Trial Outcomes & Findings for Comparison of Oral Ferrous Sulfate to Intravenous Ferumoxytol in Antepartum Iron Deficiency Anemia (NCT NCT04253626)
NCT ID: NCT04253626
Last Updated: 2026-06-30
Results Overview
Hemoglobin is measured as g/dL at enrollment and after the study intervention
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
83 participants
Primary outcome timeframe
From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)
Results posted on
2026-06-30
Participant Flow
Can describe study design here, up to 500 characters with spaces
83 participants signed informed consent; 80 were allocated to treatment.
Participant milestones
| Measure |
Oral Iron
Participants are prescribed 1-2 ferrous sulfate 325mg tablets by mouth (based on severity of anemia) until delivery.
|
Intravenous Iron
Participants receive 510mg intravenous iron ferumoxytol, with a maximum of 2 doses based on the baseline hemoglobin level.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
Received allocated intervention
|
39
|
38
|
|
Overall Study
Discontinued intervention
|
6
|
1
|
|
Overall Study
Analyzed for primary outcome
|
38
|
36
|
|
Overall Study
COMPLETED
|
38
|
36
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Oral Ferrous Sulfate to Intravenous Ferumoxytol in Antepartum Iron Deficiency Anemia
Baseline characteristics by cohort
| Measure |
Oral Iron
n=40 Participants
Participants are prescribed 1-2 ferrous sulfate 325mg tablets by mouth (based on severity of anemia) until delivery.
|
Intravenous Iron
n=40 Participants
Participants receive 510mg intravenous iron ferumoxytol, with a maximum of 2 doses based on the baseline hemoglobin level.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.0 years
n=20 Participants
|
32.0 years
n=20 Participants
|
32.0 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=20 Participants
|
40 Participants
n=20 Participants
|
80 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latine
|
11 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
22 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Non Hispanic Asian or Pacific Islander
|
11 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
23 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Non Hispanic Black or African American
|
2 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Non Hispanic White
|
12 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
24 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Other/Unknown
|
4 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=20 Participants
|
40 Participants
n=20 Participants
|
80 Participants
n=40 Participants
|
|
Hemoglobin
|
10.30 g/dL
n=20 Participants
|
10.35 g/dL
n=20 Participants
|
10.30 g/dL
n=40 Participants
|
PRIMARY outcome
Timeframe: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)Population: Participants analyzable for the primary outcome (had data through week 4)
Hemoglobin is measured as g/dL at enrollment and after the study intervention
Outcome measures
| Measure |
Oral Iron
n=38 Participants
Participants are prescribed 1-2 ferrous sulfate 325mg tablets by mouth (based on severity of anemia) until delivery.
|
Intravenous Iron
n=36 Participants
Participants receive 510mg intravenous iron ferumoxytol, with a maximum of 2 doses based on the baseline hemoglobin level.
|
|---|---|---|
|
Median Change in Hemoglobin Value Before and After Intervention
4 weeks
|
10.95 g/dL
Interval 9.88 to 11.18
|
11.45 g/dL
Interval 11.13 to 12.03
|
|
Median Change in Hemoglobin Value Before and After Intervention
Change at 4 weeks
|
0.40 g/dL
Interval -0.1 to 0.8
|
1.10 g/dL
Interval 0.7 to 1.7
|
SECONDARY outcome
Timeframe: From enrollment to delivery or birth admission (average approximately 8 to 12 weeks)Population: Intention to treat; all participants were analyzed according to the group to which they were randomized, regardless of treatment received.
Outcome measures
| Measure |
Oral Iron
n=40 Participants
Participants are prescribed 1-2 ferrous sulfate 325mg tablets by mouth (based on severity of anemia) until delivery.
|
Intravenous Iron
n=40 Participants
Participants receive 510mg intravenous iron ferumoxytol, with a maximum of 2 doses based on the baseline hemoglobin level.
|
|---|---|---|
|
Number of Participants Who Discontinued Treatment
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From enrollment to delivery or birth admission (average approximately 8 to 12 weeks)Population: Intention to treat; all participants were analyzed according to the group to which they were randomized, regardless of treatment received.
