Trial Outcomes & Findings for Optimal Chemopreventive Regimens to Prevent Malaria and Improve Birth Outcomes in Uganda (NCT NCT04336189)
NCT ID: NCT04336189
Last Updated: 2025-11-06
Results Overview
Composite adverse birth outcome defined as the occurrence of any of the following: * Spontaneous abortion: Fetal loss at \< 28 weeks gestational age * Stillbirth: Infant born deceased at \> 28 weeks gestational age * Low Birth Weight (LBW): Live birth with birth weight \< 2500 gm * Preterm birth: Live birth at \< 37 weeks gestational age * Small-for-gestational age (SGA): Live birth with weight-for-gestational age \< 10th percentile of reference population * Neonatal death: Live birth with neonatal death within the first 28 days of life
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2757 participants
Primary outcome timeframe
Time from first dose of study drugs up to 28 days postpartum, an average of 6 months
Results posted on
2025-11-06
Participant Flow
Participant milestones
| Measure |
SP + DP placebo every 4 weeks
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
918
|
920
|
919
|
|
Overall Study
COMPLETED
|
842
|
846
|
850
|
|
Overall Study
NOT COMPLETED
|
76
|
74
|
69
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data not collected from 29 participants
Baseline characteristics by cohort
| Measure |
SP + DP placebo every 4 weeks
n=918 Participants
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=920 Participants
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=919 Participants
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
Total
n=2757 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
24.5 years
STANDARD_DEVIATION 6.2 • n=918 Participants
|
24.7 years
STANDARD_DEVIATION 6.3 • n=920 Participants
|
24.2 years
STANDARD_DEVIATION 6.0 • n=919 Participants
|
24.5 years
STANDARD_DEVIATION 6.2 • n=2757 Participants
|
|
Sex: Female, Male
Female
|
918 Participants
n=918 Participants
|
920 Participants
n=920 Participants
|
919 Participants
n=919 Participants
|
2757 Participants
n=2757 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=918 Participants
|
0 Participants
n=920 Participants
|
0 Participants
n=919 Participants
|
0 Participants
n=2757 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=918 Participants
|
0 Participants
n=920 Participants
|
0 Participants
n=919 Participants
|
0 Participants
n=2757 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=918 Participants
|
0 Participants
n=920 Participants
|
0 Participants
n=919 Participants
|
0 Participants
n=2757 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=918 Participants
|
0 Participants
n=920 Participants
|
0 Participants
n=919 Participants
|
0 Participants
n=2757 Participants
|
|
Race (NIH/OMB)
Black or African American
|
918 Participants
n=918 Participants
|
920 Participants
n=920 Participants
|
919 Participants
n=919 Participants
|
2757 Participants
n=2757 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=918 Participants
|
0 Participants
n=920 Participants
|
0 Participants
n=919 Participants
|
0 Participants
n=2757 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=918 Participants
|
0 Participants
n=920 Participants
|
0 Participants
n=919 Participants
|
0 Participants
n=2757 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=918 Participants
|
0 Participants
n=920 Participants
|
0 Participants
n=919 Participants
|
0 Participants
n=2757 Participants
|
|
Region of Enrollment
Uganda
|
918 participants
n=918 Participants
|
920 participants
n=920 Participants
|
919 participants
n=919 Participants
|
2757 participants
n=2757 Participants
|
|
Gestational age
|
15.8 weeks
STANDARD_DEVIATION 2.6 • n=918 Participants
|
15.7 weeks
STANDARD_DEVIATION 2.5 • n=920 Participants
|
16.0 weeks
STANDARD_DEVIATION 2.6 • n=919 Participants
|
15.8 weeks
STANDARD_DEVIATION 2.6 • n=2757 Participants
|
|
Gestational age categories
12-16 weeks
|
522 Participants
n=918 Participants
|
530 Participants
n=920 Participants
|
481 Participants
n=919 Participants
|
1533 Participants
n=2757 Participants
|
|
Gestational age categories
>16 weeks
|
396 Participants
n=918 Participants
|
390 Participants
n=920 Participants
|
438 Participants
n=919 Participants
|
1224 Participants
n=2757 Participants
|
|
Gravidity
Primigravidae
|
230 Participants
n=918 Participants
|
234 Participants
n=920 Participants
|
262 Participants
n=919 Participants
|
726 Participants
n=2757 Participants
|
|
Gravidity
Multigravidae
|
688 Participants
n=918 Participants
|
686 Participants
n=920 Participants
|
657 Participants
n=919 Participants
|
2031 Participants
n=2757 Participants
|
|
Bednet ownership
None
|
423 Participants
n=918 Participants
|
434 Participants
n=920 Participants
|
415 Participants
n=919 Participants
|
1272 Participants
n=2757 Participants
|
|
Bednet ownership
Untreated net
|
43 Participants
n=918 Participants
|
40 Participants
n=920 Participants
|
42 Participants
n=919 Participants
|
125 Participants
n=2757 Participants
|
|
Bednet ownership
Long-lasting insecticide-treated net
|
452 Participants
n=918 Participants
|
446 Participants
n=920 Participants
|
462 Participants
n=919 Participants
|
1360 Participants
n=2757 Participants
|
|
Household wealth index
Lowest tertile
|
308 Participants
n=908 Participants • Data not collected from 29 participants
|
294 Participants
n=909 Participants • Data not collected from 29 participants
|
295 Participants
n=911 Participants • Data not collected from 29 participants
|
897 Participants
n=2728 Participants • Data not collected from 29 participants
|
|
Household wealth index
Middle tertile
|
293 Participants
n=908 Participants • Data not collected from 29 participants
