Trial Outcomes & Findings for Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples (NCT NCT00557245)
NCT ID: NCT00557245
Last Updated: 2019-04-19
Results Overview
The efficacy of once daily PrEP in preventing HIV-1 acquisition among uninfected heterosexuals in HIV-1 discordant partnerships, measured by calculating the HIV incidence per 100 person-years in each of three arms.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
4758 participants
Primary outcome timeframe
Up to 36 months
Results posted on
2019-04-19
Participant Flow
Participant milestones
| Measure |
Tenofovir Disoproxil Fumarate (TDF)
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
|
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
|
Placebo
Placebo TDF \& Placebo FTC/TDF, 1 tablet each daily.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1589
|
1583
|
1586
|
|
Overall Study
COMPLETED
|
1577
|
1571
|
1574
|
|
Overall Study
NOT COMPLETED
|
12
|
12
|
12
|
Reasons for withdrawal
| Measure |
Tenofovir Disoproxil Fumarate (TDF)
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
|
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
|
Placebo
Placebo TDF \& Placebo FTC/TDF, 1 tablet each daily.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
8
|
10
|
|
Overall Study
Ineligible
|
5
|
4
|
2
|
Baseline Characteristics
Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples
Baseline characteristics by cohort
| Measure |
Tenofovir Disoproxil Fumarate (TDF)
n=1584 Participants
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
|
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
n=1579 Participants
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
|
Placebo
n=1584 Participants
Placebo TDF \& Placebo FTC/TDF, 1 tablet each daily.
|
Total
n=4747 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18-24 years
|
184 participants
n=5 Participants
|
177 participants
n=7 Participants
|
172 participants
n=5 Participants
|
533 participants
n=4 Participants
|
|
Age, Customized
25-34 years
|
721 participants
n=5 Participants
|
690 participants
n=7 Participants
|
688 participants
n=5 Participants
|
2099 participants
n=4 Participants
|
|
Age, Customized
35-44 years
|
480 participants
n=5 Participants
|
498 participants
n=7 Participants
|
513 participants
n=5 Participants
|
1491 participants
n=4 Participants
|
|
Age, Customized
45 years and older
|
199 participants
n=5 Participants
|
214 participants
n=7 Participants
|
211 participants
n=5 Participants
|
624 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
598 Participants
n=5 Participants
|
566 Participants
n=7 Participants
|
621 Participants
n=5 Participants
|
1785 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
986 Participants
n=5 Participants
|
1013 Participants
n=7 Participants
|
963 Participants
n=5 Participants
|
2962 Participants
n=4 Participants
|
|
Region of Enrollment
Kenya
|
700 participants
n=5 Participants
|
698 participants
n=7 Participants
|
697 participants
n=5 Participants
|
2095 participants
n=4 Participants
|
|
Region of Enrollment
Uganda
|
884 participants
n=5 Participants
|
881 participants
n=7 Participants
|
887 participants
n=5 Participants
|
2652 participants
n=4 Participants
|
|
Percentage of participants who had unprotected sex in the past month
|
27.9 percentage of participants
n=5 Participants
|
26.3 percentage of participants
n=7 Participants
|
25.8 percentage of participants
n=5 Participants
|
26.7 percentage of participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 36 monthsPopulation: All randomized participants, less those who were found to ineligible (n=11), less those found to be infected at enrollment (n=14), and less those who did not return for any follow-up (n=25).
The efficacy of once daily PrEP in preventing HIV-1 acquisition among uninfected heterosexuals in HIV-1 discordant partnerships, measured by calculating the HIV incidence per 100 person-years in each of three arms.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate (TDF)
n=1572 Participants
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
|
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
n=1568 Participants
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
|
Placebo
n=1568 Participants
Placebo TDF \& Placebo FTC/TDF, 1 tablet each daily.
|
|---|---|---|---|
|
Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants
|
0.65 events per 100 person years
Interval 0.38 to 1.05
|
0.50 events per 100 person years
Interval 0.27 to 0.85
|
1.99 events per 100 person years
Interval 1.49 to 2.62
|
PRIMARY outcome
Timeframe: Up to 36 monthsPopulation: Randomized participants, less those found to be ineligible (n=11)
Safety of daily TDF or FTC/TDF among HIV-1 uninfected individuals randomized to TDF or FTC/TDF compared to those randomized to placebo measured as the number of participants with Serious Adverse Events (SAEs) during follow-up.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate (TDF)
n=1584 Participants
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
|
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
n=1579 Participants
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
|
Placebo
n=1584 Participants
Placebo TDF \& Placebo FTC/TDF, 1 tablet each daily.
