Trial Outcomes & Findings for Oligonucleotide Ligation Assay (OLA) Resistance Study (NCT NCT01898754)
NCT ID: NCT01898754
Last Updated: 2025-03-12
Results Overview
The primary endpoint will be a comparison of the rates of viral non-suppression \>400 copies/mL between study arms at 12 months
COMPLETED
NA
991 participants
12 months
2025-03-12
Participant Flow
Participant milestones
| Measure |
Pre-ART Oligonucleotide Assay (OLA)
Pre-ART OLA will be tested for resistance at 5 pol codons conferring high-level resistance to NNRTI and 3TC (K103N, V106M, Y181C, G190A and M184V)
Pre-ART Oligonucleotide Assay (OLA): Block randomization (1:1) to pre-ART OLA testing or OLA testing after 12mo on ART
|
No OLA (Standard of Care [SOC])
The participants will receive standard of care as per Kenya guidelines but will be offered OLA resistance testing after 12 months
|
|---|---|---|
|
Overall Study
STARTED
|
494
|
497
|
|
Overall Study
Received OLA or SOC as Randomly Assigned
|
492
|
495
|
|
Overall Study
COMPLETED
|
400
|
403
|
|
Overall Study
NOT COMPLETED
|
94
|
94
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oligonucleotide Ligation Assay (OLA) Resistance Study
Baseline characteristics by cohort
| Measure |
Pre-ART Oligonucleotide Assay (OLA)
n=492 Participants
Pre-ART OLA will be tested for resistance at 5 pol codons conferring high-level resistance to NNRTI and 3TC (K103N, V106M, Y181C, G190A and M184V)
Pre-ART Oligonucleotide Assay (OLA): Block randomization (1:1) to pre-ART OLA testing or OLA testing after 12mo on ART
|
No OLA (Standard of Care [SOC])
n=495 Participants
The participants will receive standard of care as per Kenya guidelines but will be offered OLA resistance testing after 12 months
|
Total
n=987 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38 years
n=99 Participants
|
37 years
n=107 Participants
|
37 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
320 Participants
n=99 Participants
|
321 Participants
n=107 Participants
|
641 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
172 Participants
n=99 Participants
|
174 Participants
n=107 Participants
|
346 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
492 Participants
n=99 Participants
|
495 Participants
n=107 Participants
|
987 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Kenya
|
492 participants
n=99 Participants
|
495 participants
n=107 Participants
|
987 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe primary endpoint will be a comparison of the rates of viral non-suppression \>400 copies/mL between study arms at 12 months
Outcome measures
| Measure |
Pre-ART Oligonucleotide Assay (OLA)
n=400 Participants
Pre-ART OLA will be tested for resistance at 5 pol codons conferring high-level resistance to NNRTI and 3TC (K103N, V106M, Y181C, G190A and M184V)
Pre-ART Oligonucleotide Assay (OLA): Block randomization (1:1) to pre-ART OLA testing or OLA testing after 12mo on ART
|
No OLA (Standard of Care [SOC])
n=403 Participants
The participants will receive standard of care as per Kenya guidelines but will be offered OLA resistance testing after 12 months
|
|---|---|---|
|
Number of Participants With Virologic Failure With OLA-guided ART vs. Standard of Care
|
34 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: 15 monthsPopulation: WHO defines pretreatment HIV drug resistance (PDR) as "DR that is detected in ARV drug-naive people initiating ART or people with prior ARV drug exposure initiating or reinitiating first-line ART. PDR is either transmitted or acquired drug resistance, or both". Thus, we did not report outcomes with TDR, instead we reported PDR as this could be determined but antiretroviral history was not available. Thus, PDR is reported in place of TDR. This included participants with PDR ≥10% at randomization.
We did not analyze and report outcome of people with TDR ≥10%, instead we reported pretreatment drug resistance (PDR) as this parameter could be determined but antiretroviral history was not reliably available. Thus, PDR ≥10% is considered below in place of TDR ≥10%. Chung et al. Lancet HIV 2020; 7: e104-12.
