Trial Outcomes & Findings for Evaluate Parasitological Clearance Rates And Pharmacokinetics Of The Combination Of Azithromycin And Chloroquine In Asymptomatic Pregnant Women With Falciparum Parasitemia In Africa (NCT NCT01103713)
NCT ID: NCT01103713
Last Updated: 2015-01-26
Results Overview
The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
168 participants
Primary outcome timeframe
Day 28
Results posted on
2015-01-26
Participant Flow
Participants were enrolled at 5 active sites in 5 countries: Benin (site 1012), Kenya (site 1004), Malawi (site 1015), Tanzania (site 1008), and Uganda (site 1013). The enrollment of the first participant took place on 07 March 2011 and the last participant last visit was on 25 October 2013.
A total of 404 participants were screened and 168 participants were assigned to study drug, enrolled and treated. Of the 168 participants, two participants were excluded from the pharmacokinetic (PK) analysis, modified intent-to-treat (MITT), intent-to-treat (ITT) and per protocol (PP) populations due to informed consent protocol deviations.
Participant milestones
| Measure |
Azithromycin (AZ)/Chloroquine (CQ)
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
|
|---|---|
|
Overall Study
STARTED
|
168
|
|
Overall Study
COMPLETED
|
155
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Azithromycin (AZ)/Chloroquine (CQ)
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Study terminated by sponsor
|
2
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
Evaluate Parasitological Clearance Rates And Pharmacokinetics Of The Combination Of Azithromycin And Chloroquine In Asymptomatic Pregnant Women With Falciparum Parasitemia In Africa
Baseline characteristics by cohort
| Measure |
Azithromycin (AZ)/Chloroquine (CQ)
n=168 Participants
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
|
|---|---|
|
Age, Customized
<16 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
16-17 years
|
41 Participants
n=5 Participants
|
|
Age, Customized
18-25 years
|
125 Participants
n=5 Participants
|
|
Age, Customized
26-30 years
|
1 Participants
n=5 Participants
|
|
Age, Customized
31-35 years
|
1 Participants
n=5 Participants
|
|
Age, Customized
>35 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
168 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process.
The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.
Outcome measures
| Measure |
Azithromycin (AZ)/Chloroquine (CQ)
n=163 Participants
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
|
|---|---|
|
Percentage of Participants With Parasitologic Response (Polymerase Chain Reaction (PCR) Corrected) at Day 28 Post First Dose of Study Medication
|
99.35 Percentage of participants
Interval 97.76 to 100.0
|
PRIMARY outcome
Timeframe: Day 28Population: PP population was used. PP is a subset of MITT population who had received all 3 days of study medication. Two participants were excluded because they had protocol deviations regarding the informed consent process.
The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.
Outcome measures
| Measure |
Azithromycin (AZ)/Chloroquine (CQ)
n=158 Participants
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
|
|---|---|
|
Percentage of Participants With Parasitologic Response (PCR Corrected) at Day 28 Post First Dose of Study Medication
|
99.35 Percentage of participants
Interval 97.76 to 100.0
|
SECONDARY outcome
Timeframe: Days 7, 14, 21, 35, and 42Population: MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process.
The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.
Outcome measures
| Measure |
Azithromycin (AZ)/Chloroquine (CQ)
n=163 Participants
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
|
|---|---|
|
Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 Post First Dose of Study Medication
Day 7 (n=156)
|
100 Percentage of participants
Interval 97.66 to 100.0
|
|
Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 Post First Dose of Study Medication
Day 14 (n=154)
|
100 Percentage of participants
Interval 97.63 to 100.0
|
|
Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 Post First Dose of Study Medication
Day 21 (n=154)
|
100 Percentage of participants
Interval 97.63 to 100.0
|
|
Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 Post First Dose of Study Medication
Day 35 (n=148)
|
96.65 Percentage of participants
Interval 93.42 to 99.87
|
|
Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 Post First Dose of Study Medication
Day 42 (n=138)
|
95.19 Percentage of participants
Interval 91.35 to 99.03
|
SECONDARY outcome
Timeframe: Days 7, 14, 21, 35, and 42Population: PP population was used. PP is a subset of MITT population who had received all 3 days of study medication. Two participants were excluded because they had protocol deviations regarding the informed consent process.
The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.