Outcome measures
| Measure |
Oral Iron
n=40 Participants
Participants are prescribed 1-2 ferrous sulfate 325mg tablets by mouth (based on severity of anemia) until delivery.
|
Intravenous Iron
n=40 Participants
Participants receive 510mg intravenous iron ferumoxytol, with a maximum of 2 doses based on the baseline hemoglobin level.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events Associated With Treatment
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From enrollment to delivery or birth admission (average approximately 8 to 12 weeks)Population: Intention to treat; all participants were analyzed according to the group to which they were randomized, regardless of treatment received.
Outcome measures
| Measure |
Oral Iron
n=40 Participants
Participants are prescribed 1-2 ferrous sulfate 325mg tablets by mouth (based on severity of anemia) until delivery.
|
Intravenous Iron
n=40 Participants
Participants receive 510mg intravenous iron ferumoxytol, with a maximum of 2 doses based on the baseline hemoglobin level.
|
|---|---|---|
|
Number of Participants Who Need Blood Transfusion Postpartum
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)Population: Participants with data at the respective time point
Score range: 0 to 100 (lower scores indicate more severe symptoms, higher scores correspond to fewer symptoms)
Outcome measures
| Measure |
Oral Iron
n=39 Participants
Participants are prescribed 1-2 ferrous sulfate 325mg tablets by mouth (based on severity of anemia) until delivery.
|
Intravenous Iron
n=38 Participants
Participants receive 510mg intravenous iron ferumoxytol, with a maximum of 2 doses based on the baseline hemoglobin level.
|
|---|---|---|
|
Change in Short Form (SF-)36 General Health Symptom Score
Baseline
|
63 score on a scale
Interval 44.0 to 63.0
|
63 score on a scale
Interval 50.0 to 63.0
|
|
Change in Short Form (SF-)36 General Health Symptom Score
Change at week 4
|
0 score on a scale
Interval -13.0 to 3.0
|
0 score on a scale
Interval -13.0 to 0.0
|
SECONDARY outcome
Timeframe: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)Population: Participants with data at the respective time point
Score range: 0 to 100 (lower scores indicate less physical function, higher scores correspond to more physical function).
Outcome measures
| Measure |
Oral Iron
n=39 Participants
Participants are prescribed 1-2 ferrous sulfate 325mg tablets by mouth (based on severity of anemia) until delivery.
|
Intravenous Iron
n=38 Participants
Participants receive 510mg intravenous iron ferumoxytol, with a maximum of 2 doses based on the baseline hemoglobin level.
|
|---|---|---|
|
Change in Short Form (SF-)36 Physical Functioning Score
Baseline
|
70 score on a scale
Interval 65.0 to 80.0
|
70 score on a scale
Interval 50.0 to 90.0
|
|
Change in Short Form (SF-)36 Physical Functioning Score
Change at week 4
|
-10 score on a scale
Interval -20.0 to 5.0
|
0 score on a scale
Interval -18.0 to 10.0
|
SECONDARY outcome
Timeframe: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)Population: Participants with data at the respective time point
Score range: 0 to 100 (lower scores indicate more limitations, higher scores correspond to fewer limitations).
Outcome measures
| Measure |
Oral Iron
n=38 Participants
Participants are prescribed 1-2 ferrous sulfate 325mg tablets by mouth (based on severity of anemia) until delivery.
|
Intravenous Iron
n=37 Participants
Participants receive 510mg intravenous iron ferumoxytol, with a maximum of 2 doses based on the baseline hemoglobin level.
|
|---|---|---|
|
Change in Short Form (SF-)36 Role Limitations Due to Physical Health Score
Baseline
|
38 score on a scale
Interval 0.0 to 100.0
|
50 score on a scale
Interval 0.0 to 100.0
|
|
Change in Short Form (SF-)36 Role Limitations Due to Physical Health Score
Change at week 4
|
0 score on a scale
Interval 0.0 to 25.0
|
0 score on a scale
Interval 0.0 to 50.0
|
SECONDARY outcome
Timeframe: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)Population: Participants with data at the respective time point
Score range: 0 to 100 (lower scores indicate more fatigue, higher scores correspond to more energy).