|
319 Participants
n=909 Participants • Data not collected from 29 participants
|
309 Participants
n=911 Participants • Data not collected from 29 participants
|
921 Participants
n=2728 Participants • Data not collected from 29 participants
|
|
Household wealth index
Highest tertile
|
307 Participants
n=908 Participants • Data not collected from 29 participants
|
296 Participants
n=909 Participants • Data not collected from 29 participants
|
307 Participants
n=911 Participants • Data not collected from 29 participants
|
910 Participants
n=2728 Participants • Data not collected from 29 participants
|
|
Highest level of education
None
|
44 Participants
n=918 Participants
|
31 Participants
n=920 Participants
|
36 Participants
n=919 Participants
|
111 Participants
n=2757 Participants
|
|
Highest level of education
Primary school
|
592 Participants
n=918 Participants
|
593 Participants
n=920 Participants
|
600 Participants
n=919 Participants
|
1785 Participants
n=2757 Participants
|
|
Highest level of education
Secondary school
|
263 Participants
n=918 Participants
|
276 Participants
n=920 Participants
|
264 Participants
n=919 Participants
|
803 Participants
n=2757 Participants
|
|
Highest level of education
Higher
|
19 Participants
n=918 Participants
|
20 Participants
n=920 Participants
|
19 Participants
n=919 Participants
|
58 Participants
n=2757 Participants
|
|
Weight in kg
|
57.3 kg
STANDARD_DEVIATION 9.4 • n=918 Participants
|
57.6 kg
STANDARD_DEVIATION 9.8 • n=920 Participants
|
57.1 kg
STANDARD_DEVIATION 8.9 • n=919 Participants
|
57.4 kg
STANDARD_DEVIATION 9.4 • n=2757 Participants
|
|
Height in cm
|
159 cm
STANDARD_DEVIATION 6 • n=918 Participants
|
159 cm
STANDARD_DEVIATION 7 • n=920 Participants
|
159 cm
STANDARD_DEVIATION 6 • n=919 Participants
|
159 cm
STANDARD_DEVIATION 6 • n=2757 Participants
|
|
Maternal MUAC
|
26 cm
STANDARD_DEVIATION 4 • n=918 Participants
|
26 cm
STANDARD_DEVIATION 3 • n=920 Participants
|
26 cm
STANDARD_DEVIATION 3 • n=919 Participants
|
26 cm
STANDARD_DEVIATION 3 • n=2757 Participants
|
|
Mean hemoglobin
|
11.6 g/dL
STANDARD_DEVIATION 1.3 • n=918 Participants
|
11.7 g/dL
STANDARD_DEVIATION 1.3 • n=920 Participants
|
11.5 g/dL
STANDARD_DEVIATION 1.4 • n=919 Participants
|
11.6 g/dL
STANDARD_DEVIATION 1.4 • n=2757 Participants
|
|
Prevalence of dhfr/dhps quintuple mutant markers of antifolate resistance
dhfr/dhps quintuple mutant
|
72 participants
n=72 Participants • Randomly subset of 200 participant samples with parasite density \>100/microliter
|
64 participants
n=65 Participants • Randomly subset of 200 participant samples with parasite density \>100/microliter
|
62 participants
n=63 Participants • Randomly subset of 200 participant samples with parasite density \>100/microliter
|
198 participants
n=200 Participants • Randomly subset of 200 participant samples with parasite density \>100/microliter
|
|
Prevalence of dhfr/dhps quintuple mutant markers of antifolate resistance
dhfr l164L
|
14 participants
n=72 Participants • Randomly subset of 200 participant samples with parasite density \>100/microliter
|
19 participants
n=65 Participants • Randomly subset of 200 participant samples with parasite density \>100/microliter
|
8 participants
n=63 Participants • Randomly subset of 200 participant samples with parasite density \>100/microliter
|
41 participants
n=200 Participants • Randomly subset of 200 participant samples with parasite density \>100/microliter
|
|
Prevalence of dhfr/dhps quintuple mutant markers of antifolate resistance
dhps A581G
|
1 participants
n=72 Participants • Randomly subset of 200 participant samples with parasite density \>100/microliter
|
2 participants
n=65 Participants • Randomly subset of 200 participant samples with parasite density \>100/microliter
|
1 participants
n=63 Participants • Randomly subset of 200 participant samples with parasite density \>100/microliter
|
4 participants
n=200 Participants • Randomly subset of 200 participant samples with parasite density \>100/microliter
|
|
Detection of malaria parasites by microscopy or qPCR
|
634 Participants
n=918 Participants
|
637 Participants
n=920 Participants
|
657 Participants
n=919 Participants
|
1928 Participants
n=2757 Participants
|
PRIMARY outcome
Timeframe: Time from first dose of study drugs up to 28 days postpartum, an average of 6 monthsComposite adverse birth outcome defined as the occurrence of any of the following: * Spontaneous abortion: Fetal loss at \< 28 weeks gestational age * Stillbirth: Infant born deceased at \> 28 weeks gestational age * Low Birth Weight (LBW): Live birth with birth weight \< 2500 gm * Preterm birth: Live birth at \< 37 weeks gestational age * Small-for-gestational age (SGA): Live birth with weight-for-gestational age \< 10th percentile of reference population * Neonatal death: Live birth with neonatal death within the first 28 days of life
Outcome measures
| Measure |
SP + DP placebo every 4 weeks
n=842 Participants
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=846 Participants
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=850 Participants
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Risk of Having a Composite Adverse Birth Outcome
|
222 Participants
|
261 Participants
|
255 Participants
|
PRIMARY outcome
Timeframe: Time from first dose of study drugs up to 28 days postpartum, an average of 6 monthsSAEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Outcome measures
| Measure |
SP + DP placebo every 4 weeks
n=432 person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=434 person years