Outcome measures
| Measure |
Pre-ART Oligonucleotide Assay (OLA)
n=35 Participants
Pre-ART OLA will be tested for resistance at 5 pol codons conferring high-level resistance to NNRTI and 3TC (K103N, V106M, Y181C, G190A and M184V)
Pre-ART Oligonucleotide Assay (OLA): Block randomization (1:1) to pre-ART OLA testing or OLA testing after 12mo on ART
|
No OLA (Standard of Care [SOC])
n=26 Participants
The participants will receive standard of care as per Kenya guidelines but will be offered OLA resistance testing after 12 months
|
|---|---|---|
|
The Difference in Virologic Failure Among Participants With Transmitted Drug-resistance (TDR) ≥10% Associated With Use of OLA-guided ART vs. SOC
Participants with PDR and virologic failure
|
5 Participants
|
13 Participants
|
|
The Difference in Virologic Failure Among Participants With Transmitted Drug-resistance (TDR) ≥10% Associated With Use of OLA-guided ART vs. SOC
Participants with PDR and no virologic failure
|
30 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 15 monthsPopulation: The analysis population included only those participants that had prior or ongoing ART use (non-ARV naive) at randomization.
The primary outcome was virologic failure defined as plasma HIV RNA of at least 400 copies per mL after initiation of antiretroviral therapy (ART).
Outcome measures
| Measure |
Pre-ART Oligonucleotide Assay (OLA)
n=32 Participants
Pre-ART OLA will be tested for resistance at 5 pol codons conferring high-level resistance to NNRTI and 3TC (K103N, V106M, Y181C, G190A and M184V)
Pre-ART Oligonucleotide Assay (OLA): Block randomization (1:1) to pre-ART OLA testing or OLA testing after 12mo on ART
|
No OLA (Standard of Care [SOC])
n=32 Participants
The participants will receive standard of care as per Kenya guidelines but will be offered OLA resistance testing after 12 months
|
|---|---|---|
|
Difference in Virologic Failure in the Subgroup of Participants With Prior or Ongoing ART Use Associated With Use of OLA-guided ART vs. SOC
Participants with pre-ART and virologic failure
|
1 Participants
|
1 Participants
|
|
Difference in Virologic Failure in the Subgroup of Participants With Prior or Ongoing ART Use Associated With Use of OLA-guided ART vs. SOC
Participants with pre-ART and no virologic failure
|
31 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 15 monthsPopulation: WHO defines pretreatment HIV drug resistance (PDR) as "DR that is detected in ARV drug-naive people initiating ART or people with prior ARV drug exposure initiating or reinitiating first-line ART". Thus, we did not report outcomes with TDR, instead we reported PDR as this could be determined but antiretroviral history was not available. Thus, PDR is reported in place of TDR. This analysis included participants with PDR assessed by OLA and confirmed by consensus sequencing by study arm.
We did not analyze and report outcome of people with TDR, instead we reported pretreatment drug resistance (PDR) as this parameter could be determined but antiretroviral history was not reliably available. Thus, PDR is considered below in place of TDR. PDR was assessed by OLA and confirmed by consensus sequence or next-generation sequencing.
Outcome measures
| Measure |
Pre-ART Oligonucleotide Assay (OLA)
n=492 Participants
Pre-ART OLA will be tested for resistance at 5 pol codons conferring high-level resistance to NNRTI and 3TC (K103N, V106M, Y181C, G190A and M184V)
Pre-ART Oligonucleotide Assay (OLA): Block randomization (1:1) to pre-ART OLA testing or OLA testing after 12mo on ART
|
No OLA (Standard of Care [SOC])
n=495 Participants
The participants will receive standard of care as per Kenya guidelines but will be offered OLA resistance testing after 12 months
|
|---|---|---|
|
Prevalence of TDR by Consensus Sequencing and OLA
Participants without PDR
|
441 Participants
|
453 Participants
|
|
Prevalence of TDR by Consensus Sequencing and OLA
Participants with PDR
|
51 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: 15 monthsPopulation: WHO defines pretreatment HIV drug resistance (PDR) as "DR that is detected in ARV drug-naive people initiating ART or people with prior ARV drug exposure initiating or reinitiating first-line ART". Thus, we did not report outcomes with TDR, instead we reported PDR as this could be determined but antiretroviral history was not available. Thus, PDR is reported in place of TDR. The population included the subgroup of participants with PDR in each study arm.