Outcome measures
| Measure |
Azithromycin (AZ)/Chloroquine (CQ)
n=158 Participants
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
|
|---|---|
|
Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 , Post First Dose of Study Medication
Day 7 (n=156)
|
100.00 Percentage of participants
Interval 97.66 to 100.0
|
|
Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 , Post First Dose of Study Medication
Day 14 (n=154)
|
100.00 Percentage of participants
Interval 97.63 to 100.0
|
|
Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 , Post First Dose of Study Medication
Day 21 (n=154)
|
100.00 Percentage of participants
Interval 97.63 to 100.0
|
|
Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 , Post First Dose of Study Medication
Day 35 (n=148)
|
96.65 Percentage of participants
Interval 93.42 to 99.87
|
|
Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 , Post First Dose of Study Medication
Day 42 (n=138)
|
95.19 Percentage of participants
Interval 91.35 to 99.03
|
SECONDARY outcome
Timeframe: Days 7, 14, 21, 28, 35, and 42Population: ITT population was used. ITT is defined as all participants who received at least one dose of study medication and who had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two participants were excluded because they had protocol deviations regarding the informed consent process.
The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.
Outcome measures
| Measure |
Azithromycin (AZ)/Chloroquine (CQ)
n=165 Participants
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
|
|---|---|
|
Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 7 (n=158)
|
100.00 Percentage of participants
Interval 97.69 to 100.0
|
|
Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 14 (n=156)
|
100.00 Percentage of participants
Interval 97.66 to 100.0
|
|
Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 21 (n=156)
|
100.00 Percentage of participants
Interval 97.66 to 100.0
|
|
Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 28 (n=156)
|
99.36 Percentage of participants
Interval 97.79 to 100.0
|
|
Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 35 (n=150)
|
96.69 Percentage of participants
Interval 93.51 to 99.88
|
|
Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 42 (n=140)
|
95.26 Percentage of participants
Interval 91.47 to 99.05
|
SECONDARY outcome
Timeframe: Days 7, 14, 21, 28, 35, and 42Population: MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process.
The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR uncorrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR uncorrected) through the day of consideration, otherwise she is a parasitological failure.
Outcome measures
| Measure |
Azithromycin (AZ)/Chloroquine (CQ)
n=163 Participants
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
|
|---|---|
|
Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 7 (n=156)
|
100.00 Percentage of participants
Interval 97.66 to 100.0
|
|
Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 14 (n=154)
|
100.00 Percentage of participants
Interval 97.63 to 100.0
|
|
Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 21 (n=154)
|
100.00 Percentage of participants
Interval 97.63 to 100.0
|
|
Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 28 (n=154)
|
95.45 Percentage of participants
Interval 91.84 to 99.07
|
|
Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 35 (n=154)
|
87.66 Percentage of participants
Interval 82.14 to 93.18
|
|
Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 42 (n=152)
|
78.43 Percentage of participants
Interval 71.59 to 85.28
|
SECONDARY outcome
Timeframe: Days 7, 14, 21, 28, 35, and 42Population: PP population was used. PP is a subset of MITT population who received all 3 days of study medication. Two participants were excluded because they had protocol deviations regarding the informed consent process.
The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR uncorrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR uncorrected) through the day of consideration, otherwise she is a parasitological failure.
Outcome measures
| Measure |
Azithromycin (AZ)/Chloroquine (CQ)
n=158 Participants
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
|
|---|---|
|
Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 7 (n=156)
|
100.00 Percentage of participants
Interval 97.66 to 100.0
|
|
Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 14 (n=154)
|
100.00 Percentage of participants
Interval 97.63 to 100.0
|
|
Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 21 (n=154)
|
100.00 Percentage of participants
Interval 97.63 to 100.0
|
|
Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 28 (n=154)
|
95.45 Percentage of participants
Interval 91.84 to 99.07
|
|
Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 35 (n=154)
|
87.66 Percentage of participants
Interval 82.14 to 93.18
|
|
Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 42 (n=152)
|
78.43 Percentage of participants
Interval 71.59 to 85.28
|
SECONDARY outcome
Timeframe: Days 7, 14, 21, 28, 35, and 42Population: ITT population was used. ITT is defined as all participants who received at least one dose of study medication and had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two participants were excluded because they had protocol deviations regarding the informed consent process.
The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR uncorrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR uncorrected) through the day of consideration, otherwise she is a parasitological failure.
