Trial Outcomes & Findings for Reducing the Burden of Malaria in HIV-Infected Pregnant Women and Their HIV-Exposed Children (PROMOTE-BC2) (NCT NCT02282293)
NCT ID: NCT02282293
Last Updated: 2019-03-05
Results Overview
The primary outcome will be the prevalence of placental malaria based on placental histopathology and dichotomized into any evidence of placental infection (parasites or pigment) vs. no evidence of placental infection.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
200 participants
Primary outcome timeframe
at delivery estimated to be within 10 to 30 weeks of study entry
Results posted on
2019-03-05
Participant Flow
Participant milestones
| Measure |
TS + DP Placebo Pregnancy
Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily.
Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.
Placebo
|
Daily TS + Monthly DP Pregnancy
Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily.
Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.
Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy
Monthly dihydroartemisinin-piperaquine (DP) for infants
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
97
|
97
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
TS + DP Placebo Pregnancy
Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily.
Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.
Placebo
|
Daily TS + Monthly DP Pregnancy
Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily.
Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.
Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy
Monthly dihydroartemisinin-piperaquine (DP) for infants
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Unable to comply with study procedures
|
1
|
0
|
|
Overall Study
Moved out of study area
|
0
|
1
|
Baseline Characteristics
Reducing the Burden of Malaria in HIV-Infected Pregnant Women and Their HIV-Exposed Children (PROMOTE-BC2)
Baseline characteristics by cohort
| Measure |
TS + DP Placebo Pregnancy
n=100 Participants
Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily.
Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.
Placebo
|
Daily TS + Monthly DP Pregnancy
n=100 Participants
Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily.
Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.
Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy
Monthly dihydroartemisinin-piperaquine (DP) for infants
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.3 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
29.8 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
30.1 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
100 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Gestational age (cont)
|
19.2 weeks
STANDARD_DEVIATION 4.1 • n=5 Participants
|
19.9 weeks
STANDARD_DEVIATION 4.5 • n=7 Participants
|
19.6 weeks
STANDARD_DEVIATION 4.3 • n=5 Participants
|
|
Gestational age (cat)
12-16 wk
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Gestational age (cat)
> 16-20 wk
|
30 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Gestational age (cat)
> 20 - 24 wk
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Gestational age (cat)
> 24 - 28 wk
|
13 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Gravidity
1 pregnancy
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Gravidity
2 pregnancy
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Gravidity
>= 3 pregnancies
|
82 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Insecticide-treated bednet (ITN) ownership
|
57 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Household Wealth
Lowest Tertile
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Household Wealth
Middle Tertile
|
30 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Household Wealth
Highest Tertile
|
37 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Receiving TMP-SMX prophylaxis
|
90 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Receiving ART
|
82 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
CD4+ T-cell count, cells/mm^3
|
500 cells/mm^3
n=5 Participants
|
516 cells/mm^3
n=7 Participants
|
516 cells/mm^3
n=5 Participants
|
|
HIV load below limit of detection
|
51 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
WHO HIV disease stage
WHO Stage 1
|
93 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
WHO HIV disease stage
WHO Stage 2
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
WHO HIV disease stage
WHO Stage 3
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
WHO HIV disease stage
WHO Stage 4
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Detection of malaria parasites by LAMP
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at delivery estimated to be within 10 to 30 weeks of study entryThe primary outcome will be the prevalence of placental malaria based on placental histopathology and dichotomized into any evidence of placental infection (parasites or pigment) vs. no evidence of placental infection.
Outcome measures
| Measure |
TS + DP Placebo Pregnancy
n=96 Participants
Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily.
Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.
Placebo
|
Daily TS + Monthly DP Pregnancy
n=98 Participants
Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily.
Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.
Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy
Monthly dihydroartemisinin-piperaquine (DP) for infants
|
|---|---|---|
|
Number of Participants With Placental Malaria
|
3 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Time at risk will begin following administration of first dose of study drug to deliveryThe primary outcome will be the incidence of malaria, defined as the number of incident episodes per time at risk. Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days.
Outcome measures
| Measure |
TS + DP Placebo Pregnancy
n=100 Participants
Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily.
Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.
Placebo
|
Daily TS + Monthly DP Pregnancy
n=100 Participants
Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily.
Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.
Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy
Monthly dihydroartemisinin-piperaquine (DP) for infants
|
|---|---|---|
|
Incidence of Malaria, Pregnant Women
|
0.03 Events per person-year
|
0.00 Events per person-year
|
SECONDARY outcome
Timeframe: At deliveryPopulation: Out of all 100 enrolled women in each arm: two women in TS+Placebo arm did not have maternal blood specimens collected to analyze; One participant in Daily TS + Monthly DP pregnancy arm did not have blood slide completed for microscopy results but did have blood spot collected for LAMP analysis
Proportion of women with parasitemia detected by microscopy or LAMP at delivery
Outcome measures
| Measure |
TS + DP Placebo Pregnancy
n=98 Participants
Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily.
Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.
Placebo
|
Daily TS + Monthly DP Pregnancy
n=100 Participants
Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily.
Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.
Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy
Monthly dihydroartemisinin-piperaquine (DP) for infants
|
|---|---|---|
|
Maternal Parasitemia at Delivery by Microscopy and LAMP
Microscopy
|
0 Participants
|
1 Participants
|
|
Maternal Parasitemia at Delivery by Microscopy and LAMP
LAMP
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: At deliveryPopulation: Out of all 100 enrolled women in each arm: four women in TS+Placebo arm and two women in TS+DP arm did not have placental blood specimens collected to analyze; One participant TS+Placebo arm did not have microscopy results; Only one placental blood specimen was collected for each woman
Proportion of placental blood samples positive for malaria by microscopy or PCR
Outcome measures
| Measure |
TS + DP Placebo Pregnancy
n=96 Participants
Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily.
Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.
Placebo
|
Daily TS + Monthly DP Pregnancy
n=98 Participants
Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily.
Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.
Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy
Monthly dihydroartemisinin-piperaquine (DP) for infants
|
|---|---|---|
|
Placental Parasitemia (Number of Women With Placental Blood Samples Positive for Malaria by Microscopy or PCR)
Microscopy of placental blood
|
0 Participants
|
1 Participants
|
|
Placental Parasitemia (Number of Women With Placental Blood Samples Positive for Malaria by Microscopy or PCR)
LAMP analysis of placental blood
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Following administration of first dose of study drug to deliveryProportion of monthly routine blood samples positive by LAMP for parasites
Outcome measures
| Measure |
TS + DP Placebo Pregnancy
n=392 visits with positive blood sample
Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily.
Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.
Placebo
|
Daily TS + Monthly DP Pregnancy
n=368 visits with positive blood sample
Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily.
Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.
Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy
Monthly dihydroartemisinin-piperaquine (DP) for infants
|
|---|---|---|
|
Number of Monthly Routine Visits With Positive Blood Samples for Parasites
|
12 visits with positive blood sample
|
5 visits with positive blood sample
|
SECONDARY outcome
Timeframe: At deliveryProportion with low birth weight (\<2500 gm), spontaneous abortion (\<28 weeks), stillbirth (fetal demise ≥28 weeks), congenital anomaly, or preterm delivery (\<37 weeks)
Outcome measures
| Measure |
TS + DP Placebo Pregnancy
n=100 Participants
Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily.
Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.
Placebo
|
Daily TS + Monthly DP Pregnancy
n=100 Participants
Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily.
Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.
Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy
Monthly dihydroartemisinin-piperaquine (DP) for infants
|
|---|---|---|
|
Composite Adverse Birth Outcome (Proportion With Low Birth Weight (<2500 gm), Spontaneous Abortion (<28 Weeks), Stillbirth (Fetal Demise ≥28 Weeks), Congenital Anomaly, or Preterm Delivery (<37 Weeks)
|
15 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Following administration of first dose of study drugs to deliveryAnemia (hemoglobin less than 11g/dL) measured every 8 weeks during pregnancy
Outcome measures
| Measure |
TS + DP Placebo Pregnancy
n=206 Routine visit done every 8 weeks
Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily.
Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.
Placebo
|
Daily TS + Monthly DP Pregnancy
n=191 Routine visit done every 8 weeks
Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily.
Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.
Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy
Monthly dihydroartemisinin-piperaquine (DP) for infants
|
|---|---|---|
|
Number of Routine Visits Measured Every 8 Weeks During Pregnancy for Which the Participants Had Anemia
|
65 Routine visit done every 8 weeks
|
51 Routine visit done every 8 weeks
|
Adverse Events
TS + DP Placebo Pregnancy
Serious events: 4 serious events
Other events: 92 other events
Deaths: 0 deaths
Daily TS + Monthly DP Pregnancy
Serious events: 6 serious events
Other events: 91 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TS + DP Placebo Pregnancy
n=100 participants at risk
Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily.
Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.
Placebo
|
Daily TS + Monthly DP Pregnancy
n=100 participants at risk
Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily.
Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.
Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy
Monthly dihydroartemisinin-piperaquine (DP) for infants
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.0%
3/100 • Following administration of first study drug to 6 weeks postpartum
|
2.0%
2/100 • Following administration of first study drug to 6 weeks postpartum
|
|
Congenital, familial and genetic disorders
Congenital anomaly
|
1.0%
1/100 • Following administration of first study drug to 6 weeks postpartum
|
4.0%
4/100 • Following administration of first study drug to 6 weeks postpartum
|
Other adverse events
| Measure |
TS + DP Placebo Pregnancy
n=100 participants at risk
Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily.
Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.
Placebo
|
Daily TS + Monthly DP Pregnancy
n=100 participants at risk
Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily.
Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.
Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy
Monthly dihydroartemisinin-piperaquine (DP) for infants
|
|---|---|---|
|
General disorders
Abdominal pain
|
68.0%
68/100 • Number of events 85 • Following administration of first study drug to 6 weeks postpartum
|
63.0%
63/100 • Number of events 74 • Following administration of first study drug to 6 weeks postpartum
|
|
General disorders
Cough
|
41.0%
41/100 • Number of events 69 • Following administration of first study drug to 6 weeks postpartum
|
43.0%
43/100 • Number of events 55 • Following administration of first study drug to 6 weeks postpartum
|
|
General disorders
Headache
|
34.0%
34/100 • Number of events 39 • Following administration of first study drug to 6 weeks postpartum
|
37.0%
37/100 • Number of events 43 • Following administration of first study drug to 6 weeks postpartum
|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
40/100 • Number of events 49 • Following administration of first study drug to 6 weeks postpartum
|
38.0%
38/100 • Number of events 45 • Following administration of first study drug to 6 weeks postpartum
|
|
General disorders
Malaise
|
24.0%
24/100 • Number of events 27 • Following administration of first study drug to 6 weeks postpartum
|
21.0%
21/100 • Number of events 24 • Following administration of first study drug to 6 weeks postpartum
|
|
General disorders
Diarrhea
|
14.0%
14/100 • Number of events 17 • Following administration of first study drug to 6 weeks postpartum
|
11.0%
11/100 • Number of events 14 • Following administration of first study drug to 6 weeks postpartum
|
|
General disorders
Chills
|
9.0%
9/100 • Number of events 11 • Following administration of first study drug to 6 weeks postpartum
|
11.0%
11/100 • Number of events 11 • Following administration of first study drug to 6 weeks postpartum
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.0%
11/100 • Number of events 11 • Following administration of first study drug to 6 weeks postpartum
|
10.0%
10/100 • Number of events 11 • Following administration of first study drug to 6 weeks postpartum
|
|
General disorders
Vomiting
|
6.0%
6/100 • Number of events 7 • Following administration of first study drug to 6 weeks postpartum
|
7.0%
7/100 • Number of events 7 • Following administration of first study drug to 6 weeks postpartum
|
|
General disorders
Anorexia
|
6.0%
6/100 • Number of events 6 • Following administration of first study drug to 6 weeks postpartum
|
4.0%
4/100 • Number of events 4 • Following administration of first study drug to 6 weeks postpartum
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
0.00%
0/100 • Following administration of first study drug to 6 weeks postpartum
|
1.0%
1/100 • Number of events 1 • Following administration of first study drug to 6 weeks postpartum
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
1.0%
1/100 • Number of events 1 • Following administration of first study drug to 6 weeks postpartum
|
0.00%
0/100 • Following administration of first study drug to 6 weeks postpartum
|
|
Psychiatric disorders
Altered mental status
|
0.00%
0/100 • Following administration of first study drug to 6 weeks postpartum
|
1.0%
1/100 • Number of events 1 • Following administration of first study drug to 6 weeks postpartum
|
|
Hepatobiliary disorders
Elevated ALT level
|
0.00%
0/100 • Following administration of first study drug to 6 weeks postpartum
|
1.0%
1/100 • Number of events 1 • Following administration of first study drug to 6 weeks postpartum
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place