We did not analyze and report outcome of people with TDR, instead we reported pretreatment drug resistance (PDR) as this parameter could be determined but antiretroviral history was not reliably available. Thus, PDR is considered below in place of TDR. The primary outcome for this analysis was the difference in virologic failure, defined as plasma HIV-1 RNA of at least 400 copies per mL following ART initiation, by PDR. \[Chung et al. Lancet HIV 2020; 7: e104-12\]
Outcome measures
| Measure |
Pre-ART Oligonucleotide Assay (OLA)
n=35 Participants
Pre-ART OLA will be tested for resistance at 5 pol codons conferring high-level resistance to NNRTI and 3TC (K103N, V106M, Y181C, G190A and M184V)
Pre-ART Oligonucleotide Assay (OLA): Block randomization (1:1) to pre-ART OLA testing or OLA testing after 12mo on ART
|
No OLA (Standard of Care [SOC])
n=26 Participants
The participants will receive standard of care as per Kenya guidelines but will be offered OLA resistance testing after 12 months
|
|---|---|---|
|
Proportion of Subgroup With TDR With Virologic Failure by Randomization Arm
Participants with PDR and virologic failure
|
5 Participants
|
13 Participants
|
|
Proportion of Subgroup With TDR With Virologic Failure by Randomization Arm
Participants with PDR and no virologic failure
|
30 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 15 monthsPopulation: No data available (data on medical resource utilization was not collected).
Estimates of medical resource utilization during was not calculated. No data available (data on medical resource utilization was not collected during the one-year trial)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 15 monthsPopulation: This was not calculated as the model could not test for a period longer than 15 years due to computing limitations.
This was not calculated as the model could not test for a period longer than 15 years due to computing limitations.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsPopulation: Analysis included 352 participants from Nairobi, including 332 with virologic suppression at month-12 of efavirenz-based ART who enrolled for a second year and 20 participants who experienced virologic failure by month-12 of efavirenz-based ART. Pretreatment drug-resistance was classified as: wild-type (0%), low-frequency (1-9%), high-frequency (10-100%). Virologic failure by month-24 of efavirenz-based ART, was compared between individuals with and without pretreatment drug-resistance.
The prespecified outcomes of this study included differences in the rate of virologic failure over 24 months of efavirenz-based ART between participants by frequency of drug-resistant variants detected by next-generation sequencing at enrollment. Drug-resistance frequency was defined as the proportion of a nucleotide variant encoding a drug-resistant codon in specimens with at least 100 viral templates sequenced. Virologic failure was defined as plasma HIV RNA of at least 400 copies/ml in sequential specimens or at the final study visit in participants prescribed efavirenz-based ART. \[Milne et al. AIDS 2022 Nov 15;36(14):1949-1958\]
Outcome measures
| Measure |
Pre-ART Oligonucleotide Assay (OLA)
n=322 Participants
Pre-ART OLA will be tested for resistance at 5 pol codons conferring high-level resistance to NNRTI and 3TC (K103N, V106M, Y181C, G190A and M184V)
Pre-ART Oligonucleotide Assay (OLA): Block randomization (1:1) to pre-ART OLA testing or OLA testing after 12mo on ART
|
No OLA (Standard of Care [SOC])
n=30 Participants
The participants will receive standard of care as per Kenya guidelines but will be offered OLA resistance testing after 12 months
|
|---|---|---|
|
Determination of Whether Low-level ARV Resistance (<5%) Detected by PYRO But Not by OLA is Associated With Virologic Failure
Low-frequency resistance
|
10 Participants
|
5 Participants
|
|
Determination of Whether Low-level ARV Resistance (<5%) Detected by PYRO But Not by OLA is Associated With Virologic Failure
High-frequency resistance
|
11 Participants
|
5 Participants
|
|
Determination of Whether Low-level ARV Resistance (<5%) Detected by PYRO But Not by OLA is Associated With Virologic Failure
Wild-type resistance
|
301 Participants
|
20 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 15 monthsPopulation: Technology transfer to Kenya is described, including quality control measures and a discussion of issues. Duarte et a. AIDS 2018, 32:2301-2308
Technology transfer of OLA to the Hope Center Laboratory in Kenya is described, including intra- and inter-assay the reproducibility, and discussion of obstacles and possible solutions. Duarte et a. AIDS 2018, 32:2301-2308
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 15 monthsPopulation: DBS were not tested in Kenya.
DBS were not tested in Kenya and thus, the comparison of OLA results obtained using DBS in Kenya to retesting of same specimens with input of viral templates measured in Seattle was not evaluated.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: EnrollmentPopulation: Among the subgroup of enrollment samples with both OLA and CS testing, we compared mutation detection by each method at OLA codons and assessed mutations at non-OLA codons detected by CS. Only mutations with Stanford HIVDR Program drug resistance mutation scores ≥10 were included.