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=433 person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Incidence of Serious Adverse Events (SAE) Per Time at Risk
|
0.06 Events per person-years
|
0.06 Events per person-years
|
0.06 Events per person-years
|
PRIMARY outcome
Timeframe: Time from first dose of study drugs up to 28 days postpartum, an average of 6 monthsGrade 3 and 4 AEs or SAEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Outcome measures
| Measure |
SP + DP placebo every 4 weeks
n=432 Person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=434 Person years
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=433 Person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Incidence of Any Grade 3 or 4 or Serious Adverse Events Per Time at Risk
|
0.23 Events per person-year
|
0.19 Events per person-year
|
0.21 Events per person-year
|
SECONDARY outcome
Timeframe: Time of deliverySpontaneous abortion defined as fetal loss at \< 28 weeks gestational age
Outcome measures
| Measure |
SP + DP placebo every 4 weeks
n=842 Participants
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=846 Participants
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=850 Participants
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Number of Participants With Spontaneous Abortion
|
12 Participants
|
16 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 monthsGrade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Outcome measures
| Measure |
SP + DP placebo every 4 weeks
n=432 Person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=434 Person years
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=433 Person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Incidence of Anemia Adverse Event Per Time at Risk
|
53 Events per person-years
|
28 Events per person-years
|
44 Events per person-years
|
SECONDARY outcome
Timeframe: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 monthsGrade 3-4 AEs possibly or definitely related to study drug defined by the July 2017 NIH DAIDS Toxicity Tables
Outcome measures
| Measure |
SP + DP placebo every 4 weeks
n=432 Person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=434 Person years
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=433 Person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Incidence of Grade 3-4 AEs Possibly Related to Study Drugs
|
50 Events per person-years
|
29 Events per person-years
|
41 Events per person-years
|
SECONDARY outcome
Timeframe: At the time of deliveryDetection of malaria parasites or pigment by histopathology
Outcome measures
| Measure |
SP + DP placebo every 4 weeks
n=776 Participants
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=795 Participants
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=784 Participants
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Risk of Placental Malaria
|
472 Participants
|
324 Participants
|
393 Participants
|
SECONDARY outcome
Timeframe: Day study drugs first given until delivery, an average of 6 monthsEpisodes of symptomatic malaria (incidence per person year at risk following initiation of study drugs)
Outcome measures
| Measure |
SP + DP placebo every 4 weeks
n=367 Person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=369 Person years
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=367 Person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Incidence of Malaria During Pregnancy
|
1.15 Events per person-years
|
0.02 Events per person-years
|
0.04 Events per person-years
|
SECONDARY outcome
Timeframe: Day study drugs first given until delivery, an average of 6 monthsProportion of routine samples with asexual parasites detected by microscopy
Outcome measures
| Measure |
SP + DP placebo every 4 weeks
n=4350 Routine visits
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=4348 Routine visits
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=4354 Routine visits
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Microscopic Parasitemia During Pregnancy
|
771 Routine visits with parasitemia
|
25 Routine visits with parasitemia
|
60 Routine visits with parasitemia
|
SECONDARY outcome
Timeframe: Day study drugs are first given until deliveryProportion of routine hemoglobin measurements \< 11 g/dL
Outcome measures
| Measure |
SP + DP placebo every 4 weeks
n=2232 Routine visits
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=2252 Routine visits
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=2229 Routine visits
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Prevalence of Anemia During Pregnancy
|
965 Routine visits with anemia
|
827 Routine visits with anemia
|
880 Routine visits with anemia
|
SECONDARY outcome
Timeframe: Time of deliveryStillbirth defined as infant born deceased at \> 28 weeks gestational age
Outcome measures
| Measure |
SP + DP placebo every 4 weeks
n=830 Participants
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=830 Participants
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=837 Participants
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Stillbirth
|
15 Participants
|
16 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Time of deliveryLow birth weight defined as live birth with birth weight \< 2500 gm
Outcome measures
| Measure |
SP + DP placebo every 4 weeks
n=815 Participants
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=812 Participants
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=830 Participants
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Low Birth Rate
|
47 Participants
|
59 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: Time of deliveryPreterm delivery defined as live birth at \< 37 weeks gestational age
Outcome measures
