Trial Outcomes & Findings for Time to Protection and Adherence Requirements of Raltegravir With or Without Lamivudine in Protection From HIV Infection (NCT NCT03205566)
NCT ID: NCT03205566
Last Updated: 2021-03-16
Results Overview
The level of Raltegravir alone or Raltegravir /lamivudine required in the plasma, vagina and rectum for 100% ex vivo protection from HIV . High viral dose challenge: ex vivo challenge of tissue with 104 TCID50/mL HIV-1BaL Low viral dose challenge: ex vivo challenge of tissue with 102 TCID50/mL HIV-1BaL
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
38 participants
Primary outcome timeframe
Through Study completion, an average of 55 days
Results posted on
2021-03-16
Participant Flow
Potential participants were identified via study poster, internal recruitment emails, and via a list of individuals who had consented to be contacted for further research. Potential participants would contact the team, trial discussed \& information sheet provided. If still interested, would be consented and screening visit booked.
Once participants were consented to the study, they undertook a screening visits to confirm eligibility. If eligibility was not confirmed, the participant was deemed a screen failure and not randomised to the trial.
Participant milestones
| Measure |
Raltegravir, Then Raltegravir/Lamivudine
Raltegravir 400mg tablet, taken twice a day for 7days.
Washout minimum of 28 days
Raltegravir 400mg plus lamivudine 150mg taken twice a day for 7 days
|
Raltegravir Lamivudine, Then Raltegravir
Raltegravir 400mg + Lamivudine 150mg tablet, taken twice a day for 7days.
Washout minimum 28 days
Raltegravir 400Mg Tab: bd for 7 days
|
|---|---|---|
|
Phase 1
STARTED
|
19
|
19
|
|
Phase 1
COMPLETED
|
18
|
18
|
|
Phase 1
NOT COMPLETED
|
1
|
1
|
|
Phase 2
STARTED
|
18
|
18
|
|
Phase 2
COMPLETED
|
18
|
18
|
|
Phase 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Raltegravir, Then Raltegravir/Lamivudine
Raltegravir 400mg tablet, taken twice a day for 7days.
Washout minimum of 28 days
Raltegravir 400mg plus lamivudine 150mg taken twice a day for 7 days
|
Raltegravir Lamivudine, Then Raltegravir
Raltegravir 400mg + Lamivudine 150mg tablet, taken twice a day for 7days.
Washout minimum 28 days
Raltegravir 400Mg Tab: bd for 7 days
|
|---|---|---|
|
Phase 1
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Time to Protection and Adherence Requirements of Raltegravir With or Without Lamivudine in Protection From HIV Infection
Baseline characteristics by cohort
| Measure |
Raltegravir, Then Raltegravir Plus Lamivudine
n=19 Participants
Raltegravir 400mg tablet, taken twice a day for 7days.
Washout period 28 days
Raltegravir 400mg + Lamivudine 150mg tablet, taken twice a day for 7days.
|
Raltegravir Lamivudine, Then Raltegravir
n=19 Participants
Raltegravir 400mg + Lamivudine 150mg tablet, taken twice a day for 7days.
Washout period 28 days
Raltegravir 400Mg Tab: bd for 7 days
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
26.9 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
30.9 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
29 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through Study completion, an average of 55 daysPopulation: Excludes two participants who were withdrawn from the study due to not meeting study inclusion criteria, but who were nonetheless included in safety analyses as they received at least one dose of study medication
The level of Raltegravir alone or Raltegravir /lamivudine required in the plasma, vagina and rectum for 100% ex vivo protection from HIV . High viral dose challenge: ex vivo challenge of tissue with 104 TCID50/mL HIV-1BaL Low viral dose challenge: ex vivo challenge of tissue with 102 TCID50/mL HIV-1BaL
Outcome measures
| Measure |
Raltegravir
n=36 Participants
Raltegravir 400mg tablet, taken twice a day for 7days.
Raltegravir 400Mg Tab: bd for 7 days
|
Raltegravir During Combination Treatment
n=36 Participants
Raltegravir 400mg + Lamivudine 150mg tablet, taken twice a day for 7days.
Raltegravir 400Mg Tab: bd for 7 days
Lamivudine 150Mg Tablet: + Raltegravir 400Mg tablet bd for 7 days
|
Lamivudine During Combination Treatment
n=36 Participants
Raltegravir 400mg + Lamivudine 150mg tablet, taken twice a day for 7days.
