Trial Outcomes & Findings for A Cohort Study to Determine the Incidence of Dengue Fever and to Build Capacity for Dengue Vaccine Trials in Dengue-endemic Regions of South Asia (NCT NCT02570152)

Last Updated: 2020-07-07

Results Overview

The incidence rate of first event (IR per 1000 person-years) was calculated by dividing the number of subjects reporting at least one episode of event during the follow-up period by the total person-year at risk. The person-time at risk for an event of interest was calculated as the duration between the date of enrolment and the end of the at-risk period or the earliest of the following: onset date of event of interest (e.g. first episode of AFI due to LCD) OR date of last contact OR date of death. An AFI due to LCD was confirmed if all of the following criteria were met: Fever (body temperature greater than or equal to (≥) 38°Celsius \[C\]/≥ 100.4°Farhenheit \[F\] on ≥ 2 consecutive calendar days, measured at least twice, at least 8 hours apart AND Laboratory confirmation of dengue through dengue Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) on acute serum sample taken during the 7-day period (Days 2-7) from the onset of fever (body temperature ≥ 38°C/≥ 100.4°F).

Recruitment status

COMPLETED

Study phase

Target enrollment

2004 participants

Primary outcome timeframe

From first visit to last visit (approximatively 2 years per subject)

Results posted on

2020-07-07

Participant Flow

Participant milestones

Participant milestones
Measure	Study Group Subjects aged between 6 months and 50 years at the time of enrollment, living in randomly selected households in geographically-defined communities. Households including at least one member aged less than 18 years were considered eligible if at least one adult (aged no more than 50 years) and one child (aged less than 18 years) consented (and assented if applicable) to participate in the study.
Overall Study STARTED	2004
Overall Study COMPLETED	1989
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Study Group Subjects aged between 6 months and 50 years at the time of enrollment, living in randomly selected households in geographically-defined communities. Households including at least one member aged less than 18 years were considered eligible if at least one adult (aged no more than 50 years) and one child (aged less than 18 years) consented (and assented if applicable) to participate in the study.
Overall Study Protocol Violation	2
Overall Study Migrated/moved from study area	13

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Group n=2004 Participants Subjects aged between 6 months and 50 years at the time of enrollment, living in randomly selected households in geographically-defined communities. Households including at least one member aged less than 18 years were considered eligible if at least one adult (aged no more than 50 years) and one child (aged less than 18 years) consented (and assented if applicable) to participate in the study.
Age, Continuous	22.3 years STANDARD_DEVIATION 15.1 • n=2004 Participants
Sex: Female, Male Female	1038 Participants n=2004 Participants
Sex: Female, Male Male	966 Participants n=2004 Participants

PRIMARY outcome

Timeframe: From first visit to last visit (approximatively 2 years per subject)

Population: Analysis was performed on the Total cohort that included all subjects enrolled in the study.

Outcome measures

Outcome measures
Measure	Study Group n=2004 Participants Subjects aged between 6 months and 50 years at the time of enrollment, living in randomly selected households in geographically-defined communities. Households including at least one member aged less than 18 years were considered eligible if at least one adult (aged no more than 50 years) and one child (aged less than 18 years) consented (and assented if applicable) to participate in the study.
Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Dengue (LCD) Overall, and by Age Group <5 years	21.25 Person-year rate ( Per 1000) Interval 10.61 to 38.02
Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Dengue (LCD) Overall, and by Age Group 5 to 11 years	22.69 Person-year rate ( Per 1000) Interval 13.66 to 35.44
Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Dengue (LCD) Overall, and by Age Group 12 to 17 years	12.76 Person-year rate ( Per 1000) Interval 5.13 to 26.3
Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Dengue (LCD) Overall, and by Age Group ≥ 18 years	9.16 Person-year rate ( Per 1000) Interval 5.43 to 14.47
Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Dengue (LCD) Overall, and by Age Group Overall	14.21 Person-year rate ( Per 1000) Interval 10.71 to 18.5

SECONDARY outcome

Timeframe: From first visit to last visit (approximatively 2 years per subject)

Population: Analysis was performed on the Total cohort that included all subjects enrolled in the study.