Rates of pre-treatment drug resistance among all study participants in the study were assessed by OLA but not by consensus sequencing (CS) due to the high cost of sequencing the entire population. However, all mutations detected by OLA were confirmed by CS in Seattle, and if not detected by CS were confirmed by next generation Illumina sequencing. Participants with any indeterminate OLA results were also sequenced to determine the genotype at the indeterminate codon.
Outcome measures
| Measure |
Pre-ART Oligonucleotide Assay (OLA)
n=475 Participants
Pre-ART OLA will be tested for resistance at 5 pol codons conferring high-level resistance to NNRTI and 3TC (K103N, V106M, Y181C, G190A and M184V)
Pre-ART Oligonucleotide Assay (OLA): Block randomization (1:1) to pre-ART OLA testing or OLA testing after 12mo on ART
|
No OLA (Standard of Care [SOC])
n=475 Participants
The participants will receive standard of care as per Kenya guidelines but will be offered OLA resistance testing after 12 months
|
|---|---|---|
|
Detection of Resistance Mutations at OLA Codons by OLA vs. Consensus Sequencing
K103N
|
69 Participants
|
44 Participants
|
|
Detection of Resistance Mutations at OLA Codons by OLA vs. Consensus Sequencing
Y181C
|
19 Participants
|
14 Participants
|
|
Detection of Resistance Mutations at OLA Codons by OLA vs. Consensus Sequencing
G190A
|
16 Participants
|
9 Participants
|
|
Detection of Resistance Mutations at OLA Codons by OLA vs. Consensus Sequencing
K65R
|
9 Participants
|
8 Participants
|
|
Detection of Resistance Mutations at OLA Codons by OLA vs. Consensus Sequencing
M184V
|
16 Participants
|
8 Participants
|
|
Detection of Resistance Mutations at OLA Codons by OLA vs. Consensus Sequencing
Not detected
|
346 Participants
|
392 Participants
|
Adverse Events
Pre-ART Oligonucleotide Assay (OLA)
No OLA (Standard of Care [SOC])
Serious adverse events
| Measure |
Pre-ART Oligonucleotide Assay (OLA)
n=492 participants at risk
Pre-ART OLA will be tested for resistance at 5 pol codons conferring high-level resistance to NNRTI and 3TC (K103N, V106M, Y181C, G190A and M184V)
Pre-ART Oligonucleotide Assay (OLA): Block randomization (1:1) to pre-ART OLA testing or OLA testing after 12mo on ART
|
No OLA (Standard of Care [SOC])
n=495 participants at risk
The participants will receive standard of care as per Kenya guidelines but will be offered OLA resistance testing after 12 months
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.61%
3/492 • 2 years
|
0.81%
4/495 • 2 years
|
|
Infections and infestations
Cryptococcal Meningitis
|
0.20%
1/492 • 2 years
|
0.00%
0/495 • 2 years
|
|
Skin and subcutaneous tissue disorders
Stevens Johnson Syndrome
|
0.00%
0/492 • 2 years
|
0.81%
4/495 • 2 years
|
|
Infections and infestations
Amoebiasis
|
0.20%
1/492 • 2 years
|
0.00%
0/495 • 2 years
|
|
Nervous system disorders
Bell's Palsy
|
0.00%
0/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Reproductive system and breast disorders
Blocked Fallopian Tubes
|
0.61%
3/492 • 2 years
|
0.00%
0/495 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
0.20%
1/492 • 2 years
|
0.00%
0/495 • 2 years
|
|
Pregnancy, puerperium and perinatal conditions
Childbirth
|
0.20%
1/492 • 2 years
|
0.00%
0/495 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.20%
1/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Nervous system disorders
Dizziness
|
0.41%
2/492 • 2 years
|
0.40%
2/495 • 2 years
|
|
Infections and infestations
Esophageal Candidiasis
|
0.00%
0/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Reproductive system and breast disorders
Fibroids
|
0.20%
1/492 • 2 years
|
0.00%
0/495 • 2 years
|
|
Gastrointestinal disorders
Gastric Ulcers
|
0.20%
1/492 • 2 years
|
0.00%
0/495 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal distress
|
0.20%
1/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Nervous system disorders
Headache
|
0.20%
1/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Gastrointestinal disorders
Hemorrhoidectomy
|
0.00%
0/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Reproductive system and breast disorders
Hysterectomy
|
0.20%
1/492 • 2 years
|
0.00%
0/495 • 2 years
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi Sarcoma