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
118 Participants
|
115 Participants
|
118 Participants
|
SECONDARY outcome
Timeframe: Up to 36 monthsAdherence to study medication as assessed by pill count at follow-up visits. We assessed the total number of doses taken of the total dispensed doses.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate (TDF)
n=1571 Participants
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
|
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
n=1565 Participants
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
|
Placebo
n=1570 Participants
Placebo TDF \& Placebo FTC/TDF, 1 tablet each daily.
|
|---|---|---|---|
|
Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses.
|
97 percentage of doses taken of dispensed
|
97 percentage of doses taken of dispensed
|
97 percentage of doses taken of dispensed
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Participants with self-reported adherence.
Adherence to study drug measured as the percentage of visits when participants reported missing 1) any dose of study drug in the prior month and 2) 2 or more consecutive doses of study drug.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate (TDF)
n=1549 Participants
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
|
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
n=1552 Participants
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
|
Placebo
n=1551 Participants
Placebo TDF \& Placebo FTC/TDF, 1 tablet each daily.
|
|---|---|---|---|
|
Study Drug Adherence: Self-reported Missed Doses of Study Drug
Missed any doses
|
15 percentage of visits
|
15 percentage of visits
|
15 percentage of visits
|
|
Study Drug Adherence: Self-reported Missed Doses of Study Drug
Missed 2+ consecutive doses
|
4 percentage of visits
|
4 percentage of visits
|
4 percentage of visits
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Participants who seroconverted during the Partners PrEP trial, including those who were retrospectively found to be HIV infected at enrollment (TDF arm: n=5; FTC-TDF arm: n=3; placebo arm: n=6). For 4 of 96 HIV-1 seroconverters (TDF arm: n=2; FTC-TDF arm: n=1; placebo arm: n=1) HIV-1 RNA was unable to be amplified for HIV-1 resistance testing.
HIV-1 resistance as measured by the number of seroconverters who had an HIV-1 reverse transcriptase mutation (K65R, K70E, M184I, or M184V) conferring resistance to TDF or FTC. These mutation types were pre-defined. Plasma samples for resistance testing were collected at the visit seroconversion was first detected and again at a visit within 1 month of seroconversion. Mutations detected at either of those visits are reported. Both seroconverters found to have a resistance mutation had been HIV infected at enrollment (TDF arm: n=1; FTC-TDF arm: n=1).
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate (TDF)
n=20 Participants
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
|
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
n=15 Participants
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
|
Placebo
n=57 Participants
Placebo TDF \& Placebo FTC/TDF, 1 tablet each daily.
|
|---|---|---|---|
|
Number of Seroconverters With an HIV-1 Mutation Conferring Resistance to TDF or FTC
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Randomized participants, less those found to be ineligible (n=11)
Prevalence of STIs measured as the number of participants with a positive test result for N. gonorrhoeae, C. trachomatis, or T. vaginalis during follow-up. Participants were tested for STIs at annual follow-up visits and at intervening visits at which the participant presented with symptoms of an STI. Assessment for symptomatic sexually transmitted infections was conducted quarterly. N. gonorrhoeae and C. trachomatis testing were by APTIMA Combo 2 (Gen-Probe) or COBAS Amplicor (Roche Diagnostics). T. vaginalis testing was by APTIMA TV TMA (Gen-Probe) or In Pouch TV (Biomed Diagnostics).
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate (TDF)
n=1584 Participants
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
|
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
n=1579 Participants
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
|
Placebo
n=1584 Participants
Placebo TDF \& Placebo FTC/TDF, 1 tablet each daily.
|
|---|---|---|---|
|
Number of Participants With a Sexually Transmitted Infection (STI) During Follow-up
|
102 participants
|
76 participants
|
85 participants
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: All randomized participants, less those found to be ineligible (n=11).