Raltegravir 400Mg Tab: bd for 7 days
Lamivudine 150Mg Tablet: + Raltegravir 400Mg tablet bd for 7 days
|
|---|---|---|---|
|
The Level of Raltegravir Alone or Raltegravir /Lamivudine Required in the Plasma, Vagina and Rectum for 100% ex Vivo Protection From HIV
Plasma: High Dose Challenge in rectal tissue
|
NA ng/mL
Standard Error NA
Samples were below detection level for primary outcome
|
669.90 ng/mL
Standard Error 231.40
|
265.10 ng/mL
Standard Error 76.50
|
|
The Level of Raltegravir Alone or Raltegravir /Lamivudine Required in the Plasma, Vagina and Rectum for 100% ex Vivo Protection From HIV
Plasma: Low viral dose challenge in rectal tissue
|
979.8 ng/mL
Standard Error 306.5
|
669.90 ng/mL
Standard Error 231.40
|
265.10 ng/mL
Standard Error 76.50
|
|
The Level of Raltegravir Alone or Raltegravir /Lamivudine Required in the Plasma, Vagina and Rectum for 100% ex Vivo Protection From HIV
Rectal: high viral dose challenge in rectal tissue
|
NA ng/mL
Standard Error NA
Samples were below detection level for primary outcome
|
862.35 ng/mL
Standard Error 237.60
|
1722.02 ng/mL
Standard Error 235.10
|
|
The Level of Raltegravir Alone or Raltegravir /Lamivudine Required in the Plasma, Vagina and Rectum for 100% ex Vivo Protection From HIV
Rectal: Low viral dose challenge in rectal tissue
|
729.36 ng/mL
Standard Error 218.10
|
862.35 ng/mL
Standard Error 237.60
|
1722.02 ng/mL
Standard Error 235.10
|
|
The Level of Raltegravir Alone or Raltegravir /Lamivudine Required in the Plasma, Vagina and Rectum for 100% ex Vivo Protection From HIV
Plasma: high viral dose challenge in vaginal tissu
|
NA ng/mL
Standard Error NA
Samples were below detection level for primary outcome
|
828.60 ng/mL
Standard Error 510.30
|
266.40 ng/mL
Standard Error 101.60
|
|
The Level of Raltegravir Alone or Raltegravir /Lamivudine Required in the Plasma, Vagina and Rectum for 100% ex Vivo Protection From HIV
Plasma: low viral dose challenge in vaginal tissue
|
979.8 ng/mL
Standard Error 306.5
|
281.60 ng/mL
Standard Error 99.10
|
169.10 ng/mL
Standard Error 19.30
|
|
The Level of Raltegravir Alone or Raltegravir /Lamivudine Required in the Plasma, Vagina and Rectum for 100% ex Vivo Protection From HIV
Plasma: high dose in vaginal tissue
|
NA ng/mL
Standard Error NA
Samples were below detection level for primary outcome
|
648.24 ng/mL
Standard Error 432.90
|
1557.80 ng/mL
Standard Error 206.30
|
|
The Level of Raltegravir Alone or Raltegravir /Lamivudine Required in the Plasma, Vagina and Rectum for 100% ex Vivo Protection From HIV
Plasma: low dose in vaginal tissue
|
607.60 ng/mL
Standard Error 157.28
|
273.02 ng/mL
Standard Error 88.40
|
1437.80 ng/mL
Standard Error 133.30
|
SECONDARY outcome
Timeframe: Up to 7 days from first dosePopulation: Excludes two participants who were withdrawn from the study due to not meeting study inclusion criteria, but who were nonetheless included in safety analyses as they received at least one dose of study medication
Time in days from first receipt of antiretroviral (Raltegravir 400mg +/-lamivudine) until maximal ex vivo protection (against high or low titre of HIV-1BaL) was observed.
Outcome measures
| Measure |
Raltegravir
n=36 Participants
Raltegravir 400mg tablet, taken twice a day for 7days.
Raltegravir 400Mg Tab: bd for 7 days
|
Raltegravir During Combination Treatment
n=36 Participants
Raltegravir 400mg + Lamivudine 150mg tablet, taken twice a day for 7days.
Raltegravir 400Mg Tab: bd for 7 days
Lamivudine 150Mg Tablet: + Raltegravir 400Mg tablet bd for 7 days
|
Lamivudine During Combination Treatment
Raltegravir 400mg + Lamivudine 150mg tablet, taken twice a day for 7days.
Raltegravir 400Mg Tab: bd for 7 days
Lamivudine 150Mg Tablet: + Raltegravir 400Mg tablet bd for 7 days
|
|---|---|---|---|
|
The Time From First Dose of Drug to Maximum Mucosal ex Vivo Protection From HIV.