Outcome measures
| Measure |
Azithromycin (AZ)/Chloroquine (CQ)
n=165 Participants
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
|
|---|---|
|
Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 7 (n=158)
|
100.00 Percentage of participants
Interval 97.69 to 100.0
|
|
Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 14 (n=156)
|
100.00 Percentage of participants
Interval 97.66 to 100.0
|
|
Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 21 (n=156)
|
100.00 Percentage of participants
Interval 97.66 to 100.0
|
|
Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 28 (n=156)
|
95.51 Percentage of participants
Interval 91.94 to 99.08
|
|
Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 35 (n=156)
|
87.82 Percentage of participants
Interval 82.37 to 93.27
|
|
Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 42 (n=154)
|
78.71 Percentage of participants
Interval 71.94 to 85.48
|
SECONDARY outcome
Timeframe: Days 7, 14, 21, 28, 35, and 42Population: ITT population was used. ITT is defined as all participants who received at least one dose of study medication and had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two participants were excluded because they had protocol deviations regarding the informed consent process.
Parasite counts (actual counts per microliter of blood) was measured at various time points.
Outcome measures
| Measure |
Azithromycin (AZ)/Chloroquine (CQ)
n=165 Participants
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
|
|---|---|
|
Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 7 (n=155)
|
0.00 Parasite count per microliter
Standard Error 0.00
|
|
Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 14 (n=154)
|
0.00 Parasite count per microliter
Standard Error 0.00
|
|
Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 21 (n=156)
|
0.00 Parasite count per microliter
Standard Error 0.00
|
|
Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 28 (n=156)
|
216.91 Parasite count per microliter
Standard Error 110.04
|
|
Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 35 (n=156)
|
555.36 Parasite count per microliter
Standard Error 246.77
|
|
Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 42 (n=155)
|
907.88 Parasite count per microliter
Standard Error 470.82
|
SECONDARY outcome
Timeframe: Days 7, 14, 21, 28, 35, and 42Population: MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process.
Parasite counts (actual counts per microliter of blood) was measured at various time points.
Outcome measures
| Measure |
Azithromycin (AZ)/Chloroquine (CQ)
n=163 Participants
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
|
|---|---|
|
Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 7 (n=153)
|
0.00 Parasite count per microliter
Standard Error 0.00
|
|
Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 14 (n=152)
|
0.00 Parasite count per microliter
Standard Error 0.00
|
|
Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 21 (n=154)
|
0.00 Parasite count per microliter
Standard Error 0.00
|
|
Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 28 (n=154)
|
219.73 Parasite count per microliter
Standard Error 111.46
|
|
Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 35 (n=154)
|
562.57 Parasite count per microliter
Standard Error 249.94
|
|
Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 42 (n=153)
|
919.75 Parasite count per microliter
Standard Error 476.92
|
SECONDARY outcome
Timeframe: Days 7, 14, 21, 28, 35, and 42Population: PP population was used. PP is a subset of MITT population who received all 3 days of study medication. Two participants were excluded because they had protocol deviations regarding the informed consent process.
Parasite counts (actual counts per microliter of blood) was measured at various time points.
Outcome measures
| Measure |
Azithromycin (AZ)/Chloroquine (CQ)
n=158 Participants
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
|
|---|---|
|
Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 7 (n=153)
|
0.00 Parasite count per microliter
Standard Error 0.00
|
|
Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 14 (n=152)
|
0.00 Parasite count per microliter
Standard Error 0.00
|
|
Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 21 (n=154)
|
0.00 Parasite count per microliter
Standard Error 0.00
|
|
Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 28 (n=154)
|
219.73 Parasite count per microliter
Standard Error 111.46
|
|
Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 35 (n=154)
|
562.57 Parasite count per microliter
Standard Error 249.94
|
|
Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication
Day 42 (n=153)
|
919.75 Parasite count per microliter
Standard Error 476.92
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Following delivery or pregnancy terminationPopulation: The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 160 participants only.
All participants were followed up for exposure-in-utero (EIU) safety assessments following delivery or termination of pregnancy.
Outcome measures
| Measure |
Azithromycin (AZ)/Chloroquine (CQ)
n=160 Participants
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
|
|---|---|
|
Summary of Pregnancy Outcome: Location of Delivery
Medical facility
|
130 Participants
|
|
Summary of Pregnancy Outcome: Location of Delivery
Home
|
27 Participants
|
|
Summary of Pregnancy Outcome: Location of Delivery
Other (Not specified)
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Following delivery or pregnancy terminationPopulation: The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 160 participants only.
All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.
Outcome measures
| Measure |
Azithromycin (AZ)/Chloroquine (CQ)
n=160 Participants
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
|
|---|---|
|
Summary of Pregnancy Outcome: Mode of Delivery
Vaginal
|
145 Participants
|
|
Summary of Pregnancy Outcome: Mode of Delivery
Cesarean section
|
15 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Following delivery or pregnancy terminationPopulation: The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 159 participants only.
