Trial · NCT04307134
Besponsa Post Marketing Surveillance Study
NCT04307134, Completed, Pfizer; results first posted 2025-12-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Besponsa Post Marketing Surveillance Study. Trials, record NCT04307134. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04307134
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Besponsa Post Marketing Surveillance Study
- NCT number
- NCT04307134
- Status
- Completed
- Enrollment
- 108 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Hematologic Malignancy
- Interventions
- Inotuzumab ozogamicin
- First posted
- 2020-03-13
- Last updated
- 2025-12-31
- Results first posted
- 2025-12-31
Source ClinicalTrials.gov
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. AEs included both SAEs and all non-SAEs. An SAE was any untoward medical occurrence in a participant administered a medicinal or nutritional product at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect or was an important medical event. |
| Primary | Number of Participants With Adverse Drug Reactions (ADRs) and Serious ADRs (SADRs) | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An ADR was any untoward medical occurrence attributed to medicinal product in participant who had received that product. SADR was an ADR that resulted in any of the following: death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect; or was an important medical event. |
| Primary | Number of Participants With Unexpected AEs and SAEs | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. An SAE was any untoward medical occurrence in a participant administered a medicinal or nutritional product at any dose that: resulted in death; is life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect or was an important medical event. An AE was considered expected if the reported event and its specificity or severity were consistent with as pre-specified in the protocol, other than these all AEs were unexpected. |
| Primary | Number of Participants With Unexpected ADRs and SADRs | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An ADR was any untoward medical occurrence attributed to medicinal product in participant who had received that product. SADR was an ADR that resulted in any of the following: death; was life-threatening; required inpatient hospitalization/prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect; or was important medical event. In this outcome measure, number of participants with unexpected ADRs and SADRs are reported. An ADR was considered expected if the reported event and its specificity or severity were consistent with as pre-specified in the protocol, other than these all ADRs were unexpected. |
| Primary | Number of AEs According to Severity | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. AEs' severity was graded using common terminology criteria for AEs (CTCAE) version 4.0; grade 1= mild AE; grade 2= moderate AE; grade 3= severe AE; grade 4= life-threatening AE and grade 5= death. |
| Primary | Number of AEs According to Action Taken | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of AEs were classified as per action taken for AEs (withdrawn \[temporarily or permanently or delayed\]; dose reduced; dose increased; dose not changed; unknown, and not applicable) in this outcome measure. Not applicable per protocol referred to situations if participant died or if the treatment was completed prior to the reaction/event or if drug was not administered. |
| Primary | Number of AEs According to SAEs' Category | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of AEs were classified as per SAEs category (resulted in death; is life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect and is an important medical event) in this outcome measure. One SAE could have more than 1 outcome/characteristic and have been counted in more than one category. |
| Primary | Number of AEs According to Their Outcomes | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of AEs were classified as per their outcomes (recovered, recovered with sequelae, recovering, not recovered, and unknown) in this outcome measure. |
| Primary | Number of AEs Based on Causality of AEs to the Study Drug | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | AE: any untoward medical occurrence in participant administered medicinal product. Number of AEs per causality of AE to study drug (certain, probable/likely, possible, unlikely, conditional/unclassified, and not-assessable/unclassifiable) were reported. Certain: couldn't be explained by other drugs, had clinically reasonable reaction on cessation of drug and pharmacological/phenomenological reaction to drug re-administration. Probable/likely: couldn't be explained by other drugs, had clinically reasonable reaction on drug cessation. Possible: could also be explained by other drugs, lacked information/unclear information on drug discontinuation. Unlikely: not likely to have causal relationship from drug administration, could also be explained by other drugs. Conditional/unclassified: needed more data to make appropriate assessment/additional of data being reviewed. Not-assessable: lacked sufficient information/conflicting information hampering accurate causality assessment. |
| Primary | Number of AEs Based on Other Causality of AEs | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of AEs were classified as per other causality of AE to the study drug (disease under the study, other disease, concomitant treatment drug or non-drug, and others) in this outcome measure. |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 registered outcomesOutcomes34
