Comparison · NCT01263015-sae
DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily vs EFV/TDF/FTC 600/200/300 mg Once Daily: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily vs EFV/TDF/FTC 600/200/300 mg Once Daily: serious adverse events. Trial comparisons, record NCT01263015-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01263015-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.157 | 0.125 | 0.195 | wilson | |
| Risk in group 2 | 0.143 | 0.113 | 0.18 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0138 | -0.0349 | 0.0625 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.1 | 0.793 | 1.52 | log | |
| Odds ratio, group 1 over group 2 | 1.11 | 0.762 | 1.63 | log | |
| Number needed to harm, for one more participant with a serious adverse event on DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily than on EFV/TDF/FTC 600/200/300 mg Once Daily | 72.4 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase. | 65 | 414 | EG000 |
| Group 2 | EFV/TDF/FTC 600/200/300 mg Once Daily | During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase. | 60 | 419 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to Week 144 (average of 877.4 study days for DTG; average of 788.8 study days for EFV/TDF/FTC).
Source ClinicalTrials.gov
Trial
- Title
- A Trial Comparing GSK1349572 50mg Plus Abacavir/Lamivudine Once Daily to Atripla (Also Called The SINGLE Trial)
- NCT number
- NCT01263015
- Phases
- PHASE3
- Conditions
- Infection, Human Immunodeficiency Virus I
- Interventions
- Dolutegravir, Atripla, Abacavir/Lamivudine, Abacavir/Lamivudine Placebo, Dolutegravir placebo, Atripla placebo
- Lead sponsor
- ViiV Healthcare
- Results first posted
- 2014-07-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01263015?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
Read this comparison from software.
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GET https://conductscience.org/api/comparisons/v1/NCT01263015-sae