Comparison · NCT01336205-03cff126
NKTR-118 25 mg vs Usual Care: Incidence of Patients Experiencing Severe Adverse Events (SAEs)
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. NKTR-118 25 mg vs Usual Care: Incidence of Patients Experiencing Severe Adverse Events (SAEs). Trial comparisons, record NCT01336205-03cff126. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01336205-03cff126
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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 | 0.0955 | 0.0734 | 0.123 | wilson | |
| Risk in group 2 | 0.111 | 0.0789 | 0.154 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0156 | -0.064 | 0.027 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.86 | 0.561 | 1.32 | log | |
| Odds ratio, group 1 over group 2 | 0.845 | 0.524 | 1.36 | log | |
| Number needed to treat, for one fewer participant with the outcome on NKTR-118 25 mg than on Usual Care | 64.1 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: usual care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | NKTR-118 25 mg | NKTR-118 25 mg QD, oral treatment | 51 | 534 | OG000 |
| Group 2 | Usual Care | Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment. | 30 | 270 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Incidence of Patients Experiencing Severe Adverse Events (SAEs)
- Description
- The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.
- Time frame
- Baseline (Week 0) to end of the follow-up period
- Population
The Safety analysis set included all randomized patients who received at least 1 dose of IP and patients who received Usual Care, with the exception of patients who were randomized multiple times within the program at different centers or patients who were randomized at sites where data integrity issues were identified.
Source ClinicalTrials.gov
Trial
- Title
- Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
- NCT number
- NCT01336205
- Phases
- PHASE3
- Conditions
- Opioid-Induced Constipation (OIC)
- Interventions
- NKTR-118, Usual care
- Lead sponsor
- AstraZeneca
- Results first posted
- 2014-10-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01336205?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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