Trial · NCT00704353
Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia
NCT00704353, 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 a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia. Trials, record NCT00704353. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00704353
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia
- NCT number
- NCT00704353
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 735 participants, actual
- Lead sponsor
- American Regent, Inc.
- Conditions
- Anemia
- Interventions
- Ferric Carboxymaltose, Standard Medical Care (SMC)
- 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 | Number of Participants With Treatment-emergent Serious Adverse Events (SAE's) | through 30 days after the last dose of study drug (FCM or SMC for the treatment of IDA) |
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 | Number of Participants With Treatment-emergent Serious Adverse Events (SAE's) | through 30 days after the last dose of study drug (FCM or SMC for the treatment of IDA) | 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 |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Serious Adverse Events (SAE's) | Ferric Carboxymaltose (FCM) | 5 | participants | ||
| Number of Participants With Treatment-emergent Serious Adverse Events (SAE's) | Standard Medical Care | 9 | 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) | 366 | |
| Overall Study | STARTED | Standard Medical Care | 369 | |
| Overall Study | COMPLETED | Ferric Carboxymaltose (FCM) | 268 | |
| Overall Study | COMPLETED | Standard Medical Care | 255 | |
| Overall Study | NOT COMPLETED | Ferric Carboxymaltose (FCM) | 98 | |
| Overall Study | NOT COMPLETED | Standard Medical Care | 114 |
Source ClinicalTrials.gov
Adverse events34
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 |
|---|---|---|---|---|---|---|
| serious | Iron deficiency anemia | Blood and lymphatic system disorders | Ferric Carboxymaltose (FCM) | 1 | 366 | |
| serious | Iron deficiency anemia | Blood and lymphatic system disorders | Standard Medical Care | 0 | 369 | |
| serious | Leukocytosis | Blood and lymphatic system disorders | Ferric Carboxymaltose (FCM) | 1 | 366 | |
| serious | Leukocytosis | Blood and lymphatic system disorders | Standard Medical Care | 0 | 369 | |
| serious | Angina pectoris | Cardiac disorders | Ferric Carboxymaltose (FCM) | 0 | 366 | |
| serious | Angina pectoris | Cardiac disorders | Standard Medical Care | 1 | 369 | |
| serious | Atrial fibrillation | Cardiac disorders | Ferric Carboxymaltose (FCM) | 1 | 366 | |
| serious | Atrial fibrillation | Cardiac disorders | Standard Medical Care | 0 | 369 | |
| serious | Cardiomyopathy | Cardiac disorders | Ferric Carboxymaltose (FCM) | 1 | 366 | |
| serious | Cardiomyopathy | Cardiac disorders | Standard Medical Care | 0 | 369 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 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 | ||
| Total, other adverse events | Ferric Carboxymaltose (FCM) | 0 | 366 |
| Total, other adverse events | Standard Medical Care | 0 | 369 |
| Total, serious adverse events | Ferric Carboxymaltose (FCM) | 5 | 366 |
| Total, serious adverse events | Standard Medical Care | 9 | 369 |
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: Number of Participants With Treatment-emergent Serious Adverse Events (SAE's) | Trial comparisons |
| Ferric Carboxymaltose (FCM) vs Standard Medical Care: 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/NCT00704353
GET https://conductscience.org/api/trials/v1/NCT00704353/events?page=2