XAGRID or other cytoreductive theraphy was determined by the investigator. As for SSARs, it was important to consider whether the events were related to XAGRID or other cytoreductive therapy. A participant was included in Xagrid or other treatment group based on treatment exposure, participants received Xagrid + Other was counted both in Xagrid and other treatment group.
- Time frame
- Up to 5 years
- Population
Overall treatment safety population. All events/data were allocated to the treatment that a participant was receiving at the time of the event/assessment. Participants who had exposed to XAGRID (alone or in combination with other) was counted in Xagrid arm and those who had received other ET therapy in the Other (Cytoreductives).
Source ClinicalTrials.gov
Trial
- Title
- Safety and Pregnancy Outcomes in Thrombocythemia Patients Exposed to XAGRID® (Anagrelide Hydrochloride) Compared to Other Treatments
- NCT number
- NCT00567502
- Phases
- Conditions
- Thrombocythemia, Essential
- Interventions
- Lead sponsor
- Shire
- Results first posted
- 2015-11-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00567502?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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