Time from first dose of drug to maximum rectal ex vivo protection from high titer HIV infection
|
3 Days
Standard Error 0.58
|
2 Days
Standard Error 0
|
—
|
|
The Time From First Dose of Drug to Maximum Mucosal ex Vivo Protection From HIV.
Time from first dose of drug to maximum rectal ex vivo protection from low titer HIV infection
|
2 Days
Standard Error 0
|
2 Days
Standard Error 0
|
—
|
|
The Time From First Dose of Drug to Maximum Mucosal ex Vivo Protection From HIV.
Time from first dose of drug to maximum rectal ex vivo protection from High titer HIV infection
|
2.67 Days
Standard Error 0.67
|
3 Days
Standard Error 0.68
|
—
|
|
The Time From First Dose of Drug to Maximum Mucosal ex Vivo Protection From HIV.
Time from first dose of drug to maximum vaginal ex vivo protection from low titer HIV infection
|
3 Days
Standard Error 0.45
|
3.67 Days
Standard Error 0.61
|
—
|
SECONDARY outcome
Timeframe: Through Study completion, an average of 55 daysPopulation: Includes two participants who were withdrawn from the study due to not meeting study inclusion criteria, but who were nonetheless included in safety analyses as they received at least one dose of study medication
Subject safety and tolerability will be determined by physical examination, blood tests and adverse event reporting. FBC, U\&E and LFTs will be carried out at baseline and thereafter as symptom directed. Adverse event review. If significant adverse events have been reported, these will be clinically followed in accordance to the instruction of the study physician.
Outcome measures
| Measure |
Raltegravir
n=38 Participants
Raltegravir 400mg tablet, taken twice a day for 7days.
Raltegravir 400Mg Tab: bd for 7 days
|
Raltegravir During Combination Treatment
n=38 Participants
Raltegravir 400mg + Lamivudine 150mg tablet, taken twice a day for 7days.
Raltegravir 400Mg Tab: bd for 7 days
Lamivudine 150Mg Tablet: + Raltegravir 400Mg tablet bd for 7 days
|
Lamivudine During Combination Treatment
Raltegravir 400mg + Lamivudine 150mg tablet, taken twice a day for 7days.
Raltegravir 400Mg Tab: bd for 7 days
Lamivudine 150Mg Tablet: + Raltegravir 400Mg tablet bd for 7 days
|
|---|---|---|---|
|
Number of Adverse Events Based on PE, Blood Test and Event Reporting on Raltegravir Based PrEP, in HIV Negative Individuals
|
12 Adverse event
|
15 Adverse event
|
—
|
SECONDARY outcome
Timeframe: 5 days post last dosePopulation: Excludes two participants who were withdrawn from the study due to not meeting study inclusion criteria, but who were nonetheless included in safety analyses as they received at least one dose of study medication
Time in days from stopping antiretroviral (Raltegravir 400mg +/-lamivudine) until ex vivo protection (against high or low viral titre of HIV-1BaL) was no longer observed.
Outcome measures
| Measure |
Raltegravir
n=36 Participants
Raltegravir 400mg tablet, taken twice a day for 7days.
Raltegravir 400Mg Tab: bd for 7 days
|
Raltegravir During Combination Treatment
n=36 Participants
Raltegravir 400mg + Lamivudine 150mg tablet, taken twice a day for 7days.
Raltegravir 400Mg Tab: bd for 7 days
Lamivudine 150Mg Tablet: + Raltegravir 400Mg tablet bd for 7 days
|
Lamivudine During Combination Treatment
Raltegravir 400mg + Lamivudine 150mg tablet, taken twice a day for 7days.
Raltegravir 400Mg Tab: bd for 7 days
Lamivudine 150Mg Tablet: + Raltegravir 400Mg tablet bd for 7 days
|
|---|---|---|---|
|
The Time to Cessation of Mucosal ex Vivo Protection From HIV After Stopping ART at Steady State.
Time to cessation of rectal ex vivo protection from high HIV dose challenge post ART at steady state
|
3.33 Days
Standard Error 0.69
|
NA Days
Standard Error NA
Cessation of mucosal ex vivo protection from HIV was not reached by the end of the follow up period (5 days), therefore mean and standard error could not be calculated.
|
—
|
|
The Time to Cessation of Mucosal ex Vivo Protection From HIV After Stopping ART at Steady State.