| Measure |
SP + DP placebo every 4 weeks
n=815 Participants
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=814 Participants
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=830 Participants
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Preterm Delivery
|
48 Participants
|
25 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: Time of deliverySmall-for-gestational age defined as live birth with weight-for-gestational age \< 10th percentile of reference population
Outcome measures
| Measure |
SP + DP placebo every 4 weeks
n=815 Participants
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=812 Participants
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=830 Participants
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Small-for-gestational Age
|
152 Participants
|
206 Participants
|
194 Participants
|
SECONDARY outcome
Timeframe: Time of deliveryNeonatal death defined as live birth with neonatal death within the first 28 days of life
Outcome measures
| Measure |
SP + DP placebo every 4 weeks
n=815 Participants
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=814 Participants
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=830 Participants
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Neonatal Death
|
4 Participants
|
5 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Day study drugs first given until delivery, an average of 6 monthsProportion of routine samples with asexual parasites detected by microscopy or qPCR
Outcome measures
| Measure |
SP + DP placebo every 4 weeks
n=4350 routine visits
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=4348 routine visits
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=4354 routine visits
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Microscopic or Sub-microscopic Parasitemia During Pregnancy
|
2099 routine visits with parasitemia
|
551 routine visits with parasitemia
|
60 routine visits with parasitemia
|
SECONDARY outcome
Timeframe: Day study drugs are first given until delivery, an average of 6 monthsProportion of routine hemoglobin measurements \< 8 g/dL
Outcome measures
| Measure |
SP + DP placebo every 4 weeks
n=2232 Routine visits
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=2252 Routine visits
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=2229 Routine visits
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Prevalence of Severe Anemia During Pregnancy
|
29 Routine visits with severe anemia
|
9 Routine visits with severe anemia
|
12 Routine visits with severe anemia
|
SECONDARY outcome
Timeframe: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 monthsGrade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Outcome measures
| Measure |
SP + DP placebo every 4 weeks
n=432 person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=434 person years
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=433 person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Incidence of Stillbirth Adverse Event Per Time at Risk
|
15 Events per person-year
|
16 Events per person-year
|
7 Events per person-year
|
SECONDARY outcome
Timeframe: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 monthsGrade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Outcome measures
| Measure |
SP + DP placebo every 4 weeks
n=432 person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=434 person years
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=433 person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Incidence of Congenital Anomaly Adverse Event Per Time at Risk
|
4 Events per person-year
|
13 Events per person-year
|
10 Events per person-year
|
SECONDARY outcome
Timeframe: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 monthsGrade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Outcome measures
| Measure |
SP + DP placebo every 4 weeks
n=432 person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=434 person years
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=433 person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Incidence of Neutropenia Adverse Event Per Time at Risk
|
5 Events per person-year
|
10 Events per person-year
|
7 Events per person-year
|
SECONDARY outcome
Timeframe: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 monthsGrade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Outcome measures
| Measure |
SP + DP placebo every 4 weeks
n=432 person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=434 person years
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=433 person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Incidence of Proteinuria Adverse Event Per Time at Risk
|
3 Events per person-years
|
4 Events per person-years
|
8 Events per person-years
|
SECONDARY outcome
Timeframe: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 monthsGrade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Outcome measures
| Measure |
SP + DP placebo every 4 weeks
n=432 person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=434 person years
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=433 person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Incidence of Thrombocytopenia Adverse Event Per Time at Risk
|
7 Events per person-years
|
1 Events per person-years
|
2 Events per person-years
|
SECONDARY outcome
Timeframe: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 monthsGrade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Outcome measures
| Measure |
SP + DP placebo every 4 weeks
n=432 person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=434 person years