The incidence rate of first event (IR per 1000 person-years) was calculated by dividing the number of subjects reporting at least one episode of event during the follow-up period by the total person-year at risk. The person-time at risk for an event of interest was calculated as the duration between the date of enrolment and the end of the at-risk period or the earliest of the following: onset date of event of interest (e.g. first episode of AFI due to non-LCD) OR date of last contact OR date of death. An AFI due to non-LCD was confirmed if all of the following criteria were met: Fever (body temperature ≥ 38°C/≥ 100.4°F) on ≥ 2 consecutive calendar days, measured at least twice, at least 8 hours apart, AND Dengue RT-qPCR result on the acute serum sample taken during the 7-day period (Days 2-7) from the onset of fever (body temperature ≥ 38°C/≥ 100.4°F) was (valid but) negative for dengue.

Outcome measures

Outcome measures
Measure	Study Group n=2004 Participants Subjects aged between 6 months and 50 years at the time of enrollment, living in randomly selected households in geographically-defined communities. Households including at least one member aged less than 18 years were considered eligible if at least one adult (aged no more than 50 years) and one child (aged less than 18 years) consented (and assented if applicable) to participate in the study.
Incidence Rate of Acute Febrile Illness (AFI) Due to Non-Laboratory Confirmed Dengue (Non-LCD) Overall, and by Age Group <5 years	104.31 Events per 1000 person-year Interval 78.36 to 136.11
Incidence Rate of Acute Febrile Illness (AFI) Due to Non-Laboratory Confirmed Dengue (Non-LCD) Overall, and by Age Group 5 to 11 years	84.8 Events per 1000 person-year Interval 66.23 to 106.97
Incidence Rate of Acute Febrile Illness (AFI) Due to Non-Laboratory Confirmed Dengue (Non-LCD) Overall, and by Age Group 12 to 17 years	43.76 Events per 1000 person-year Interval 28.04 to 65.11
Incidence Rate of Acute Febrile Illness (AFI) Due to Non-Laboratory Confirmed Dengue (Non-LCD) Overall, and by Age Group ≥ 18 years	17.3 Events per 1000 person-year Interval 11.98 to 24.17
Incidence Rate of Acute Febrile Illness (AFI) Due to Non-Laboratory Confirmed Dengue (Non-LCD) Overall, and by Age Group Overall	47.3 Events per 1000 person-year Interval 40.69 to 54.67

SECONDARY outcome

Timeframe: From first visit to last visit (approximatively 2 years per subject)

Population: Analysis was performed on the Total cohort that included all subjects enrolled in the study.

The incidence rate of first event (IR per 1000 person-years) was calculated by dividing the number of subjects reporting at least one episode of event during the follow-up period by the total person-year at risk. The person-time at risk for an event of interest was calculated as the duration between the date of enrolment and the end of the at-risk period or the earliest of the following: onset date of event of interest (e.g. first episode of AFI due to LCD Sero Type 1) OR date of last contact OR date of death. An AFI due to LCD Sero Type 1 was confirmed if all of the following criteria were met: Fever (body temperature greater than or equal to (≥) 38°C/≥ 100.4°F on ≥ 2 consecutive calendar days, measured at least twice, at least 8 hours apart AND Laboratory confirmation of dengue Sero Type 1 through RT-qPCR on acute serum sample taken during the 7-day period (Days 2-7) from the onset of fever (body temperature ≥ 38°C/≥ 100.4°F).

Outcome measures

Outcome measures
Measure	Study Group n=2004 Participants Subjects aged between 6 months and 50 years at the time of enrollment, living in randomly selected households in geographically-defined communities. Households including at least one member aged less than 18 years were considered eligible if at least one adult (aged no more than 50 years) and one child (aged less than 18 years) consented (and assented if applicable) to participate in the study.
Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 1 Dengue Overall, and by Age Group. <5 years	0 Events per 1000 person-year Interval 0.0 to 7.13
Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 1 Dengue Overall, and by Age Group. 5 to 11 years	3.59 Events per 1000 person-year Interval 0.74 to 10.48
Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 1 Dengue Overall, and by Age Group. 12 to 17 years	0 Events per 1000 person-year Interval 0.0 to 6.73
Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 1 Dengue Overall, and by Age Group. ≥ 18	1.53 Events per 1000 person-year Interval 0.31 to 4.46
Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 1 Dengue Overall, and by Age Group. Overall	1.55 Events per 1000 person-year Interval 0.57 to 3.38

SECONDARY outcome

Timeframe: From first visit to last visit (approximatively 2 years per subject)

Population: Analysis was performed on the Total cohort that included all subjects enrolled in the study.