Sexual risk behavior of participants, measured as the percentage of visits when participants reported having unprotected sex during follow-up.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate (TDF)
n=1584 Participants
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
|
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
n=1579 Participants
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
|
Placebo
n=1584 Participants
Placebo TDF \& Placebo FTC/TDF, 1 tablet each daily.
|
|---|---|---|---|
|
Prevalence of Unprotected Sex During Follow-up
|
14 percentage of visits
|
13 percentage of visits
|
13 percentage of visits
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Randomized female participants, less those found to be ineligible (n=7)
Infant outcomes measured as the number of live-born infants born to female participants taking study drug that had any congenital anomalies.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate (TDF)
n=81 live-born infants
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
|
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
n=47 live-born infants
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
|
Placebo
n=66 live-born infants
Placebo TDF \& Placebo FTC/TDF, 1 tablet each daily.
|
|---|---|---|---|
|
Congenital Abnormalities Among Infants Born to Female Participants Taking Study Drug.
|
4 Number of live-born infants
|
4 Number of live-born infants
|
5 Number of live-born infants
|
SECONDARY outcome
Timeframe: up to 12 monthsPopulation: Infants born to women taking study drug during follow-up
The slope of the linear model of the growth of infants (length) during the entirety of follow-up. The length of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate (TDF)
n=81 Participants
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
|
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
n=47 Participants
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
|
Placebo
n=66 Participants
Placebo TDF \& Placebo FTC/TDF, 1 tablet each daily.
|
|---|---|---|---|
|
Length Among Infants Born to Female Participants Taking Study Drug
|
-0.006 z-score difference per study month
|
0.036 z-score difference per study month
|
-0.033 z-score difference per study month
|
SECONDARY outcome
Timeframe: up to 12 monthsPopulation: Infants born to women taking study drug during follow-up
The slope of the linear model of the growth of infants (weight) during the entirety of follow-up. The weight of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate (TDF)
n=81 Participants
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
|
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
n=47 Participants
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
|
Placebo
n=66 Participants
Placebo TDF \& Placebo FTC/TDF, 1 tablet each daily.
|
|---|---|---|---|
|
Weight Among Infants Born to Female Participants Taking Study Drug
|
-0.021 z-score difference per study month
|
0.009 z-score difference per study month
|
-0.056 z-score difference per study month
|
SECONDARY outcome
Timeframe: up to 12 monthsPopulation: Infants born to women taking study drug during follow-up
The slope of the linear model of the growth of infants (head circumference) during the entirety of follow-up. The head circumference of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate (TDF)
n=81 Participants
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
|
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
n=47 Participants
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
|
Placebo
n=66 Participants
Placebo TDF \& Placebo FTC/TDF, 1 tablet each daily.
|
|---|---|---|---|
|
Head Circumference Among Infants Born to Female Participants Taking Study Drug
|
-0.057 z-score difference per study month
|
-0.005 z-score difference per study month
|
-0.079 z-score difference per study month
|
Adverse Events
Tenofovir Disoproxil Fumarate (TDF)
Serious events: 118 serious events
Other events: 1306 other events
Deaths: 0 deaths
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
Serious events: 115 serious events
Other events: 1316 other events
Deaths: 0 deaths
Placebo
Serious events: 118 serious events
Other events: 1297 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tenofovir Disoproxil Fumarate (TDF)
n=1584 participants at risk
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
|
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
n=1579 participants at risk
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
|
Placebo
n=1584 participants at risk
Placebo TDF \& Placebo FTC/TDF, 1 tablet each daily.
