Trial · NCT03381573
Long-term Observational Study of the Safety of Roflumilast
NCT03381573, Completed, AstraZeneca
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-term Observational Study of the Safety of Roflumilast. Trials, record NCT03381573. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03381573
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Observational Study of the Safety of Roflumilast
- NCT number
- NCT03381573
- Status
- Completed
- Enrollment
- 135,856 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- COPD
- Interventions
- Roflumilast
- First posted
- 2017-12-22
- Last updated
- 2023-09-26
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | All-cause mortality | up to 5 years | Safety objective to estimate 5-year all-cause mortality |
| Secondary | death by suicide or hospitalization for suicide attempt | up to 5 years | Secondary safety issue (occurring up to 5 years) |
| Secondary | hospitalization for any cause | up to 5 years | secondary safety issue (occurring up to 5 years) |
| Secondary | Major cardiovascular events | up to 5 years | secondary safety issue (occurring up to 5 years) |
| Secondary | Respiratory disease related hospitalization | up to 5 years | secondary safety issue (occurring up to 5 years) |
| Secondary | New diagnoses of depression | up to 5 years | secondary safety issue (occurring up to 5 years) |
| Secondary | New diagnoses of malignant neoplasm | up to 5 years | secondary safety issue (occurring up to 5 years) |
| Secondary | Hospitalization due to serious diarrhea of non-infectious origin | up to 5 years | secondary safety issue (occurring up to 5 years) |
| Secondary | Abnormal and unexplained weight loss | up to 5 years | secondary safety issue (occurring up to 5 years) |
| Secondary | New diagnosis of tuberculosis or hepatitis B or C | up to 5 years | secondary safety issue (occurring up to 5 years) |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03381573
GET https://conductscience.org/api/trials/v1/NCT03381573/registered