The incidence rate of first event (IR per 1000 person-years) was calculated by dividing the number of subjects reporting at least one episode of event during the follow-up period by the total person-year at risk. The person-time at risk for an event of interest was calculated as the duration between the date of enrolment and the end of the at-risk period or the earliest of the following: onset date of event of interest (e.g. first episode of AFI due to LCD Sero Type 2) OR date of last contact OR date of death. An AFI due to LCD Sero Type 2 was confirmed if all of the following criteria were met: Fever (body temperature greater than or equal to (≥) 38°C/≥ 100.4°F on ≥ 2 consecutive calendar days, measured at least twice, at least 8 hours apart AND Laboratory confirmation of dengue Sero Type 2 through RT-qPCR on acute serum sample taken during the 7-day period (Days 2-7) from the onset of fever (body temperature ≥ 38°C/≥ 100.4°F).

Outcome measures

Outcome measures
Measure	Study Group n=2004 Participants Subjects aged between 6 months and 50 years at the time of enrollment, living in randomly selected households in geographically-defined communities. Households including at least one member aged less than 18 years were considered eligible if at least one adult (aged no more than 50 years) and one child (aged less than 18 years) consented (and assented if applicable) to participate in the study.
Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 2 Dengue Overall, and by Age Group <5 years	21.25 Events per 1000 person-year Interval 10.61 to 38.02
Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 2 Dengue Overall, and by Age Group 5 to 11 years	17.94 Events per 1000 person-year Interval 10.04 to 29.58
Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 2 Dengue Overall, and by Age Group 12 to 17 years	12.76 Events per 1000 person-year Interval 5.13 to 26.3
Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 2 Dengue Overall, and by Age Group ≥ 18 years	6.61 Events per 1000 person-year Interval 3.52 to 11.31
Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 2 Dengue Overall, and by Age Group Overall	11.89 Events per 1000 person-year Interval 8.71 to 15.86

SECONDARY outcome

Timeframe: From first visit to last visit (approximatively 2 years per subject)

Population: Analysis was performed on the Total cohort that included all subjects enrolled in the study

The incidence rate of first event (IR per 1000 person-years) was calculated by dividing the number of subjects reporting at least one episode of event during the follow-up period by the total person-year at risk. The person-time at risk for an event of interest was calculated as the duration between the date of enrolment and the end of the at-risk period or the earliest of the following: onset date of event of interest (e.g. first episode of AFI due to LCD Sero Type 3) OR date of last contact OR date of death. An AFI due to LCD Sero Type 3 was confirmed if all of the following criteria were met: Fever (body temperature greater than or equal to (≥) 38°C/≥ 100.4°F on ≥ 2 consecutive calendar days, measured at least twice, at least 8 hours apart AND Laboratory confirmation of dengue Sero Type 3 through RT-qPCR on acute serum sample taken during the 7-day period (Days 2-7) from the onset of fever (body temperature ≥ 38°C/≥ 100.4°F)

Outcome measures

Outcome measures
Measure	Study Group n=2004 Participants Subjects aged between 6 months and 50 years at the time of enrollment, living in randomly selected households in geographically-defined communities. Households including at least one member aged less than 18 years were considered eligible if at least one adult (aged no more than 50 years) and one child (aged less than 18 years) consented (and assented if applicable) to participate in the study.
Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 3 Dengue Overall, and by Age Group <5 years	0 Events per 1000 person-year Interval 0.0 to 7.13
Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 3 Dengue Overall, and by Age Group 5 to 11 years	1.2 Events per 1000 person-year Interval 0.03 to 6.66
Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 3 Dengue Overall, and by Age Group 12 to 17 years	0 Events per 1000 person-year Interval 0.0 to 6.73
Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 3 Dengue Overall, and by Age Group ≥ 18	1.02 Events per 1000 person-year Interval 0.12 to 3.68
Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 3 Dengue Overall, and by Age Group Overall	0.78 Events per 1000 person-year Interval 0.16 to 2.27

SECONDARY outcome

Timeframe: From first visit to last visit (approximatively 2 years per subject)

Population: Analysis was performed on the Total cohort that included all subjects enrolled in the study.