Time to cessation of rectal ex vivo protection from low HIV dose challenge post ART at steady state
|
NA Days
Standard Error NA
Cessation of mucosal ex vivo protection from HIV was not reached by the end of the follow up period (5 days), therefore mean and standard error could not be calculated.
|
NA Days
Standard Error NA
Cessation of mucosal ex vivo protection from HIV was not reached by the end of the follow up period (5 days), therefore mean and standard error could not be calculated.
|
—
|
|
The Time to Cessation of Mucosal ex Vivo Protection From HIV After Stopping ART at Steady State.
Time to cessation of vaginal ex vivo protection from high HIVdose challenge post ART at steady state
|
4 Days
Standard Error 1.13
|
NA Days
Standard Error NA
Cessation of mucosal ex vivo protection from HIV was not reached by the end of the follow up period (5 days), therefore mean and standard error could not be calculated.
|
—
|
|
The Time to Cessation of Mucosal ex Vivo Protection From HIV After Stopping ART at Steady State.
Time to cessation of vaginal ex vivo protection from low HIV dose challenge post ART at steady state
|
5 Days
Standard Error 1.26
|
NA Days
Standard Error NA
Cessation of mucosal ex vivo protection from HIV was not reached by the end of the follow up period (5 days), therefore mean and standard error could not be calculated.
|
—
|
Adverse Events
Arm A Raltegravir
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Arm B Raltegravir Lamivudine
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A Raltegravir
n=38 participants at risk
Raltegravir 400mg tablet, taken twice a day for 7days.
Raltegravir 400Mg Tab: bd for 7 days
|
Arm B Raltegravir Lamivudine
n=38 participants at risk
Raltegravir 400mg + Lamivudine 150mg tablet, taken twice a day for 7days.
Raltegravir 400Mg Tab: bd for 7 days
Lamivudine 150Mg Tablet: + Raltegravir 400Mg tablet bd for 7 days
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Painful left toe
|
2.6%
1/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
2.6%
1/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Infections and infestations
Viral illness with abdominal pain, vomiting, nausea, fever
|
2.6%
1/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
0.00%
0/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Nervous system disorders
Headache
|
2.6%
1/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
7.9%
3/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Respiratory, thoracic and mediastinal disorders
Runny nose
|
10.5%
4/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
0.00%
0/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Blood and lymphatic system disorders
Abnormal LFTs
|
2.6%
1/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
0.00%
0/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Gastrointestinal disorders
Acid Reflux
|
0.00%
0/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
2.6%
1/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
General disorders
Chills
|
0.00%
0/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
2.6%
1/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
5.3%
2/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
0.00%
0/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
1/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
0.00%
0/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
General disorders
Dehydration
|
2.6%
1/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
0.00%
0/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
2/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
7.9%
3/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Nervous system disorders
Dizziness
|
0.00%
0/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
2.6%
1/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
General disorders
Fatigue
|
5.3%
2/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
2.6%
1/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Infections and infestations
Fever
|
0.00%
0/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
5.3%
2/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Infections and infestations
Flu
|
2.6%
1/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
0.00%
0/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Injury, poisoning and procedural complications
Fluoxetine Overdose
|
0.00%
0/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
2.6%
1/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
0.00%
0/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
2.6%
1/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Gastrointestinal disorders
Impacted tooth
|
0.00%
0/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
2.6%
1/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
2.6%
1/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Nervous system disorders
Light headedness
|
0.00%
0/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
2.6%
1/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Gastrointestinal disorders
Loose Stool
|
0.00%
0/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
5.3%
2/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
0.00%
0/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Blood and lymphatic system disorders
Neck lump right side
|
0.00%
0/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
2.6%
1/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Psychiatric disorders
Nightmares and vivid dreams
|
0.00%
0/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
13.2%
5/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Respiratory, thoracic and mediastinal disorders
Nose bleed
|
0.00%
0/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
2.6%
1/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Perianal lump
|
2.6%
1/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
2.6%
1/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
General disorders
Rectal Pain
|
2.6%
1/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
0.00%
0/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Investigations
Rectal Discomfort and PR bleeding
|
0.00%
0/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
2.6%
1/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Psychiatric disorders
Sleep disturbance
|
0.00%
0/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
2.6%
1/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
5.3%
2/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
0.00%
0/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Vascular disorders
Spotting
|
0.00%
0/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
5.3%
2/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Blood and lymphatic system disorders
Swollen neck glands
|
2.6%
1/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
2.6%
1/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
|
Infections and infestations
Tonsillitis
|
5.3%
2/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
0.00%
0/38 • Adverse event data was collected for the duration each subject participated in the trial, this being from enrollment to final visit, which is approximately 55 days.
All adverse event data that was captured as part of trial participation, including that of individuals withdrawn from the trial, were used in analysis
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place