Trial Outcomes & Findings for Comparison of Oral Ferrous Sulfate to Intravenous Ferumoxytol in Antepartum Iron Deficiency Anemia (NCT NCT04253626)
NCT ID: NCT04253626
Last Updated: 2025-08-26
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
2025-08-26
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=5 Participants
|
32.0 years
n=7 Participants
|
32.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latine
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non Hispanic Asian or Pacific Islander
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non Hispanic Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non Hispanic White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/Unknown
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 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
|
10.95 g/dL
Interval 9.88 to 11.18
|
11.45 g/dL
Interval 11.13 to 12.03
|
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
|
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
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
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).
|
|
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
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).
|
|
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