Trial · NCT00703937
Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Standard of Care in Treating Iron Deficiency Anemia
NCT00703937, Phase 3, Completed, American Regent, Inc.; results first posted 2013-11-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Standard of Care in Treating Iron Deficiency Anemia. Trials, record NCT00703937. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00703937
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Standard of Care in Treating Iron Deficiency Anemia
- NCT number
- NCT00703937
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 708 participants, actual
- Lead sponsor
- American Regent, Inc.
- Conditions
- Anemia
- Interventions
- Ferric Carboxymaltose (FCM), Standard Medical Care (SMC) for the treatment of IDA
- First posted
- 2008-06-24
- Last updated
- 2018-02-20
- Results first posted
- 2013-11-25
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety, as Defined by the Occurence of Serious Adverse Events (SAE's), of FCM Compared to SMC | First administration of FCM, or Day 0 for SMC subjects, through end of study (Day 42) or 28 days after the last dose of study drug (FCM or SMC) whichever was longer | Safety, as defined by the occurence of serious adverse events (SAE's), of FCM compared to SMC in the treatment of IDA in subjects who were not dialysis dependent |
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 | Safety, as Defined by the Occurence of Serious Adverse Events (SAE's), of FCM Compared to SMC | First administration of FCM, or Day 0 for SMC subjects, through end of study (Day 42) or 28 days after the last dose of study drug (FCM or SMC) whichever was longer | 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 |
|---|---|---|---|---|---|
| Safety, as Defined by the Occurence of Serious Adverse Events (SAE's), of FCM Compared to SMC | Ferric Carboxymaltose (FCM) | 17 | participants | ||
| Safety, as Defined by the Occurence of Serious Adverse Events (SAE's), of FCM Compared to SMC | Standard Medical Care (SMC) for the Treatment of IDA | 11 | 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) | 343 | |
| Overall Study | STARTED | Standard Medical Care (SMC) for the Treatment of IDA | 360 | |
| Overall Study | COMPLETED | Ferric Carboxymaltose (FCM) | 278 | |
| Overall Study | COMPLETED | Standard Medical Care (SMC) for the Treatment of IDA | 267 | |
| Overall Study | NOT COMPLETED | Ferric Carboxymaltose (FCM) | 65 | |
| Overall Study | NOT COMPLETED | Standard Medical Care (SMC) for the Treatment of IDA | 93 |
Source ClinicalTrials.gov
Adverse events56
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) | 12 | 343 | |
| other | Constipation | Gastrointestinal disorders | Standard Medical Care (SMC) for the Treatment of IDA | 26 | 360 | |
| other | Nausea | Gastrointestinal disorders | Ferric Carboxymaltose (FCM) | 14 | 343 | |
| other | Nausea | Gastrointestinal disorders | Standard Medical Care (SMC) for the Treatment of IDA | 27 | 360 | |
| other | Headache | Nervous system disorders | Ferric Carboxymaltose (FCM) | 16 | 343 | |
| other | Headache | Nervous system disorders | Standard Medical Care (SMC) for the Treatment of IDA | 18 | 360 | |
| serious | Anemia | Blood and lymphatic system disorders | Ferric Carboxymaltose (FCM) | 1 | 343 | |
| serious | Anemia | Blood and lymphatic system disorders | Standard Medical Care (SMC) for the Treatment of IDA | 2 | 360 | |
| serious | Atrial fibrillation | Cardiac disorders | Ferric Carboxymaltose (FCM) | 1 | 343 | |
| serious | Atrial fibrillation | Cardiac disorders | Standard Medical Care (SMC) for the Treatment of IDA | 0 | 360 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 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) for the Treatment of IDA | ||
| Total, other adverse events | Ferric Carboxymaltose (FCM) | 41 | 343 |
| Total, other adverse events | Standard Medical Care (SMC) for the Treatment of IDA | 71 | 360 |
| Total, serious adverse events | Ferric Carboxymaltose (FCM) | 17 | 343 |
| Total, serious adverse events | Standard Medical Care (SMC) for the Treatment of IDA | 11 | 360 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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) for the Treatment of IDA: Safety, as Defined by the Occurence of Serious Adverse Events (SAE's), of FCM Compared to SMC | Trial comparisons |
| Ferric Carboxymaltose (FCM) vs Standard Medical Care (SMC) for the Treatment of IDA: 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/NCT00703937
GET https://conductscience.org/api/trials/v1/NCT00703937/events?page=2