Outcome measures
| Measure |
Oral Iron
n=39 Participants
Participants are prescribed 1-2 ferrous sulfate 325mg tablets by mouth (based on severity of anemia) until delivery.
|
Intravenous Iron
n=38 Participants
Participants receive 510mg intravenous iron ferumoxytol, with a maximum of 2 doses based on the baseline hemoglobin level.
|
|---|---|---|
|
Change in Short Form (SF-)36 Energy/Fatigue Score
Baseline
|
50 score on a scale
Interval 30.0 to 60.0
|
40 score on a scale
Interval 23.0 to 60.0
|
|
Change in Short Form (SF-)36 Energy/Fatigue Score
Change at week 4
|
0 score on a scale
Interval -10.0 to 10.0
|
10 score on a scale
Interval 0.0 to 30.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)Population: Participants analyzable for the primary outcome (had data through week 4). Data were stratified by sex.
NIH-required analysis. Hemoglobin is measured as g/dL at enrollment and after the study intervention
Outcome measures
| Measure |
Oral Iron
n=38 Participants
Participants are prescribed 1-2 ferrous sulfate 325mg tablets by mouth (based on severity of anemia) until delivery.
|
Intravenous Iron
n=36 Participants
Participants receive 510mg intravenous iron ferumoxytol, with a maximum of 2 doses based on the baseline hemoglobin level.
|
|---|---|---|
|
Median Change in Hemoglobin Value Before and After Intervention by Sex
Week 4 - Female
|
10.95 g/dL
Interval 9.88 to 11.18
|
11.45 g/dL
Interval 11.13 to 12.03
|
|
Median Change in Hemoglobin Value Before and After Intervention by Sex
Change at Week 4 - Female
|
0.40 g/dL
Interval -0.1 to 0.8
|
1.10 g/dL
Interval 0.7 to 1.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)Population: Participants analyzable for the primary outcome (had data through week 4). Data were stratified by race / ethnicity.
NIH-required analysis. Hemoglobin is measured as g/dL at enrollment and after the study intervention
Outcome measures
| Measure |
Oral Iron
n=38 Participants
Participants are prescribed 1-2 ferrous sulfate 325mg tablets by mouth (based on severity of anemia) until delivery.
|
Intravenous Iron
n=36 Participants
Participants receive 510mg intravenous iron ferumoxytol, with a maximum of 2 doses based on the baseline hemoglobin level.