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | The safety analysis set included participants who have been administered Inotuzumab Ozogamicin at least once and evaluated with safety-related outcome measures at least once. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adverse Drug Reactions (ADRs) and Serious ADRs (SADRs) | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | The safety analysis set included participants who have been administered Inotuzumab Ozogamicin at least once and evaluated with safety-related outcome measures at least once. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Unexpected AEs and SAEs | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | The safety analysis set included participants who have been administered Inotuzumab Ozogamicin at least once and evaluated with safety-related outcome measures at least once. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Unexpected ADRs and SADRs | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | The safety analysis set included participants who have been administered Inotuzumab Ozogamicin at least once and evaluated with safety-related outcome measures at least once. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of AEs According to Severity | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | The safety analysis set included participants who have been administered Inotuzumab Ozogamicin at least once and evaluated with safety-related outcome measures at least once. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure who had any AE and Overall Number of Units Analyzed signifies evaluable number of AEs. | Adverse Events | NUMBER |
| PRIMARY | Number of AEs According to Action Taken | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | The safety analysis set included participants who have been administered Inotuzumab Ozogamicin at least once and evaluated with safety-related outcome measures at least once. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure who had any AE and Overall Number of Units Analyzed signifies evaluable number of AEs. | Adverse Events | NUMBER |
| PRIMARY | Number of AEs According to SAEs' Category | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | The safety analysis set included participants who have been administered Inotuzumab Ozogamicin at least once and evaluated with safety-related outcome measures at least once. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure who had any SAE and Overall Number of Units Analyzed signifies evaluable number of SAEs. | Serious Adverse Events | NUMBER |
| PRIMARY | Number of AEs According to Their Outcomes | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | The safety analysis set included participants who have been administered Inotuzumab Ozogamicin at least once and evaluated with safety-related outcome measures at least once. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure who had any AE and Overall Number of Units Analyzed signifies evaluable number of AEs. | Adverse Events | NUMBER |
| PRIMARY | Number of AEs Based on Causality of AEs to the Study Drug | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | The safety analysis set included participants who have been administered Inotuzumab Ozogamicin at least once and evaluated with safety-related outcome measures at least once. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure who had any AE and Overall Number of Units Analyzed signifies evaluable number of AEs. | Adverse Events | NUMBER |
| PRIMARY | Number of AEs Based on Other Causality of AEs | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | The safety analysis set included participants who have been administered Inotuzumab Ozogamicin at least once and evaluated with safety-related outcome measures at least once. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure who had any AE and Overall Number of Units Analyzed signifies number of AEs evaluable for this outcome measure. | Adverse Events | NUMBER |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 outcomesResults by group97
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Inotuzumab Ozogamicin | Participants with AEs | 99 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Inotuzumab Ozogamicin | Participants with SAEs | 34 | Participants | |
| Number of Participants With Adverse Drug Reactions (ADRs) and Serious ADRs (SADRs) | Inotuzumab Ozogamicin | Participants with ADRs | 53 | Participants | |
| Number of Participants With Adverse Drug Reactions (ADRs) and Serious ADRs (SADRs) | Inotuzumab Ozogamicin | Participants with SADRs | 4 | Participants | |
| Number of Participants With Unexpected AEs and SAEs | Inotuzumab Ozogamicin | Participants with unexpected AEs | 85 | Participants | |
| Number of Participants With Unexpected AEs and SAEs | Inotuzumab Ozogamicin | Participants with unexpected SAEs | 24 | Participants | |
| Number of Participants With Unexpected ADRs and SADRs | Inotuzumab Ozogamicin | Participants with unexpected ADRs | 15 | Participants | |
| Number of Participants With Unexpected ADRs and SADRs | Inotuzumab Ozogamicin | Participants with unexpected SADRs | 1 | Participants | |
| Number of AEs According to Severity | Inotuzumab Ozogamicin | Grade 1 AEs | 252 | Adverse Events | |
| Number of AEs According to Severity | Inotuzumab Ozogamicin | Grade 2 AEs | 339 | Adverse Events |
1 to 10 of 97Source ClinicalTrials.gov
See all 97 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Inotuzumab Ozogamicin | 108 | |
| Overall Study | Enrolled | Inotuzumab Ozogamicin | 108 | |
| Overall Study | Treated | Inotuzumab Ozogamicin | 107 | |
| Overall Study | COMPLETED | Inotuzumab Ozogamicin | 78 | |
| Overall Study | NOT COMPLETED | Inotuzumab Ozogamicin | 30 |
Source ClinicalTrials.gov
Adverse events249
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 | Neutropenia | Blood and lymphatic system disorders | Inotuzumab Ozogamicin | 29 | 107 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Inotuzumab Ozogamicin | 28 | 107 | |
| other | Anaemia | Blood and lymphatic system disorders | Inotuzumab Ozogamicin | 19 | 107 | |
| other | Cytopenia | Blood and lymphatic system disorders | Inotuzumab Ozogamicin | 11 | 107 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Inotuzumab Ozogamicin | 10 | 107 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Inotuzumab Ozogamicin | 2 | 107 | |
| other | Thrombotic microangiopathy | Blood and lymphatic system disorders | Inotuzumab Ozogamicin | 2 | 107 | |
| other | Bicytopenia | Blood and lymphatic system disorders | Inotuzumab Ozogamicin | 1 | 107 | |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Inotuzumab Ozogamicin | 1 | 107 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Inotuzumab Ozogamicin | 1 | 107 |
1 to 10 of 249Source ClinicalTrials.gov
See all 249 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Inotuzumab Ozogamicin | 24 | 107 |
| Total, other adverse events | Inotuzumab Ozogamicin | 97 | 107 |
| Total, serious adverse events | Inotuzumab Ozogamicin | 34 | 107 |
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/NCT04307134
GET https://conductscience.org/api/trials/v1/NCT04307134/registered?page=2