The incidence rate of first event (IR per 1000 person-years) was calculated by dividing the number of subjects reporting at least one episode of event during the follow-up period by the total person-year at risk. The person-time at risk for an event of interest was calculated as the duration between the date of enrolment and the end of the at-risk period or the earliest of the following: onset date of event of interest (e.g. first episode of AFI due to LCD Sero Type 4) OR date of last contact OR date of death. An AFI due to LCD Sero Type 4 was confirmed if all of the following criteria were met: Fever (body temperature greater than or equal to (≥) 38°C/≥ 100.4°F on ≥ 2 consecutive calendar days, measured at least twice, at least 8 hours apart AND Laboratory confirmation of dengue Sero Type 4 through RT-qPCR on acute serum sample taken during the 7-day period (Days 2-7) from the onset of fever (body temperature ≥ 38°C/≥ 100.4°F)

Outcome measures

Outcome measures
Measure	Study Group n=2004 Participants Subjects aged between 6 months and 50 years at the time of enrollment, living in randomly selected households in geographically-defined communities. Households including at least one member aged less than 18 years were considered eligible if at least one adult (aged no more than 50 years) and one child (aged less than 18 years) consented (and assented if applicable) to participate in the study.
Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 4 Dengue Overall, and by Age Group <5 years	0 Events per 1000 person-year Interval 0.0 to 7.13
Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 4 Dengue Overall, and by Age Group 5 to 11 years	0 Events per 1000 person-year Interval 0.0 to 4.41
Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 4 Dengue Overall, and by Age Group 12 to 17 years	0 Events per 1000 person-year Interval 0.0 to 6.73
Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 4 Dengue Overall, and by Age Group ≥ 18	0 Events per 1000 person-year Interval 0.0 to 1.88
Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 4 Dengue Overall, and by Age Group Overall	0 Events per 1000 person-year Interval 0.0 to 0.95

SECONDARY outcome

Timeframe: At each day during the 7-day period following the onset of each episode of AFI due to LCD

Population: Analysis was performed on all subjects enrolled in the study and with AFI due to LCD.

Description of signs and symptoms of AFI due to LCD included the percentage of AFI presenting each sign or symptom (any intensity) during the 7-day period from the onset of fever (body temperature 38°C/100.4°F).

Outcome measures

Outcome measures
Measure	Study Group n=55 AFI episodes Subjects aged between 6 months and 50 years at the time of enrollment, living in randomly selected households in geographically-defined communities. Households including at least one member aged less than 18 years were considered eligible if at least one adult (aged no more than 50 years) and one child (aged less than 18 years) consented (and assented if applicable) to participate in the study.
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Headache / irritability at Day 1	51 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Headache / irritability at Day 2	51 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Headache / irritability at Day 3	51 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Headache / irritability at Day 4	51 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Headache / irritability at Day 5	51 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Headache / irritability at Day 6	50 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Headache / irritability at Day 7	50 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Eye pain at Day 1	34 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Eye pain at Day 2	34 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Eye pain at Day 3	34 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Eye pain at Day 4	34 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Eye pain at Day 5	34 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Eye pain at Day 6	34 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Eye pain at Day 7	34 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Myalgia (muscle pain) at Day 1	47 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Myalgia (muscle pain) at Day 2	47 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Myalgia (muscle pain) at Day 3	47 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Myalgia (muscle pain) at Day 4	47 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Myalgia (muscle pain) at Day 5	47 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Myalgia (muscle pain) at Day 6	47 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Myalgia (muscle pain) at Day 7	47 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Arthralgia (joint pain) at Day 1	42 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Arthralgia (joint pain) at Day 2	42 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Arthralgia (joint pain) at Day 3	42 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Arthralgia (joint pain) at Day 4	42 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Arthralgia (joint pain) at Day 5	42 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Arthralgia (joint pain) at Day 6	42 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Arthralgia (joint pain) at Day 7	42 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Abdominal pain at Day 1	31 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Abdominal pain at Day 2	31 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Abdominal pain at Day 3	31 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Abdominal pain at Day 4	31 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Abdominal pain at Day 5	31 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Abdominal pain at Day 6	31 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Abdominal pain at Day 7	31 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Nausea at Day 1	29 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Nausea at Day 2	29 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Nausea at Day 3	29 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Nausea at Day 4	29 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Nausea at Day 5	29 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Nausea at Day 6	29 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Nausea at Day 7	29 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Vomiting at Day 1	29 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Vomiting at Day 2	29 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Vomiting at Day 3	29 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Vomiting at Day 4	29 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Vomiting at Day 5	29 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Vomiting at Day 6	29 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Vomiting at Day 7	29 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Rash at Day 1	5 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Rash at Day 2	5 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Rash at Day 3	5 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Rash at Day 4	5 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Rash at Day 5	5 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Rash at Day 6	5 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Rash at Day 7	5 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Any bleeding (skin, mouth, anus) at Day 1	4 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Any bleeding (skin, mouth, anus) at Day 2	4 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Any bleeding (skin, mouth, anus) at Day 3	4 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Any bleeding (skin, mouth, anus) at Day 4	4 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Any bleeding (skin, mouth, anus) at Day 5	4 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Any bleeding (skin, mouth, anus) at Day 6	4 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Any bleeding (skin, mouth, anus) at Day 7	4 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Loss of appetite at Day 1	43 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Loss of appetite at Day 2	43 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Loss of appetite at Day 3	43 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Loss of appetite at Day 4	43 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Loss of appetite at Day 5	43 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Loss of appetite at Day 6	43 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Loss of appetite at Day 7	43 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Fatigue/decrease in normal activity at Day 1	48 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Fatigue/decrease in normal activity at Day 2	48 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Fatigue/decrease in normal activity at Day 3	48 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Fatigue/decrease in normal activity at Day 4	48 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Fatigue/decrease in normal activity at Day 5	48 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Fatigue/decrease in normal activity at Day 6	48 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Fatigue/decrease in normal activity at Day 7	48 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Reduced fluid intake at Day 1	33 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Reduced fluid intake at Day 2	33 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Reduced fluid intake at Day 3	33 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Reduced fluid intake at Day 4	33 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Reduced fluid intake at Day 5	33 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Reduced fluid intake at Day 6	33 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. Reduced fluid intake at Day 7	33 AFI episodes