|
0.00%
0/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Cardiac disorders
Low Blood Pressure
|
0.00%
0/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Infections and infestations
Menigitis
|
0.20%
1/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Skin and subcutaneous tissue disorders
Nail Discoloration
|
0.20%
1/492 • 2 years
|
0.00%
0/495 • 2 years
|
|
Gastrointestinal disorders
Peptic Ulcer Disease
|
0.61%
3/492 • 2 years
|
0.00%
0/495 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.0%
5/492 • 2 years
|
0.40%
2/495 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.20%
1/492 • 2 years
|
0.40%
2/495 • 2 years
|
|
Gastrointestinal disorders
Rectal Bleeding
|
0.00%
0/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Road Traffic Accident
|
0.61%
3/492 • 2 years
|
0.00%
0/495 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.20%
1/492 • 2 years
|
0.00%
0/495 • 2 years
|
|
Skin and subcutaneous tissue disorders
Swelling
|
0.00%
0/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Infections and infestations
Tuberculosis
|
1.0%
5/492 • 2 years
|
1.0%
5/495 • 2 years
|
|
Reproductive system and breast disorders
Threatened Abortion
|
0.20%
1/492 • 2 years
|
0.00%
0/495 • 2 years
|
|
Endocrine disorders
Thyroidectomy
|
0.00%
0/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
0.41%
2/492 • 2 years
|
0.00%
0/495 • 2 years
|
Other adverse events
| Measure |
Pre-ART Oligonucleotide Assay (OLA)
n=492 participants at risk
Pre-ART OLA will be tested for resistance at 5 pol codons conferring high-level resistance to NNRTI and 3TC (K103N, V106M, Y181C, G190A and M184V)
Pre-ART Oligonucleotide Assay (OLA): Block randomization (1:1) to pre-ART OLA testing or OLA testing after 12mo on ART
|
No OLA (Standard of Care [SOC])
n=495 participants at risk
The participants will receive standard of care as per Kenya guidelines but will be offered OLA resistance testing after 12 months
|
|---|---|---|
|
Gastrointestinal disorders
Bloating
|
0.20%
1/492 • 2 years
|
0.00%
0/495 • 2 years
|
|
Gastrointestinal disorders
Bloody Stool
|
0.00%
0/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Eye disorders
Blurred Vision
|
0.00%
0/492 • 2 years
|
0.40%
2/495 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
0.00%
0/492 • 2 years
|
0.40%
2/495 • 2 years
|
|
Pregnancy, puerperium and perinatal conditions
Childbirth
|
0.20%
1/492 • 2 years
|
0.00%
0/495 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/492 • 2 years
|
0.40%
2/495 • 2 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.20%
1/492 • 2 years
|
0.00%
0/495 • 2 years
|
|
Nervous system disorders
Dizziness
|
0.20%
1/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Gastrointestinal disorders
Gastritis
|
0.20%
1/492 • 2 years
|
0.00%
0/495 • 2 years
|
|
Infections and infestations
Genital Ulcer
|
0.20%
1/492 • 2 years
|
0.00%
0/495 • 2 years
|
|
Endocrine disorders
Goiter
|
0.20%
1/492 • 2 years
|
0.00%
0/495 • 2 years
|
|
Nervous system disorders
Headache
|
0.00%
0/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
0.00%
0/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Skin and subcutaneous tissue disorders
Lip Swelling
|
0.00%
0/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Infections and infestations
Malaria
|
1.0%
5/492 • 2 years
|
0.40%
2/495 • 2 years
|
|
Gastrointestinal disorders
Mouth Ulcer
|
0.20%
1/492 • 2 years
|
0.00%
0/495 • 2 years
|
|
Skin and subcutaneous tissue disorders
Nail Discoloration
|
0.00%
0/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Nervous system disorders
Paresthesia
|
0.20%
1/492 • 2 years
|
0.00%
0/495 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.00%
0/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
7/492 • 2 years
|
0.61%
3/495 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Road Traffic Accident
|
0.20%
1/492 • 2 years
|
0.00%
0/495 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Infections and infestations
Tuberculosis
|
0.61%
3/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Tonsilitis
|
0.00%
0/492 • 2 years
|
0.20%
1/495 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
7/492 • 2 years
|
0.20%
1/495 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place