All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.
Outcome measures
| Measure |
Azithromycin (AZ)/Chloroquine (CQ)
n=159 Participants
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
|
|---|---|
|
Summary of Pregnancy Outcome: Delivery Assisted by Trained Obstetric Personnel?
Yes
|
132 Participants
|
|
Summary of Pregnancy Outcome: Delivery Assisted by Trained Obstetric Personnel?
No
|
27 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Following delivery or pregnancy terminationPopulation: The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 158 participants only.
All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.
Outcome measures
| Measure |
Azithromycin (AZ)/Chloroquine (CQ)
n=158 Participants
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
|
|---|---|
|
Summary of Pregnancy Outcome: Labor Induced?
Yes
|
3 Participants
|
|
Summary of Pregnancy Outcome: Labor Induced?
No
|
155 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Following delivery or pregnancy terminationPopulation: The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 159 participants only.
All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.
Outcome measures
| Measure |
Azithromycin (AZ)/Chloroquine (CQ)
n=159 Participants
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
|
|---|---|
|
Summary of Pregnancy Outcome: Complications During Delivery?
Yes
|
42 Participants
|
|
Summary of Pregnancy Outcome: Complications During Delivery?
No
|
117 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Following delivery or pregnancy terminationPopulation: The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 160 participants only.
All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.
Outcome measures
| Measure |
Azithromycin (AZ)/Chloroquine (CQ)
n=160 Participants
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
|
|---|---|
|
Summary of Pregnancy Outcome: Outcome of Birth
Full term live birth
|
151 Participants
|
|
Summary of Pregnancy Outcome: Outcome of Birth
Premature birth
|
6 Participants
|
|
Summary of Pregnancy Outcome: Outcome of Birth
Stillbirth
|
3 Participants
|
|
Summary of Pregnancy Outcome: Outcome of Birth
Spontaneous abortion
|
0 Participants
|
|
Summary of Pregnancy Outcome: Outcome of Birth
Induced/elective abortion
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Days 1, 2, 7, 14, 21, 28, 35, and 42Population: ITT is defined as all participants who received at least one dose of study medication and who had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two participants were excluded because they had protocol deviations regarding the informed consent process.
Oral temp was taken by the fieldworker through Day 42.
Outcome measures
| Measure |
Azithromycin (AZ)/Chloroquine (CQ)
n=168 Participants
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
|
|---|---|
|
Incidence of Fever Based on Oral Temperature
Baseline (n=165)
|
0 Participants
|
|
Incidence of Fever Based on Oral Temperature
Day 1 (n=161)
|
0 Participants
|
|
Incidence of Fever Based on Oral Temperature
Day 2 (n=160)
|
0 Participants
|
|
Incidence of Fever Based on Oral Temperature
Day 7 (n=156)
|
0 Participants
|
|
Incidence of Fever Based on Oral Temperature
Day 14 (n=155)
|
0 Participants
|
|
Incidence of Fever Based on Oral Temperature
Day 21 (n=155)
|
0 Participants
|
|
Incidence of Fever Based on Oral Temperature
Day 28 (n=156)
|
0 Participants
|
|
Incidence of Fever Based on Oral Temperature
Day 35 (n=156)
|
0 Participants
|
|
Incidence of Fever Based on Oral Temperature
Day 42 (n=155)
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 42Population: The safety analysis set consists of participants who received at least one dose of study medication.
Abnormal hemoglobin level on Day 42 was measured. The hemoglobin levels were measured with HemoCueTM, via finger stick or peripheral blood collection. The reference range was 10-16g/dL. Any value \<0.8 times lower limit of normal was considered clinically significant.
Outcome measures
| Measure |
Azithromycin (AZ)/Chloroquine (CQ)
n=168 Participants
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
|
|---|---|
|
Summary of Hemoglobin Concentration: Abnormal Hemoglobin Level
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), and 336 (Day 14) hours post the first dose. Note: Assuming "hour not specified" as 0 hours on Day 7 and Day 14 for planned time post first dose calculation.Population: Analyses population included all participants who received at least one dose of study medication and had at least one blood sample collected for PK analysis.