|
|---|---|---|---|
|
Congenital, familial and genetic disorders
ANKYLOGLOSSIA CONGENITAL
|
0.13%
2/1584 • Number of events 2 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Congenital, familial and genetic disorders
EXOMPHALOS
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Congenital, familial and genetic disorders
HYPOSPADIAS
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Congenital, familial and genetic disorders
POLYDACTYLY
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Congenital, familial and genetic disorders
SYNDACTYLY
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Congenital, familial and genetic disorders
VENTRICULAR SEPTAL DEFECT
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Eye disorders
BLINDNESS
|
0.00%
0/1584 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Eye disorders
CATARACT
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Eye disorders
OPTIC NEUROPATHY
|
0.00%
0/1584 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Gastrointestinal disorders
ABDOMINAL HERNIA
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.13%
2/1579 • Number of events 2 • Up to 36 months
|
0.13%
2/1584 • Number of events 2 • Up to 36 months
|
|
Gastrointestinal disorders
ACUTE ABDOMEN
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Gastrointestinal disorders
DIARRHOEA HAEMORRHAGIC
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Gastrointestinal disorders
DIVERTICULUM INTESTINAL
|
0.00%
0/1584 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Gastrointestinal disorders
FOOD POISONING
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Gastrointestinal disorders
GASTRITIS
|
0.19%
3/1584 • Number of events 3 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/1584 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.00%
0/1584 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.19%
3/1579 • Number of events 3 • Up to 36 months
|
0.19%
3/1584 • Number of events 3 • Up to 36 months
|
|
Gastrointestinal disorders
PEPTIC ULCER
|
0.25%
4/1584 • Number of events 4 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.19%
3/1584 • Number of events 4 • Up to 36 months
|
|
Gastrointestinal disorders
PROCTITIS
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Gastrointestinal disorders
TOOTH DEVELOPMENT DISORDER
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Gastrointestinal disorders
VOLVULUS
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
General disorders
ASTHENIA
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/1584 • Up to 36 months
|
0.13%
2/1579 • Number of events 2 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Immune system disorders
ALLERGY TO ARTHROPOD STING
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Infections and infestations
ACUTE HIV INFECTION
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Infections and infestations
ANAL INFECTION
|
0.00%
0/1584 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 3 • Up to 36 months
|
|
Infections and infestations
APPENDICITIS
|
0.13%
2/1584 • Number of events 2 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Infections and infestations
BREAST ABSCESS
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Infections and infestations
BRUCELLOSIS
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Infections and infestations
CEREBRAL MALARIA
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Infections and infestations
CERVICITIS
|
0.17%
1/598 • Number of events 1 • Up to 36 months
|
0.00%
0/566 • Up to 36 months
|
0.00%
0/621 • Up to 36 months
|
|
Infections and infestations
DYSENTERY
|
0.13%
2/1584 • Number of events 2 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Infections and infestations
FEBRILE INFECTION
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.13%
2/1579 • Number of events 2 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Infections and infestations
GASTROENTERITIS
|
0.13%
2/1584 • Number of events 2 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Infections and infestations
GASTROENTERITIS SHIGELLA
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Infections and infestations
HORDEOLUM
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Infections and infestations
LOBAR PNEUMONIA
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Infections and infestations
LUNG ABSCESS
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Infections and infestations
MALARIA
|
1.8%
28/1584 • Number of events 31 • Up to 36 months
|
1.8%
28/1579 • Number of events 30 • Up to 36 months
|
2.3%
37/1584 • Number of events 40 • Up to 36 months
|
|
Infections and infestations
ORCHITIS
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Infections and infestations
PELVIC ABSCESS
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Infections and infestations
PELVIC INFLAMMATORY DISEASE
|
0.50%
3/598 • Number of events 3 • Up to 36 months
|
0.00%
0/566 • Up to 36 months
|
0.00%