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=433 person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Incidence of Postpartum Hemorrhage Adverse Event Per Time at Risk
|
2 Events per person-years
|
3 Events per person-years
|
2 Events per person-years
|
SECONDARY outcome
Timeframe: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 monthsGrade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Outcome measures
| Measure |
SP + DP placebo every 4 weeks
n=432 person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=434 person years
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=433 person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Incidence of Pre-eclampsia Adverse Event Per Time at Risk
|
3 Events per person-years
|
0 Events per person-years
|
2 Events per person-years
|
SECONDARY outcome
Timeframe: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 monthsGrade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Outcome measures
| Measure |
SP + DP placebo every 4 weeks
n=432 person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=434 person years
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=433 person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Incidence of Preterm Birth <28 Gestational Age Adverse Event Per Time at Risk
|
0 Events per person-years
|
0 Events per person-years
|
3 Events per person-years
|
SECONDARY outcome
Timeframe: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 monthsGrade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Outcome measures
| Measure |
SP + DP placebo every 4 weeks
n=432 person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=434 person years
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=433 person years
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Incidence of Elevated Temperature Adverse Event Per Time at Risk
|
2 Events per person-year
|
1 Events per person-year
|
0 Events per person-year
|
Adverse Events
SP + DP placebo every 4 weeks
Serious events: 25 serious events
Other events: 896 other events
Deaths: 1 deaths
DP + SP placebo every 4 weeks
Serious events: 26 serious events
Other events: 902 other events
Deaths: 2 deaths
SP + DP given every 4 weeks
Serious events: 27 serious events
Other events: 908 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SP + DP placebo every 4 weeks
n=896 participants at risk
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=902 participants at risk
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=908 participants at risk
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/896 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.00%
0/902 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.11%
1/908 • Number of events 1 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
Blood and lymphatic system disorders
Anemia
|
0.89%
8/896 • Number of events 8 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.22%
2/902 • Number of events 2 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.66%
6/908 • Number of events 6 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.33%
3/896 • Number of events 3 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.44%
4/902 • Number of events 4 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.44%
4/908 • Number of events 4 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
Pregnancy, puerperium and perinatal conditions
Post-partum hemmorrha
|
0.22%
2/896 • Number of events 2 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.33%
3/902 • Number of events 3 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.22%
2/908 • Number of events 2 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
Infections and infestations
Septicemia
|
0.11%
1/896 • Number of events 1 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.00%
0/902 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.00%
0/908 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
Pregnancy, puerperium and perinatal conditions
Premature rupture of membranes
|
0.11%
1/896 • Number of events 1 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.00%
0/902 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.11%
1/908 • Number of events 1 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
Pregnancy, puerperium and perinatal conditions
Abruptio placenta
|
0.11%
1/896 • Number of events 1 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.00%
0/902 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.11%
1/908 • Number of events 1 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
Pregnancy, puerperium and perinatal conditions
Congenital anomoly
|
0.45%
4/896 • Number of events 4 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
1.4%
13/902 • Number of events 13 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
1.1%
10/908 • Number of events 10 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/896 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.11%
1/902 • Number of events 1 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.00%
0/908 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.33%
3/896 • Number of events 3 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.00%
0/902 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.22%
2/908 • Number of events 2 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
Nervous system disorders
Transverse myelitis
|
0.00%
0/896 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.11%
1/902 • Number of events 1 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.00%
0/908 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
Infections and infestations
Puerperal sepsis
|
0.22%
2/896 • Number of events 2 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.00%
