Comparison · NCT01755598-sae
M72AS01 Group vs Control Group: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. M72AS01 Group vs Control Group: serious adverse events. Trial comparisons, record NCT01755598-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01755598-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 | 0.0286 | 0.0218 | 0.0373 | wilson | |
| Risk in group 2 | 0.0347 | 0.0272 | 0.0442 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00614 | -0.0178 | 0.00544 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.823 | 0.572 | 1.19 | log | |
| Odds ratio, group 1 over group 2 | 0.818 | 0.561 | 1.19 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on M72AS01 Group than on Control Group | 163 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | M72AS01 Group | Subjects, between, and including, 18 and 50 years of age, who received 2 doses of M72/AS01E according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm. | 51 | 1,786 | EG000 |
| Group 2 | Control Group | Subjects, between, and including,18 and 50 years of age, who received 2 doses of Placebo according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm. | 62 | 1,787 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Solicited local and general symptoms were reported during the 7-day (Days 0-6) post-vaccination period and unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period. SAE(s): were reported during the entire study period (from Month 0 to Month 36 (Year 3).
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate the Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine in Adults
- NCT number
- NCT01755598
- Phases
- PHASE2
- Conditions
- Tuberculosis, Tuberculosis Vaccines
- Interventions
- GSK Biologicals' investigational TB vaccine (GSK692342), Placebo
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2019-12-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01755598?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.
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