SECONDARY outcome

Timeframe: At each day during the 7-day period following the onset of each episode of AFI due to LCD

Population: Analysis was performed on all subjects enrolled in the study and with AFI due to LCD.

Description of signs and symptoms of AFI due to LCD included the percentage of AFI presenting each sign or symptom (grade 3) during the 7-day period from the onset of fever (body temperature 38°C/100.4°F).

Outcome measures

Outcome measures
Measure	Study Group n=55 AFI episodes Subjects aged between 6 months and 50 years at the time of enrollment, living in randomly selected households in geographically-defined communities. Households including at least one member aged less than 18 years were considered eligible if at least one adult (aged no more than 50 years) and one child (aged less than 18 years) consented (and assented if applicable) to participate in the study.
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Headache / irritability at Day 1	11 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Headache / irritability at Day 2	11 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Headache / irritability at Day 3	11 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Headache / irritability at Day 4	11 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Headache / irritability at Day 5	11 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Headache / irritability at Day 6	11 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Headache / irritability at Day 7	11 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Eye pain at Day 1	2 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Eye pain at Day 2	2 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Eye pain at Day 3	2 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Eye pain at Day 4	2 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Eye pain at Day 5	2 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Eye pain at Day 6	2 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Eye pain at Day 7	2 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Myalgia (muscle pain) at Day 1	10 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Myalgia (muscle pain) at Day 2	10 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Myalgia (muscle pain) at Day 3	10 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Myalgia (muscle pain) at Day 4	10 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Myalgia (muscle pain) at Day 5	10 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Myalgia (muscle pain) at Day 6	10 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Myalgia (muscle pain) at Day 7	10 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Arthralgia (joint pain) at Day 1	8 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Arthralgia (joint pain) at Day 2	8 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Arthralgia (joint pain) at Day 3	8 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Arthralgia (joint pain) at Day 4	8 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Arthralgia (joint pain) at Day 5	8 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Arthralgia (joint pain) at Day 6	8 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Arthralgia (joint pain) at Day 7	8 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Abdominal pain at Day 1	2 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Abdominal pain at Day 2	2 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Abdominal pain at Day 3	2 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Abdominal pain at Day 4	2 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Abdominal pain at Day 5	2 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Abdominal pain at Day 6	2 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Abdominal pain at Day 7	2 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Vomiting at Day 1	1 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Vomiting at Day 2	1 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Vomiting at Day 3	1 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Vomiting at Day 4	1 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Vomiting at Day 5	1 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Vomiting at Day 6	1 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Vomiting at Day 7	1 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Rash at Day 1	1 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Rash at Day 2	1 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Rash at Day 3	1 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Rash at Day 4	1 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Rash at Day 5	1 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Rash at Day 6	1 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Rash at Day 7	1 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Loss of appetite at Day 1	8 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Loss of appetite at Day 2	8 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Loss of appetite at Day 3	8 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Loss of appetite at Day 4	8 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Loss of appetite at Day 5	8 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Loss of appetite at Day 6	8 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Loss of appetite at Day 7	8 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Fatigue/decrease in normal activity at Day 1	14 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Fatigue/decrease in normal activity at Day 2	14 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Fatigue/decrease in normal activity at Day 3	14 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Fatigue/decrease in normal activity at Day 4	14 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Fatigue/decrease in normal activity at Day 5	14 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Fatigue/decrease in normal activity at Day 6	14 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Fatigue/decrease in normal activity at Day 7	14 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Reduced fluid intake at Day 1	4 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Reduced fluid intake at Day 2	4 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Reduced fluid intake at Day 3	4 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Reduced fluid intake at Day 4	4 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Reduced fluid intake at Day 5	4 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Reduced fluid intake at Day 6	4 AFI episodes
Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD Reduced fluid intake at Day 7	4 AFI episodes