0/902 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.00%
0/908 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
Infections and infestations
COVID-19
|
0.00%
0/896 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.11%
1/902 • Number of events 1 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.00%
0/908 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
Injury, poisoning and procedural complications
Deep laceration
|
0.00%
0/896 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.11%
1/902 • Number of events 1 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.00%
0/908 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
Other adverse events
| Measure |
SP + DP placebo every 4 weeks
n=896 participants at risk
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
|
DP + SP placebo every 4 weeks
n=902 participants at risk
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
SP + DP given every 4 weeks
n=908 participants at risk
Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
|
|---|---|---|---|
|
Gastrointestinal disorders
Epigastric pain
|
6.2%
56/896 • Number of events 83 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
8.0%
72/902 • Number of events 79 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
6.6%
60/908 • Number of events 62 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
45/896 • Number of events 45 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
2.9%
26/902 • Number of events 26 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
4.2%
38/908 • Number of events 38 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
1.7%
15/896 • Number of events 15 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
1.8%
16/902 • Number of events 16 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.77%
7/908 • Number of events 7 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.22%
2/896 • Number of events 2 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.67%
6/902 • Number of events 6 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.33%
3/908 • Number of events 3 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
Renal and urinary disorders
Proteinuria
|
0.33%
3/896 • Number of events 3 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.44%
4/902 • Number of events 4 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.88%
8/908 • Number of events 8 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
Renal and urinary disorders
Dysuria
|
29.8%
267/896 • Number of events 379 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
2.8%
25/902 • Number of events 324 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
26.4%
240/908 • Number of events 324 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
17.3%
155/896 • Number of events 189 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
15.3%
138/902 • Number of events 164 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
15.5%
141/908 • Number of events 167 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
Gastrointestinal disorders
Diarrhea
|
15.2%
136/896 • Number of events 174 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
13.6%
123/902 • Number of events 143 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
12.6%
114/908 • Number of events 140 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
General disorders
Fatigue
|
9.2%
82/896 • Number of events 101 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
6.9%
62/902 • Number of events 79 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
5.4%
49/908 • Number of events 56 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
General disorders
Chills
|
7.5%
67/896 • Number of events 67 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
7.0%
63/902 • Number of events 90 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
6.1%
55/908 • Number of events 66 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
Gastrointestinal disorders
Abdominal pain
|
69.2%
620/896 • Number of events 1532 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
68.8%
621/902 • Number of events 1431 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
64.3%
584/908 • Number of events 1364 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
58.7%
526/896 • Number of events 1064 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
59.9%
540/902 • Number of events 1130 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
58.0%
527/908 • Number of events 1004 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
Nervous system disorders
Headache
|
56.9%
510/896 • Number of events 947 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
52.9%
477/902 • Number of events 865 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
48.0%
436/908 • Number of events 769 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
Renal and urinary disorders
Thrombocytopenia
|
0.78%
7/896 • Number of events 7 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.11%
1/902 • Number of events 1 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.22%
2/908 • Number of events 2 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
Pregnancy, puerperium and perinatal conditions
Preterm birth
|
0.00%
0/896 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.00%
0/902 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.33%
3/908 • Number of events 3 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
|
General disorders
Elevated temperature
|
0.22%
2/896 • Number of events 2 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.11%
1/902 • Number of events 1 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
0.00%
0/908 • Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place