0/621 • Up to 36 months
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.13%
2/1584 • Number of events 2 • Up to 36 months
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Infections and infestations
PULMONARY TUBERCULOSIS
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Infections and infestations
SALPINGITIS
|
0.00%
0/598 • Up to 36 months
|
0.00%
0/566 • Up to 36 months
|
0.16%
1/621 • Number of events 1 • Up to 36 months
|
|
Infections and infestations
SEPSIS
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Infections and infestations
TYPHOID FEVER
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.13%
2/1579 • Number of events 2 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.25%
4/1584 • Number of events 4 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Infections and infestations
WOUND INFECTION
|
0.00%
0/1584 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Injury, poisoning and procedural complications
ALCOHOL POISONING
|
0.13%
2/1584 • Number of events 2 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Injury, poisoning and procedural complications
CATARACT TRAUMATIC
|
0.00%
0/1584 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Injury, poisoning and procedural complications
CHEMICAL EYE INJURY
|
0.00%
0/1584 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Injury, poisoning and procedural complications
CHEST INJURY
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Injury, poisoning and procedural complications
CLAVICLE FRACTURE
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 2 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Injury, poisoning and procedural complications
DRUG TOXICITY
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Injury, poisoning and procedural complications
ELECTROCUTION
|
0.00%
0/1584 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Injury, poisoning and procedural complications
FALL
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Injury, poisoning and procedural complications
FIBULA FRACTURE
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Injury, poisoning and procedural complications
GUN SHOT WOUND
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.00%
0/1584 • Up to 36 months
|
0.19%
3/1579 • Number of events 3 • Up to 36 months
|
0.19%
3/1584 • Number of events 3 • Up to 36 months
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Injury, poisoning and procedural complications
INDUCED ABORTION HAEMORRHAGE
|
0.00%
0/598 • Up to 36 months
|
0.00%
0/566 • Up to 36 months
|
0.16%
1/621 • Number of events 1 • Up to 36 months
|
|
Injury, poisoning and procedural complications
INJURY
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.00%
0/1584 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.13%
2/1584 • Number of events 2 • Up to 36 months
|
|
Injury, poisoning and procedural complications
POISONING
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.32%
5/1579 • Number of events 5 • Up to 36 months
|
0.38%
6/1584 • Number of events 6 • Up to 36 months
|
|
Injury, poisoning and procedural complications
SCIATIC NERVE INJURY
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Injury, poisoning and procedural complications
SOFT TISSUE INJURY
|
0.19%
3/1584 • Number of events 3 • Up to 36 months
|
0.13%
2/1579 • Number of events 2 • Up to 36 months
|
0.19%
3/1584 • Number of events 3 • Up to 36 months
|
|
Injury, poisoning and procedural complications
STRUCK BY LIGHTNING
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Injury, poisoning and procedural complications
TENDON RUPTURE
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Injury, poisoning and procedural complications
TIBIA FRACTURE
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.19%
3/1584 • Number of events 3 • Up to 36 months
|
0.13%
2/1579 • Number of events 2 • Up to 36 months
|
0.13%
2/1584 • Number of events 2 • Up to 36 months
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.25%
4/1584 • Number of events 4 • Up to 36 months
|
0.13%
2/1579 • Number of events 2 • Up to 36 months
|
0.13%
2/1584 • Number of events 2 • Up to 36 months
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Investigations
BLOOD GLUCOSE DECREASED
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Investigations
BLOOD PHOSPHORUS DECREASED
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.32%
5/1579 • Number of events 5 • Up to 36 months
|
0.13%
2/1584 • Number of events 2 • Up to 36 months
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.82%
13/1584 • Number of events 15 • Up to 36 months
|
1.1%
18/1579 • Number of events 20 • Up to 36 months
|
0.63%
10/1584 • Number of events 10 • Up to 36 months
|
|
Investigations
PLATELET COUNT DECREASED
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.32%
5/1579 • Number of events 5 • Up to 36 months
|
0.25%
4/1584 • Number of events 5 • Up to 36 months
|
|
Investigations
WEIGHT DECREASED
|
0.00%