SECONDARY outcome

Timeframe: At each day during the 7-day period following the onset of each episode of AFI due to non-LCD

Population: Analysis was performed on all subjects enrolled in the study and with AFI due to non-LCD.

Description of signs and symptoms of AFI due to non-LCD included the percentage of AFI presenting each sign or symptom (any intensity) during the 7-day period from the onset of fever (body temperature 38°C/100.4°F).

Outcome measures

Outcome measures
Measure	Study Group n=183 AFI episodes Subjects aged between 6 months and 50 years at the time of enrollment, living in randomly selected households in geographically-defined communities. Households including at least one member aged less than 18 years were considered eligible if at least one adult (aged no more than 50 years) and one child (aged less than 18 years) consented (and assented if applicable) to participate in the study.
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Reduced fluid intake at Day 5	103 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Reduced fluid intake at Day 6	103 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Reduced fluid intake at Day 7	102 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Headache / irritability at Day 1	159 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Headache / irritability at Day 2	159 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Headache / irritability at Day 3	159 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Headache / irritability at Day 4	157 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Headache / irritability at Day 5	158 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Headache / irritability at Day 6	158 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Headache / irritability at Day 7	158 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Eye pain at Day 1	80 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Eye pain at Day 2	80 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Eye pain at Day 3	80 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Eye pain at Day 4	78 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Eye pain at Day 5	79 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Eye pain at Day 6	79 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Eye pain at Day 7	78 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Myalgia (muscle pain) at Day 1	133 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Myalgia (muscle pain) at Day 2	133 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Myalgia (muscle pain) at Day 3	133 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Myalgia (muscle pain) at Day 4	131 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Myalgia (muscle pain) at Day 5	132 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Myalgia (muscle pain) at Day 6	132 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Myalgia (muscle pain) at Day 7	132 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Arthralgia (joint pain at Day 1	118 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Arthralgia (joint pain at Day 2	118 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Arthralgia (joint pain at Day 3	118 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Arthralgia (joint pain at Day 4	116 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Arthralgia (joint pain at Day 5	117 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Arthralgia (joint pain at Day 6	117 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Arthralgia (joint pain at Day 7	117 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Abdominal pain at Day 1	87 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Abdominal pain at Day 2	87 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Abdominal pain at Day 3	87 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Abdominal pain at Day 4	86 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Abdominal pain at Day 5	87 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Abdominal pain at Day 6	87 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Abdominal pain at Day 7	87 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Nausea at Day 1	92 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Nausea at Day 2	92 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Nausea at Day 3	92 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Nausea at Day 4	90 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Nausea at Day 5	91 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Nausea at Day 6	91 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Nausea at Day 7	91 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Vomiting at Day 1	71 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Vomiting at Day 2	71 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Vomiting at Day 3	71 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Vomiting at Day 4	70 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Vomiting at Day 5	71 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Vomiting at Day 6	71 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Vomiting at Day 7	71 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Rash at Day 1	7 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Rash at Day 2	7 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Rash at Day 3	7 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Rash at Day 4	7 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Rash at Day 5	7 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Rash at Day 6	7 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Rash at Day 7	7 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Any bleeding (skin, mouth, anus) at Day 1	6 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Any bleeding (skin, mouth, anus) at Day 2	6 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Any bleeding (skin, mouth, anus) at Day 3	6 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Any bleeding (skin, mouth, anus) at Day 4	6 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Any bleeding (skin, mouth, anus) at Day 5	6 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Any bleeding (skin, mouth, anus) at Day 6	6 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Any bleeding (skin, mouth, anus) at Day 7	6 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Loss of appetite at Day 1	140 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Loss of appetite at Day 2	140 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Loss of appetite at Day 3	140 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Loss of appetite at Day 4	138 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Loss of appetite at Day 5	139 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Loss of appetite at Day 6	139 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Loss of appetite at Day 7	137 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Fatigue/decrease in normal activity at Day 1	152 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Fatigue/decrease in normal activity at Day 2	152 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Fatigue/decrease in normal activity at Day 3	152 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Fatigue/decrease in normal activity at Day 4	150 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Fatigue/decrease in normal activity at Day 5	151 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Fatigue/decrease in normal activity at Day 6	151 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Fatigue/decrease in normal activity at Day 7	150 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Reduced fluid intake at Day 1	105 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Reduced fluid intake at Day 2	105 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Reduced fluid intake at Day 3	105 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Reduced fluid intake at Day 4	103 AFI episodes