AZ concentrations in the serum was determined at specified time points as PK endpoints
Outcome measures
| Measure |
Azithromycin (AZ)/Chloroquine (CQ)
n=166 Participants
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
|
|---|---|
|
Summary of Serum Azithromycin Concentration Versus Time
Hour 0 (Day 0) (n=161)
|
NA ng/ml
Standard Deviation NA
Summary statistics have been calculated by setting concentration values below the low limit of quantification to zero.
|
|
Summary of Serum Azithromycin Concentration Versus Time
Hour 48 (Day 2) (n=158)
|
194.145 ng/ml
Standard Deviation 63.76829
|
|
Summary of Serum Azithromycin Concentration Versus Time
Hour 50 (Day 2) (n=147)
|
994.463 ng/ml
Standard Deviation 552.23738
|
|
Summary of Serum Azithromycin Concentration Versus Time
Hour 56 (Day 2) (n=159)
|
707.682 ng/ml
Standard Deviation 326.72379
|
|
Summary of Serum Azithromycin Concentration Versus Time
Hour 168 (Day 7) (n=155)
|
54.444 ng/ml
Standard Deviation 24.34615
|
|
Summary of Serum Azithromycin Concentration Versus Time
Hour 336 (Day 14) (n=153)
|
20.307 ng/ml
Standard Deviation 31.57879
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), 336 (Day 14), 504 (Day 21) and 672 (Day 28) post first dose. Note: Assuming "hour not specified" as 0 hours on Days 7, 14, 21 and 28 for planned time post first dose calculation.Population: Analyses population included all participants who received at least one dose of study medication and had at least one blood sample collected for PK analysis.
CQ concentrations in the plasma were determined at specified time points as PK endpoints
Outcome measures
| Measure |
Azithromycin (AZ)/Chloroquine (CQ)
n=166 Participants
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
|
|---|---|
|
Summary of Plasma Chloroquine Concentration Versus Time
Hour 0 (Day 0) (n=160)
|
NA ng/ml
Standard Deviation NA
Summary statistics have been calculated by setting concentration values below the low limit of quantification to zero.
|
|
Summary of Plasma Chloroquine Concentration Versus Time
Hour 48 (Day 2) (n=158)
|
305.827 ng/ml
Standard Deviation 129.02771
|
|
Summary of Plasma Chloroquine Concentration Versus Time
Hour 50 (Day 2) (n=147)
|
621.134 ng/ml
Standard Deviation 329.92731
|
|
Summary of Plasma Chloroquine Concentration Versus Time
Hour 56 (Day 2) (n=159)
|
640.679 ng/ml
Standard Deviation 297.97628
|
|
Summary of Plasma Chloroquine Concentration Versus Time
Hour 168 (Day 7) (n=155)
|
129.835 ng/ml
Standard Deviation 92.19161
|
|
Summary of Plasma Chloroquine Concentration Versus Time
Hour 336 (Day 14) (n=154)
|
43.119 ng/ml
Standard Deviation 44.97312
|
|
Summary of Plasma Chloroquine Concentration Versus Time
Hour 504 (Day 21) (n=156)
|
22.382 ng/ml
Standard Deviation 46.83029
|
|
Summary of Plasma Chloroquine Concentration Versus Time
Hour 672 (Day 28) (n=156)
|
12.721 ng/ml
Standard Deviation 29.05380
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), 336 (Day 14), 504 (Day 21) and 672 (Day 28) post first dose. Note: Assuming "hour not specified" as 0 hours on Days 7, 14, 21 and 28 for planned time post first dose calculation.Population: Analyses population included all participants who received at least one dose of study medication and had at least one blood sample collected for PK analysis.
CQ concentrations in the plasma were determined at specified time points as PK endpoints
Outcome measures
| Measure |
Azithromycin (AZ)/Chloroquine (CQ)
n=166 Participants
Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
|
|---|---|
|
Summary of Plasma Desethylchloroquine Concentration Versus Time
Hour 0 (Day 0) (n=158)
|
NA ng/ml
Standard Deviation NA
Summary statistics have been calculated by setting concentration values below the low limit of quantification to zero.