0/1584 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.00%
0/1584 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Metabolism and nutrition disorders
DIABETIC COMPLICATION
|
0.00%
0/1584 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
FRACTURE MALUNION
|
0.00%
0/1584 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CERVIX CARCINOMA
|
0.00%
0/598 • Up to 36 months
|
0.00%
0/566 • Up to 36 months
|
0.16%
1/621 • Number of events 1 • Up to 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OESOPHAGEAL CARCINOMA
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.00%
0/598 • Up to 36 months
|
0.18%
1/566 • Number of events 1 • Up to 36 months
|
0.00%
0/621 • Up to 36 months
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.00%
0/1584 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Nervous system disorders
CONVULSION
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Nervous system disorders
HEADACHE
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.13%
2/1584 • Number of events 2 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.00%
0/1584 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/1584 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
1.2%
7/598 • Number of events 7 • Up to 36 months
|
1.4%
8/566 • Number of events 8 • Up to 36 months
|
0.97%
6/621 • Number of events 6 • Up to 36 months
|
|
Pregnancy, puerperium and perinatal conditions
ANTEPARTUM HAEMORRHAGE
|
0.00%
0/598 • Up to 36 months
|
0.18%
1/566 • Number of events 1 • Up to 36 months
|
0.00%
0/621 • Up to 36 months
|
|
Pregnancy, puerperium and perinatal conditions
NORMAL DELIVERY
|
0.84%
5/598 • Number of events 5 • Up to 36 months
|
0.35%
2/566 • Number of events 2 • Up to 36 months
|
0.32%
2/621 • Number of events 2 • Up to 36 months
|
|
Pregnancy, puerperium and perinatal conditions
PERINEAL LACERATION
|
0.17%
1/598 • Number of events 1 • Up to 36 months
|
0.00%
0/566 • Up to 36 months
|
0.00%
0/621 • Up to 36 months
|
|
Pregnancy, puerperium and perinatal conditions
POSTPARTUM HAEMORRHAGE
|
0.00%
0/598 • Up to 36 months
|
0.00%
0/566 • Up to 36 months
|
0.16%
1/621 • Number of events 1 • Up to 36 months
|
|
Pregnancy, puerperium and perinatal conditions
PREMATURE LABOUR
|
0.17%
1/598 • Number of events 1 • Up to 36 months
|
0.00%
0/566 • Up to 36 months
|
0.16%
1/621 • Number of events 1 • Up to 36 months
|
|
Pregnancy, puerperium and perinatal conditions
PROLONGED LABOUR
|
0.00%
0/598 • Up to 36 months
|
0.18%
1/566 • Number of events 1 • Up to 36 months
|
0.00%
0/621 • Up to 36 months
|
|
Psychiatric disorders
ACUTE PSYCHOSIS
|
0.00%
0/1584 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Psychiatric disorders
COMPLETED SUICIDE
|
0.00%
0/1584 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Psychiatric disorders
SCHIZOPHRENIA
|
0.00%
0/1584 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.13%
2/1579 • Number of events 2 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Renal and urinary disorders
ACUTE PRERENAL FAILURE
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.10%
1/986 • Number of events 1 • Up to 36 months
|
0.10%
1/1013 • Number of events 1 • Up to 36 months
|
0.00%
0/963 • Up to 36 months
|
|
Reproductive system and breast disorders
CERVIX DISORDER
|
0.17%
1/598 • Number of events 1 • Up to 36 months
|
0.00%
0/566 • Up to 36 months
|
0.00%
0/621 • Up to 36 months
|
|
Reproductive system and breast disorders
FALLOPIAN TUBE CYST
|
0.00%
0/598 • Up to 36 months
|
0.00%
0/566 • Up to 36 months
|
0.16%
1/621 • Number of events 1 • Up to 36 months
|
|
Reproductive system and breast disorders
METRORRHAGIA
|
0.17%
1/598 • Number of events 1 • Up to 36 months
|
0.00%
0/566 • Up to 36 months
|
0.00%
0/621 • Up to 36 months
|
|
Reproductive system and breast disorders
OVARIAN CYST
|
0.00%
0/598 • Up to 36 months
|
0.18%
1/566 • Number of events 1 • Up to 36 months
|
0.16%
1/621 • Number of events 1 • Up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
PLEURISY
|
0.00%
0/1584 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
SCAR PAIN
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Social circumstances
VICTIM OF CRIME
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
|
Surgical and medical procedures
COLOSTOMY
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/1584 • Up to 36 months
|
0.06%
1/1579 • Number of events 1 • Up to 36 months
|
0.00%
0/1584 • Up to 36 months
|
|
Vascular disorders
HYPOTENSION
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
0.00%
0/1579 • Up to 36 months
|
0.06%
1/1584 • Number of events 1 • Up to 36 months
|
Other adverse events
| Measure |
Tenofovir Disoproxil Fumarate (TDF)
n=1584 participants at risk
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
|
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
n=1579 participants at risk
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
|
Placebo
n=1584 participants at risk
Placebo TDF \& Placebo FTC/TDF, 1 tablet each daily.