SECONDARY outcome

Timeframe: At each day during the 7-day period following the onset of each episode of AFI due to non-LCD

Population: Analysis was performed on all subjects enrolled in the study and with AFI due to non-LCD.

Description of signs and symptoms of AFI due to non-LCD included the percentage of AFI presenting each sign or symptom (grade 3) during the 7-day period from the onset of fever (body temperature 38°C/100.4°F).

Outcome measures

Outcome measures
Measure	Study Group n=183 AFI episodes Subjects aged between 6 months and 50 years at the time of enrollment, living in randomly selected households in geographically-defined communities. Households including at least one member aged less than 18 years were considered eligible if at least one adult (aged no more than 50 years) and one child (aged less than 18 years) consented (and assented if applicable) to participate in the study.
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Rash at Day 2	1 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Rash at Day 3	1 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Rash at Day 4	1 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Rash at Day 5	1 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Rash at Day 6	1 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Rash at Day 7	1 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Loss of appetite at Day 1	11 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Loss of appetite at Day 2	11 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Loss of appetite at Day 3	11 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Loss of appetite at Day 4	11 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Loss of appetite at Day 5	11 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Loss of appetite at Day 6	11 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Loss of appetite at Day 7	11 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Fatigue/decrease in normal activity at Day 1	17 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Fatigue/decrease in normal activity at Day 2	17 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Fatigue/decrease in normal activity at Day 3	17 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Fatigue/decrease in normal activity at Day 4	16 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Fatigue/decrease in normal activity at Day 5	17 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Fatigue/decrease in normal activity at Day 6	17 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Fatigue/decrease in normal activity at Day 7	17 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Reduced fluid intake at Day 1	5 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Reduced fluid intake at Day 2	5 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Reduced fluid intake at Day 3	5 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Reduced fluid intake at Day 4	5 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Headache / irritability at Day 1	16 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Headache / irritability at Day 2	16 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Headache / irritability at Day 3	16 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Reduced fluid intake at Day 5	5 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Headache / irritability at Day 4	15 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Headache / irritability at Day 5	16 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Headache / irritability at Day 6	16 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Headache / irritability at Day 7	16 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Eye pain at Day 1	5 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Eye pain at Day 2	5 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Eye pain at Day 3	5 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Eye pain at Day 4	5 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Eye pain at Day 5	5 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Eye pain at Day 6	5 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Eye pain at Day 7	5 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Myalgia (muscle pain) at Day 1	14 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Myalgia (muscle pain) at Day 2	14 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Myalgia (muscle pain) at Day 3	14 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Myalgia (muscle pain) at Day 4	13 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Myalgia (muscle pain) at Day 5	14 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Myalgia (muscle pain) at Day 6	14 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Myalgia (muscle pain) at Day 7	14 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Arthralgia (joint pain) at Day 1	12 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Arthralgia (joint pain) at Day 2	12 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Arthralgia (joint pain) at Day 3	12 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Arthralgia (joint pain) at Day 4	11 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Arthralgia (joint pain) at Day 5	12 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Arthralgia (joint pain) at Day 6	12 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Arthralgia (joint pain) at Day 7	12 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Abdominal pain at Day 1	4 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Abdominal pain at Day 2	4 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Abdominal pain at Day 3	4 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Abdominal pain at Day 4	3 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Abdominal pain at Day 5	4 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Abdominal pain at Day 6	4 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Abdominal pain at Day 7	4 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Nausea at Day 1	4 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Nausea at Day 2	4 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Nausea at Day 3	4 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Nausea at Day 4	3 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Nausea at Day 5	4 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Nausea at Day 6	4 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Nausea at Day 7	4 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Vomiting at Day 1	4 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Vomiting at Day 2	4 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Vomiting at Day 3	4 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Vomiting at Day 4	3 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Vomiting at Day 5	4 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Vomiting at Day 6	4 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Vomiting at Day 7	4 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Rash at Day 1	1 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Reduced fluid intake at Day 6	5 AFI episodes
Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD Reduced fluid intake at Day 7	5 AFI episodes

