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Comparison · NCT02760862-sae

Group (I) (N=25) vs Group (II) (N=25): 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. Group (I) (N=25) vs Group (II) (N=25): serious adverse events. Trial comparisons, record NCT02760862-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02760862-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 100.00000000000000001390.133wilson
Risk in group 200.00000000000000001390.133wilson
Risk difference, group 1 minus group 20-0.1330.133newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Group (I) (N=25)
Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours (Hydrocortisone as sodium succinate, vial, equivalent to hydrocortisone 100mg, Egyptian INT, Pharmaceutical Industries CO. ARE,EIPICO.EGYPT).~hydrocortisone 100mg.: Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours
025EG000
Group 2Group (II) (N=25)
group (II), received mannitol 20% intravenous fluid (100ml intravenously which was given over 30 minutes and followed by 100 ml on a 12hour basis for 48 hours) (Manufactured by Allmed Middle East, Egypt).~mannitol 20% intravenous fluid: group (II), received mannitol 20% 100ml intravenously which was given over 30 minutes and followed by 100 ml on a 12hour basis. Urinary catheter was inserted for patients in group (II) under complete aseptic conditions by the anesthesia resident before the start of mannitol infusion and removed after its discontinuation, accompanied by the intravenous fluid infusion over 48 hours of 500ml of normal saline or Ringer's solution every 8 hours and the input/output fluid chart for evaluation of fluid balance.
025EG001

Harm

What it counts
Total, serious adverse events
Time frame

Source ClinicalTrials.gov

Trial

Title
Comparative Study Between Hydrocortisone and Mannitol in Treatment of Postdural Puncture Headache
NCT number
NCT02760862
Phases
PHASE4
Conditions
Headache
Interventions
hydrocortisone 100mg., mannitol 20% intravenous fluid
Lead sponsor
Ain Shams University
Results first posted
2020-08-25

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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