Trial · NCT02075008
Long-term Safety Study of QGE031 in Patients With Allergic Asthma Who Completed Study CQGE031B2201
NCT02075008, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2017-04-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-term Safety Study of QGE031 in Patients With Allergic Asthma Who Completed Study CQGE031B2201. Trials, record NCT02075008. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02075008
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Safety Study of QGE031 in Patients With Allergic Asthma Who Completed Study CQGE031B2201
- NCT number
- NCT02075008
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 270 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Asthma
- Interventions
- QGE031
- First posted
- 2014-03-03
- Last updated
- 2017-08-11
- Other registries' IDs
- eudract:2013-003683-31
- Results first posted
- 2017-04-25
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability | 52 weeks | Safety was monitored throughout the study. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability | 52 weeks | The safety set, which included all participants, was analyzed. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability | QGE031 Every 4 Weeks (q4w) | Non-serious AEs | 176 | Participants | |
| Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability | QGE031 Every 4 Weeks (q4w) | Serious AEs | 19 | Participants | |
| Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability | QGE031 Every 4 Weeks (q4w) | Deaths | 1 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | QGE031 Every 4 Weeks (q4w) | 270 | |
| Overall Study | COMPLETED | QGE031 Every 4 Weeks (q4w) | 94 | |
| Overall Study | NOT COMPLETED | QGE031 Every 4 Weeks (q4w) | 176 |
Source ClinicalTrials.gov
Adverse events22
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site reaction | General disorders | QGE031 Every 4 Weeks (q4w) | 45 | 270 | |
| other | Bronchitis | Infections and infestations | QGE031 Every 4 Weeks (q4w) | 20 | 270 | |
| other | Nasopharyngitis | Infections and infestations | QGE031 Every 4 Weeks (q4w) | 33 | 270 | |
| other | Upper respiratory tract infection | Infections and infestations | QGE031 Every 4 Weeks (q4w) | 17 | 270 | |
| other | Asthma | Respiratory, thoracic and mediastinal disorders | QGE031 Every 4 Weeks (q4w) | 80 | 270 | |
| serious | Myocardial infarction | Cardiac disorders | QGE031 Every 4 Weeks (q4w) | 1 | 270 | |
| serious | Vertigo | Ear and labyrinth disorders | QGE031 Every 4 Weeks (q4w) | 1 | 270 | |
| serious | Goitre | Endocrine disorders | QGE031 Every 4 Weeks (q4w) | 1 | 270 | |
| serious | Cholecystitis acute | Hepatobiliary disorders | QGE031 Every 4 Weeks (q4w) | 1 | 270 | |
| serious | Anaphylactic reaction | Immune system disorders | QGE031 Every 4 Weeks (q4w) | 1 | 270 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | QGE031 Every 4 Weeks (q4w) | ||
| Total, other adverse events | QGE031 Every 4 Weeks (q4w) | 130 | 270 |
| Total, serious adverse events | QGE031 Every 4 Weeks (q4w) | 19 | 270 |
Source ClinicalTrials.gov
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/NCT02075008
GET https://conductscience.org/api/trials/v1/NCT02075008/events?page=2