Trial · NCT00548860
Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients
NCT00548860, Phase 3, Completed, American Regent, Inc.; results first posted 2015-05-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients. Trials, record NCT00548860. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00548860
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients
- NCT number
- NCT00548860
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,018 participants, actual
- Lead sponsor
- American Regent, Inc.
- Conditions
- Anemia
- Interventions
- Ferric Carboxymaltose, Standard Medical Care (SMC)
- First posted
- 2007-10-24
- Last updated
- 2018-02-20
- Results first posted
- 2015-05-29
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC. | From Day 0 through 30 days after the last dose of study drug. | Evaluate the safety of the maximum administered dose, 15 mg/kg (up to a maximum 1,000 mg) of FCM compared to SMC. The primary safety endpoint was the incidence of Serious Adverse Events (SAE's). |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC. | From Day 0 through 30 days after the last dose of study drug. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC. | Ferric Carboxymaltose (FCM) | 6 | participants | ||
| Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC. | Standard Medical Care (SMC) | 22 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ferric Carboxymaltose (FCM) | 996 | |
| Overall Study | STARTED | Standard Medical Care (SMC) | 1,022 | |
| Overall Study | COMPLETED | Ferric Carboxymaltose (FCM) | 860 | |
| Overall Study | COMPLETED | Standard Medical Care (SMC) | 847 | |
| Overall Study | NOT COMPLETED | Ferric Carboxymaltose (FCM) | 136 | |
| Overall Study | NOT COMPLETED | Standard Medical Care (SMC) | 175 |
Source ClinicalTrials.gov
Adverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Ferric Carboxymaltose (FCM) | 9 | 996 | |
| other | Constipation | Gastrointestinal disorders | Standard Medical Care (SMC) | 79 | 1,022 | |
| serious | Anemia | Blood and lymphatic system disorders | Ferric Carboxymaltose (FCM) | 1 | 996 | |
| serious | Anemia | Blood and lymphatic system disorders | Standard Medical Care (SMC) | 0 | 1,022 | |
| serious | Lymphadenitis | Blood and lymphatic system disorders | Ferric Carboxymaltose (FCM) | 0 | 996 | |
| serious | Lymphadenitis | Blood and lymphatic system disorders | Standard Medical Care (SMC) | 1 | 1,022 | |
| serious | Abdominal adhesions | Gastrointestinal disorders | Ferric Carboxymaltose (FCM) | 0 | 996 | |
| serious | Abdominal adhesions | Gastrointestinal disorders | Standard Medical Care (SMC) | 1 | 1,022 | |
| serious | Abdominal hernia | Gastrointestinal disorders | Ferric Carboxymaltose (FCM) | 0 | 996 | |
| serious | Abdominal hernia | Gastrointestinal disorders | Standard Medical Care (SMC) | 1 | 1,022 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ferric Carboxymaltose (FCM) | ||
| Total, all-cause mortality | Standard Medical Care (SMC) | ||
| Total, other adverse events | Ferric Carboxymaltose (FCM) | 9 | 996 |
| Total, other adverse events | Standard Medical Care (SMC) | 79 | 1,022 |
| Total, serious adverse events | Ferric Carboxymaltose (FCM) | 6 | 996 |
| Total, serious adverse events | Standard Medical Care (SMC) | 22 | 1,022 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28487769 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ferric Carboxymaltose (FCM) vs Standard Medical Care (SMC): Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC. | Trial comparisons |
| Ferric Carboxymaltose (FCM) vs Standard Medical Care (SMC): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00548860
GET https://conductscience.org/api/trials/v1/NCT00548860/events?page=2