|
|---|---|---|---|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
37.8%
598/1584 • Number of events 1109 • Up to 36 months
|
43.4%
686/1579 • Number of events 1322 • Up to 36 months
|
36.4%
577/1584 • Number of events 1076 • Up to 36 months
|
|
Investigations
BLOOD PHOSPHORUS DECREASED
|
27.8%
440/1584 • Number of events 763 • Up to 36 months
|
29.1%
460/1579 • Number of events 785 • Up to 36 months
|
29.9%
473/1584 • Number of events 787 • Up to 36 months
|
|
Infections and infestations
MALARIA
|
18.3%
290/1584 • Number of events 371 • Up to 36 months
|
16.9%
267/1579 • Number of events 356 • Up to 36 months
|
17.7%
280/1584 • Number of events 352 • Up to 36 months
|
|
Investigations
HAEMOGLOBIN DECREASED
|
16.4%
259/1584 • Number of events 384 • Up to 36 months
|
14.6%
230/1579 • Number of events 335 • Up to 36 months
|
14.6%
231/1584 • Number of events 331 • Up to 36 months
|
|
Investigations
PLATELET COUNT DECREASED
|
12.0%
190/1584 • Number of events 306 • Up to 36 months
|
11.9%
188/1579 • Number of events 305 • Up to 36 months
|
11.2%
177/1584 • Number of events 298 • Up to 36 months
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
7.9%
125/1584 • Number of events 147 • Up to 36 months
|
10.1%
159/1579 • Number of events 189 • Up to 36 months
|
9.0%
142/1584 • Number of events 169 • Up to 36 months
|
|
Investigations
BLOOD BICARBONATE DECREASED
|
7.8%
123/1584 • Number of events 142 • Up to 36 months
|
7.5%
118/1579 • Number of events 130 • Up to 36 months
|
8.5%
135/1584 • Number of events 148 • Up to 36 months
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
6.8%
108/1584 • Number of events 117 • Up to 36 months
|
5.8%
91/1579 • Number of events 107 • Up to 36 months
|
7.2%
114/1584 • Number of events 133 • Up to 36 months
|
|
Infections and infestations
URINARY TRACT INFECTION
|
6.6%
105/1584 • Number of events 121 • Up to 36 months
|
5.4%
86/1579 • Number of events 96 • Up to 36 months
|
6.5%
103/1584 • Number of events 122 • Up to 36 months
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
5.9%
93/1584 • Number of events 138 • Up to 36 months
|
6.5%
103/1579 • Number of events 146 • Up to 36 months
|
6.1%
96/1584 • Number of events 124 • Up to 36 months
|
|
Investigations
BLOOD CREATININE INCREASED
|
4.8%
76/1584 • Number of events 99 • Up to 36 months
|
6.8%
107/1579 • Number of events 126 • Up to 36 months
|
5.4%
86/1584 • Number of events 108 • Up to 36 months
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
5.7%
90/1584 • Number of events 103 • Up to 36 months
|
5.5%
87/1579 • Number of events 104 • Up to 36 months
|
4.6%
73/1584 • Number of events 85 • Up to 36 months
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
3.2%
50/1584 • Number of events 59 • Up to 36 months
|
4.5%
71/1579 • Number of events 93 • Up to 36 months
|
4.0%
64/1584 • Number of events 83 • Up to 36 months
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
3.5%
56/1584 • Number of events 82 • Up to 36 months
|
3.1%
49/1579 • Number of events 64 • Up to 36 months
|
4.0%
63/1584 • Number of events 88 • Up to 36 months
|
|
Infections and infestations
PELVIC INFLAMMATORY DISEASE
|
9.9%
59/598 • Number of events 71 • Up to 36 months
|
8.5%
48/566 • Number of events 55 • Up to 36 months
|
8.9%
55/621 • Number of events 62 • Up to 36 months
|
|
Gastrointestinal disorders
DIARRHOEA
|
3.0%
48/1584 • Number of events 56 • Up to 36 months
|
2.3%
37/1579 • Number of events 39 • Up to 36 months
|
2.5%
39/1584 • Number of events 41 • Up to 36 months
|
|
Renal and urinary disorders
PROTEINURIA
|
2.5%
40/1584 • Number of events 47 • Up to 36 months
|
2.3%
36/1579 • Number of events 46 • Up to 36 months
|
2.1%
