Trial Outcomes & Findings for Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients (NCT NCT00548860)
NCT ID: NCT00548860
Last Updated: 2018-02-20
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2018 participants
Primary outcome timeframe
From Day 0 through 30 days after the last dose of study drug.
Results posted on
2018-02-20
Participant Flow
Hospitals and medical clinics
Participant milestones
| Measure |
Ferric Carboxymaltose (FCM)
Intravenous (IV) iron
|
Standard Medical Care (SMC)
SMC for postpartum and heavy uterine bleeding subjects with anemia
|
|---|---|---|
|
Overall Study
STARTED
|
996
|
1022
|
|
Overall Study
COMPLETED
|
860
|
847
|
|
Overall Study
NOT COMPLETED
|
136
|
175
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients
Baseline characteristics by cohort
| Measure |
Ferric Carboxymaltose (FCM)
n=996 Participants
Intravenous (IV) iron
|
Standard Medical Care (SMC)
n=1022 Participants
SMC for postpartum and heavy uterine bleeding subjects with anemia
|
Total
n=2018 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
971 Participants
n=5 Participants
|
995 Participants
n=7 Participants
|
1966 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
31.2 years
STANDARD_DEVIATION 9.36 • n=5 Participants
|
31.4 years
STANDARD_DEVIATION 8.98 • n=7 Participants
|
31.3 years
STANDARD_DEVIATION 9.17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
996 Participants
n=5 Participants
|
1022 Participants
n=7 Participants
|
2018 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
996 participants
n=5 Participants
|
1022 participants
n=7 Participants
|
2018 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Ferric Carboxymaltose (FCM)
n=996 Participants
Intravenous (IV) iron
|
Standard Medical Care (SMC)
n=1022 Participants
SMC for postpartum and heavy uterine bleeding subjects with anemia
|
|---|---|---|
|
Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC.
|
6 participants
|
22 participants
|
Adverse Events
Ferric Carboxymaltose (FCM)
Serious events: 6 serious events
Other events: 9 other events
Deaths: 0 deaths
Standard Medical Care (SMC)
Serious events: 22 serious events
Other events: 79 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ferric Carboxymaltose (FCM)
n=996 participants at risk
Intravenous (IV) iron
|
Standard Medical Care (SMC)
n=1022 participants at risk
SMC for postpartum and heavy uterine bleeding subjects with anemia
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.10%
1/996 • 1 year and 5 months
|
0.00%
0/1022 • 1 year and 5 months
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/996 • 1 year and 5 months
|
0.10%
1/1022 • 1 year and 5 months
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/996 • 1 year and 5 months
|
0.10%
1/1022 • 1 year and 5 months
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/996 • 1 year and 5 months
|
0.10%
1/1022 • 1 year and 5 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/996 • 1 year and 5 months
|
0.10%
1/1022 • 1 year and 5 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.10%
1/996 • 1 year and 5 months
|
0.10%
1/1022 • 1 year and 5 months
|
|
Infections and infestations
Necrotising Fasciitis
|
0.10%
1/996 • 1 year and 5 months
|
0.00%
0/1022 • 1 year and 5 months
|
|
Infections and infestations
Postoperative abscess
|
0.10%
1/996 • 1 year and 5 months
|
0.00%
0/1022 • 1 year and 5 months
|
|
Infections and infestations
Endometritis
|
0.00%
0/996 • 1 year and 5 months
|
0.10%
1/1022 • 1 year and 5 months
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/996 • 1 year and 5 months
|
0.10%
1/1022 • 1 year and 5 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/996 • 1 year and 5 months
|
0.10%
1/1022 • 1 year and 5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/996 • 1 year and 5 months
|
0.10%
1/1022 • 1 year and 5 months
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum hemorrhage
|
0.00%
0/996 • 1 year and 5 months
|
0.20%
2/1022 • 1 year and 5 months
|
|
Pregnancy, puerperium and perinatal conditions
Retained placenta or membranes
|
0.00%
0/996 • 1 year and 5 months
|
0.10%
1/1022 • 1 year and 5 months
|
|
Reproductive system and breast disorders
Uterine hemorrhage
|
0.10%
1/996 • 1 year and 5 months
|
0.49%
5/1022 • 1 year and 5 months
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/996 • 1 year and 5 months
|
0.59%
6/1022 • 1 year and 5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.10%
1/996 • 1 year and 5 months
|
0.49%
5/1022 • 1 year and 5 months
|
Other adverse events
| Measure |
Ferric Carboxymaltose (FCM)
n=996 participants at risk
Intravenous (IV) iron
|
Standard Medical Care (SMC)
n=1022 participants at risk
SMC for postpartum and heavy uterine bleeding subjects with anemia
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.90%
9/996 • 1 year and 5 months
|
7.7%
79/1022 • 1 year and 5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60