|
|---|---|---|
|
Median Change in Hemoglobin Value Before and After Intervention by Race / Ethnicity
Week 4 - Hispanic/Latine
|
10.30 g/dL
Interval 9.57 to 10.93
|
11.40 g/dL
Interval 11.12 to 11.55
|
|
Median Change in Hemoglobin Value Before and After Intervention by Race / Ethnicity
Change at Week 4 - Hispanic/Latine
|
-0.20 g/dL
Interval -0.4 to 0.57
|
0.75 g/dL
Interval 0.57 to 1.1
|
|
Median Change in Hemoglobin Value Before and After Intervention by Race / Ethnicity
Week 4 - Non Hispanic Asian or Pacific Islander
|
10.40 g/dL
Interval 9.9 to 11.07
|
11.45 g/dL
Interval 10.78 to 11.7
|
|
Median Change in Hemoglobin Value Before and After Intervention by Race / Ethnicity
Change at Week 4 - Non Hispanic Asian or Pacific Islander
|
0.25 g/dL
Interval 0.0 to 0.55
|
1.25 g/dL
Interval 0.67 to 1.75
|
|
Median Change in Hemoglobin Value Before and After Intervention by Race / Ethnicity
Week 4 - Non Hispanic Black or African American
|
11.00 g/dL
Interval 10.95 to 11.05
|
11.20 g/dL
Interval 11.05 to 11.85
|
|
Median Change in Hemoglobin Value Before and After Intervention by Race / Ethnicity
Change at Week 4 - Non Hispanic Black or African American
|
0.40 g/dL
Interval 0.3 to 0.5
|
1.00 g/dL
Interval 0.95 to 1.65
|
|
Median Change in Hemoglobin Value Before and After Intervention by Race / Ethnicity
Week 4 - Non Hispanic White
|
11.10 g/dL
Interval 11.0 to 11.65
|
11.55 g/dL
Interval 11.2 to 12.1
|
|
Median Change in Hemoglobin Value Before and After Intervention by Race / Ethnicity
Change at Week 4 - Non Hispanic White
|
0.75 g/dL
Interval 0.27 to 1.3
|
1.65 g/dL
Interval 0.78 to 2.2
|
|
Median Change in Hemoglobin Value Before and After Intervention by Race / Ethnicity
Week 4 - Other/Unknown
|
10.70 g/dL
Interval 10.27 to 10.9
|
12.30 g/dL
Interval 12.3 to 12.3
|
|
Median Change in Hemoglobin Value Before and After Intervention by Race / Ethnicity
Change at Week 4 - Other/Unknown
|
0.45 g/dL
Interval 0.2 to 0.65
|
1.70 g/dL
Interval 1.7 to 1.7
|
Adverse Events
Oral Iron - Weeks 1 to 4
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Intravenous Iron - Weeks 1 to 4
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Oral Iron - Weeks 5 to 8
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Intravenous Iron - Weeks 5 to 8
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oral Iron - Weeks 1 to 4
n=40 participants at risk
Adverse events occurring in the oral iron group during weeks 1 to 4
|
Intravenous Iron - Weeks 1 to 4
n=40 participants at risk
Adverse events occurring in the intravenous iron group during weeks 1 to 4
|
Oral Iron - Weeks 5 to 8
n=40 participants at risk
Adverse events occurring in the oral iron group during weeks 5 to 8
|
Intravenous Iron - Weeks 5 to 8
n=40 participants at risk
Adverse events occurring in the intravenous iron group during weeks 5 to 8
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
25.0%
10/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
15.0%
6/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
17.5%
7/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
10.0%
4/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
4/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
7.5%
3/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
5.0%
2/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
5.0%
2/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
|
Gastrointestinal disorders
Gastrointestinal symptoms not listed
|
7.5%
3/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
2.5%
1/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
0.00%
0/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
0.00%
0/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
|
Gastrointestinal disorders
Nausea/ Vomiting
|
20.0%
8/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
17.5%
7/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
7.5%
3/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
5.0%
2/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
|
Nervous system disorders
Dizziness
|
2.5%
1/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
2.5%
1/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
5.0%
2/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
2.5%
1/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
|
Nervous system disorders
Headache
|
5.0%
2/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
2.5%
1/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
0.00%
0/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
5.0%
2/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
|
Blood and lymphatic system disorders
Edema/ Swelling of limbs
|
2.5%
1/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
12.5%
5/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
0.00%
0/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
7.5%
3/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
|
Skin and subcutaneous tissue disorders
Itching
|
7.5%
3/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
0.00%
0/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
5.0%
2/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
5.0%
2/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
|
Musculoskeletal and connective tissue disorders
Body aches/ pains
|
10.0%
4/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
5.0%
2/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
5.0%
2/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
2.5%
1/40 • Up to approximately 12 weeks
Participants reported adverse events (AEs) by survey using the terms listed. The week 4 survey asked participants to report AEs occurring from weeks 1 to 4 (may have been up to week 6; primary outcome analysis period) and the week 8 survey asked participants to report AEs occurring from weeks 5 to 8 (may have been up to week 12; secondary outcome analysis period).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place