|
|
Summary of Plasma Desethylchloroquine Concentration Versus Time
Hour 48 (Day 2) (n=158)
|
183.622 ng/ml
Standard Deviation 118.86488
|
|
Summary of Plasma Desethylchloroquine Concentration Versus Time
Hour 50 (Day 2) (n=147)
|
220.424 ng/ml
Standard Deviation 130.48349
|
|
Summary of Plasma Desethylchloroquine Concentration Versus Time
Hour 56 (Day 2) (n=159)
|
241.831 ng/ml
Standard Deviation 137.88581
|
|
Summary of Plasma Desethylchloroquine Concentration Versus Time
Hour 168 (Day 7) (n=155)
|
144.088 ng/ml
Standard Deviation 123.66303
|
|
Summary of Plasma Desethylchloroquine Concentration Versus Time
Hour 336 (Day 14) (n=154)
|
55.513 ng/ml
Standard Deviation 54.78967
|
|
Summary of Plasma Desethylchloroquine Concentration Versus Time
Hour 504 (Day 21) (n=156)
|
29.825 ng/ml
Standard Deviation 32.41800
|
|
Summary of Plasma Desethylchloroquine Concentration Versus Time
Hour 672 (Day 28) (n=156)
|
19.439 ng/ml
Standard Deviation 19.52079
|
Adverse Events
Azithromycin/Chloroquine (Familial Status = Neonate)
Serious events: 9 serious events
Other events: 20 other events
Deaths: 0 deaths
Azithromycin/Chloroquine (Familial Status = Mother)
Serious events: 0 serious events
Other events: 92 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Azithromycin/Chloroquine (Familial Status = Neonate)
n=157 participants at risk
AZCQ (Familial Status = Neonate)
|
Azithromycin/Chloroquine (Familial Status = Mother)
n=168 participants at risk
ACZQ (Familial Status = Mother)
|
|---|---|---|
|
Congenital, familial and genetic disorders
Hypospadias
|
0.64%
1/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
—
0/0 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Congenital, familial and genetic disorders
Polydactyly
|
0.64%
1/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
—
0/0 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
General disorders
Sudden infant death syndrome
|
0.64%
1/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
—
0/0 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Infections and infestations
Sepsis neonatal
|
0.64%
1/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
—
0/0 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.64%
1/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
—
0/0 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal asphyxia
|
2.5%
4/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
—
0/0 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
Other adverse events
| Measure |
Azithromycin/Chloroquine (Familial Status = Neonate)
n=157 participants at risk
AZCQ (Familial Status = Neonate)
|
Azithromycin/Chloroquine (Familial Status = Mother)
n=168 participants at risk
ACZQ (Familial Status = Mother)
|
|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
6.0%
10/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
0.60%
1/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Eye disorders
Vision blurred
|
0.00%
0/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
0.60%
1/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
1.2%
2/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
0.60%
1/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
0.60%
1/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
1.2%
2/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
1.8%
3/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
0.60%
1/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
3.6%
6/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
20.8%
35/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
General disorders
Asthenia
|
0.00%
0/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
1.8%
3/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
General disorders
Chills
|
0.00%
0/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
0.60%
1/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
General disorders
Fatigue
|
0.00%
0/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
4.2%
7/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
General disorders
Pain
|
0.00%
0/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
0.60%
1/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Infections and infestations
Infection parasitic
|
0.00%
0/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
7.1%
12/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Infections and infestations
Malaria
|
0.00%
0/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
4.8%
8/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Infections and infestations
Trichomoniasis
|
0.00%
0/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
0.60%
1/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
3/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
4.2%
7/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
2.4%
4/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
2.4%
4/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Investigations
White blood cells urine positive
|
0.00%
0/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
0.60%
1/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
0.60%
1/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
0.60%
1/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Nervous system disorders
Dizziness
|
0.00%
0/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
19.6%
33/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Pregnancy, puerperium and perinatal conditions
False labour
|
0.00%
0/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
0.60%
1/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
7.7%
13/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
5.4%
9/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
General disorders
Macrosomia
|
0.64%
1/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
0.00%
0/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Hepatobiliary disorders
Jaundice
|
0.64%
1/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
0.00%
0/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Infections and infestations
Neonatal infection
|
0.64%
1/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
0.00%
0/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Pregnancy, puerperium and perinatal conditions
Low birth weight baby
|
5.1%
8/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
0.00%
0/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
3.8%
6/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
0.00%
0/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Pregnancy, puerperium and perinatal conditions
Umbilical cord around neck
|
0.64%
1/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
0.00%
0/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.64%
1/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
0.00%
0/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal asphyxia
|
1.9%
3/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
0.00%
0/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.64%
1/157 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
0.00%
0/168 • Day 42 follow-up visit for treatment emergent AEs for mothers and 14 days post delivery for neonates
No treatment emergent serious adverse events (SAEs) were observed in mothers. Events related to neonatal malformation/anomalies, premature delivery, low birth weight neonates, developmental assessment, kernicterus, or any other neonatal illness, hospitalization, drug therapy etc, were recorded and presented under the "familial status = neonates"
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER