Trial · NCT03169361
NINLARO Capsules Drug Use-Results Survey (All-Case Surveillance) "Relapsed/Refractory Multiple Myeloma"
NCT03169361, Completed, Takeda; results first posted 2023-12-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. NINLARO Capsules Drug Use-Results Survey (All-Case Surveillance) "Relapsed/Refractory Multiple Myeloma". Trials, record NCT03169361. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03169361
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- NINLARO Capsules Drug Use-Results Survey (All-Case Surveillance) "Relapsed/Refractory Multiple Myeloma"
- NCT number
- NCT03169361
- Status
- Completed
- Enrollment
- 774 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Interventions
- Ixazomib
- First posted
- 2017-05-30
- Last updated
- 2023-12-07
- Results first posted
- 2023-12-07
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Reporting One or More Adverse Events (AEs) | Up to 24 Week (From start of administration to the end of 6 cycles) | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. |
| Primary | Number of Participants Who Had One or More Adverse Drug Reactions (ADRs) | Up to 24 Week (From start of administration to the end of 6 cycles) | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction (ADR) refers to AE related to administered drug. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Reporting One or More Adverse Events (AEs) | Up to 24 Week (From start of administration to the end of 6 cycles) | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Had One or More Adverse Drug Reactions (ADRs) | Up to 24 Week (From start of administration to the end of 6 cycles) | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Reporting One or More Adverse Events (AEs) | Ixazomib 4 mg | 642 | Participants | ||
| Number of Participants Who Had One or More Adverse Drug Reactions (ADRs) | Ixazomib 4 mg | 573 | 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 | Ixazomib 4 mg | 774 | |
| Overall Study | COMPLETED | Ixazomib 4 mg | 742 | |
| Overall Study | NOT COMPLETED | Ixazomib 4 mg | 32 |
Source ClinicalTrials.gov
Adverse events108
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 | Thrombocytopenia | Blood and lymphatic system disorders | Ixazomib 4 mg | 313 | 742 | |
| other | Neuropathy peripheral | Nervous system disorders | Ixazomib 4 mg | 45 | 742 | |
| other | Diarrhoea | Gastrointestinal disorders | Ixazomib 4 mg | 178 | 742 | |
| other | Nausea | Gastrointestinal disorders | Ixazomib 4 mg | 82 | 742 | |
| other | Vomiting | Gastrointestinal disorders | Ixazomib 4 mg | 52 | 742 | |
| other | Rash | Skin and subcutaneous tissue disorders | Ixazomib 4 mg | 52 | 742 | |
| serious | Bacteraemia | Infections and infestations | Ixazomib 4 mg | 1 | 742 | |
| serious | Bronchitis | Infections and infestations | Ixazomib 4 mg | 3 | 742 | |
| serious | Bronchopulmonary aspergillosis | Infections and infestations | Ixazomib 4 mg | 1 | 742 | |
| serious | Escherichia sepsis | Infections and infestations | Ixazomib 4 mg | 1 | 742 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ixazomib 4 mg | 11 | 742 |
| Total, other adverse events | Ixazomib 4 mg | 515 | 742 |
| Total, serious adverse events | Ixazomib 4 mg | 193 | 742 |
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/NCT03169361
GET https://conductscience.org/api/trials/v1/NCT03169361/events?page=2