34/1584 • Number of events 43 • Up to 36 months
|
|
Infections and infestations
GASTROENTERITIS
|
2.1%
33/1584 • Number of events 36 • Up to 36 months
|
2.0%
32/1579 • Number of events 34 • Up to 36 months
|
1.9%
30/1584 • Number of events 32 • Up to 36 months
|
|
Reproductive system and breast disorders
GENITAL ULCERATION
|
1.6%
26/1584 • Number of events 29 • Up to 36 months
|
2.2%
35/1579 • Number of events 48 • Up to 36 months
|
2.1%
34/1584 • Number of events 38 • Up to 36 months
|
|
Infections and infestations
TYPHOID FEVER
|
2.0%
32/1584 • Number of events 39 • Up to 36 months
|
1.8%
28/1579 • Number of events 31 • Up to 36 months
|
1.5%
23/1584 • Number of events 24 • Up to 36 months
|
|
Infections and infestations
SYPHILIS
|
1.8%
28/1584 • Number of events 30 • Up to 36 months
|
1.7%
27/1579 • Number of events 31 • Up to 36 months
|
1.5%
23/1584 • Number of events 24 • Up to 36 months
|
|
Gastrointestinal disorders
GASTRITIS
|
1.3%
20/1584 • Number of events 22 • Up to 36 months
|
1.8%
28/1579 • Number of events 31 • Up to 36 months
|
1.5%
24/1584 • Number of events 28 • Up to 36 months
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.5%
23/1584 • Number of events 23 • Up to 36 months
|
1.4%
22/1579 • Number of events 23 • Up to 36 months
|
1.5%
24/1584 • Number of events 24 • Up to 36 months
|
|
Infections and infestations
CELLULITIS
|
1.6%
26/1584 • Number of events 27 • Up to 36 months
|
0.76%
12/1579 • Number of events 13 • Up to 36 months
|
1.6%
26/1584 • Number of events 27 • Up to 36 months
|
|
Vascular disorders
HYPERTENSION
|
1.2%
19/1584 • Number of events 20 • Up to 36 months
|
0.89%
14/1579 • Number of events 18 • Up to 36 months
|
1.9%
30/1584 • Number of events 42 • Up to 36 months
|
|
Infections and infestations
URETHRITIS
|
1.6%
26/1584 • Number of events 33 • Up to 36 months
|
1.0%
16/1579 • Number of events 16 • Up to 36 months
|
1.3%
20/1584 • Number of events 22 • Up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
0.88%
14/1584 • Number of events 14 • Up to 36 months
|
1.2%
19/1579 • Number of events 19 • Up to 36 months
|
1.7%
27/1584 • Number of events 28 • Up to 36 months
|
|
Renal and urinary disorders
URETHRAL DISCHARGE
|
1.1%
17/1584 • Number of events 20 • Up to 36 months
|
1.3%
21/1579 • Number of events 23 • Up to 36 months
|
1.1%
18/1584 • Number of events 22 • Up to 36 months
|
|
Infections and infestations
PNEUMONIA
|
1.0%
16/1584 • Number of events 17 • Up to 36 months
|
1.1%
17/1579 • Number of events 19 • Up to 36 months
|
1.3%
21/1584 • Number of events 23 • Up to 36 months
|
|
Injury, poisoning and procedural complications
SOFT TISSUE INJURY
|
1.1%
18/1584 • Number of events 18 • Up to 36 months
|
1.2%
19/1579 • Number of events 19 • Up to 36 months
|
1.0%
16/1584 • Number of events 17 • Up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
1.4%
22/1584 • Number of events 25 • Up to 36 months
|
1.3%
20/1579 • Number of events 21 • Up to 36 months
|
0.69%
11/1584 • Number of events 12 • Up to 36 months
|
|
Infections and infestations
PHARYNGITIS
|
1.0%
16/1584 • Number of events 16 • Up to 36 months
|
1.1%
18/1579 • Number of events 18 • Up to 36 months
|
0.95%
15/1584 • Number of events 15 • Up to 36 months
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
2.2%
13/598 • Number of events 14 • Up to 36 months
|
3.4%
19/566 • Number of events 20 • Up to 36 months
|
2.7%
17/621 • Number of events 17 • Up to 36 months
|
|
Gastrointestinal disorders
DIARRHOEA HAEMORRHAGIC
|
1.1%
17/1584 • Number of events 17 • Up to 36 months
|
1.0%
16/1579 • Number of events 16 • Up to 36 months
|
0.95%
15/1584 • Number of events 17 • Up to 36 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place