SECONDARY outcome

Timeframe: From first visit to last visit (approximatively 2 years per subject)

Population: Analysis was performed on the Total cohort that included all subjects enrolled in the study.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Study Group n=2004 Participants Subjects aged between 6 months and 50 years at the time of enrollment, living in randomly selected households in geographically-defined communities. Households including at least one member aged less than 18 years were considered eligible if at least one adult (aged no more than 50 years) and one child (aged less than 18 years) consented (and assented if applicable) to participate in the study.
Number of Subjects With Serious Adverse Events (SAEs) Related to a Study Procedure	0 Participants

Adverse Events

Study Group

Serious events: 0 serious events

Other events: 216 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Study Group n=2004 participants at risk Subjects aged between 6 months and 50 years at the time of enrollment, living in randomly selected households in geographically-defined communities. Households including at least one member aged less than 18 years were considered eligible if at least one adult (aged no more than 50 years) and one child (aged less than 18 years) consented (and assented if applicable) to participate in the study.
General disorders Abdominal pain	5.4% 109/2004 • Number of events 109 • Any signs or symptoms were collected during the 7-day period following the onset of fever. Serious adverse events were collected from first visit to last visit (approximately 2 years per subject). The signs or symptoms collected were specified in the protocol and were not classified per MedDRA dictionary.
General disorders Arthralgia	7.3% 147/2004 • Number of events 147 • Any signs or symptoms were collected during the 7-day period following the onset of fever. Serious adverse events were collected from first visit to last visit (approximately 2 years per subject). The signs or symptoms collected were specified in the protocol and were not classified per MedDRA dictionary.
General disorders Bleeding	0.50% 10/2004 • Number of events 10 • Any signs or symptoms were collected during the 7-day period following the onset of fever. Serious adverse events were collected from first visit to last visit (approximately 2 years per subject). The signs or symptoms collected were specified in the protocol and were not classified per MedDRA dictionary.
General disorders Eye pain	5.3% 106/2004 • Number of events 106 • Any signs or symptoms were collected during the 7-day period following the onset of fever. Serious adverse events were collected from first visit to last visit (approximately 2 years per subject). The signs or symptoms collected were specified in the protocol and were not classified per MedDRA dictionary.
General disorders Fatigue	9.3% 186/2004 • Number of events 186 • Any signs or symptoms were collected during the 7-day period following the onset of fever. Serious adverse events were collected from first visit to last visit (approximately 2 years per subject). The signs or symptoms collected were specified in the protocol and were not classified per MedDRA dictionary.
General disorders Headache	9.6% 192/2004 • Number of events 192 • Any signs or symptoms were collected during the 7-day period following the onset of fever. Serious adverse events were collected from first visit to last visit (approximately 2 years per subject). The signs or symptoms collected were specified in the protocol and were not classified per MedDRA dictionary.
General disorders Loss of appetite	8.3% 166/2004 • Number of events 166 • Any signs or symptoms were collected during the 7-day period following the onset of fever. Serious adverse events were collected from first visit to last visit (approximately 2 years per subject). The signs or symptoms collected were specified in the protocol and were not classified per MedDRA dictionary.
General disorders Nausea	5.6% 113/2004 • Number of events 113 • Any signs or symptoms were collected during the 7-day period following the onset of fever. Serious adverse events were collected from first visit to last visit (approximately 2 years per subject). The signs or symptoms collected were specified in the protocol and were not classified per MedDRA dictionary.
General disorders Rash	0.55% 11/2004 • Number of events 11 • Any signs or symptoms were collected during the 7-day period following the onset of fever. Serious adverse events were collected from first visit to last visit (approximately 2 years per subject). The signs or symptoms collected were specified in the protocol and were not classified per MedDRA dictionary.
General disorders Reduced fluid intake	6.4% 128/2004 • Number of events 128 • Any signs or symptoms were collected during the 7-day period following the onset of fever. Serious adverse events were collected from first visit to last visit (approximately 2 years per subject). The signs or symptoms collected were specified in the protocol and were not classified per MedDRA dictionary.
General disorders Vomiting	4.9% 99/2004 • Number of events 99 • Any signs or symptoms were collected during the 7-day period following the onset of fever. Serious adverse events were collected from first visit to last visit (approximately 2 years per subject). The signs or symptoms collected were specified in the protocol and were not classified per MedDRA dictionary.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 877-379-3718

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER