Trial Outcomes & Findings for Human IL-15 (rhIL-15) and Obinutuzumab for Relapsed and Refractory Chronic Lymphocyte Leukemia (NCT NCT03759184)
NCT ID: NCT03759184
Last Updated: 2022-03-22
Results Overview
Here is the number of treatment-emergent AEs related to rhIL-15 assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. A treatment emergent AE is defined as
TERMINATED
PHASE1
1 participants
28 days or 4 weeks (cycle 1)
2022-03-22
Participant Flow
No participants were enrolled on the dose expansion phase of the study because the study was closed after \> 1 year of inactivity.
Participant milestones
| Measure |
Arm 1 - Dose Escalation - Dose Level 1
Each cycle of treatment is 28 days or 4 weeks, and a maximum of 6 cycles will be administered.
Participant was treated with continuous intravenous (civ) interleukin-15 (IL-15) on dose level 1 with 0.5 mcg/kg/day on days 1-5 of cycles 1-6.
Obinutuzumab (IV) will be administered at a dose of 100 mg on day 4, 900 mg on day 5, 1,000 mg on day 11, and 1,000 mg on day 18 of cycle 1: then 1,000 mg on day 4 of each subsequent cycle.
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Human IL-15 (rhIL-15) and Obinutuzumab for Relapsed and Refractory Chronic Lymphocyte Leukemia
Baseline characteristics by cohort
| Measure |
Arm 1 - Dose Escalation - Dose Level 1
n=1 Participants
Each cycle of treatment is 28 days or 4 weeks, and a maximum of 6 cycles will be administered.
Participant was treated with continuous intravenous (civ) interleukin-15 (IL-15) on dose level 1 with 0.5 mcg/kg/day on days 1-5 of cycles 1-6.
Obinutuzumab (IV) will be administered at a dose of 100 mg on day 4, 900 mg on day 5, 1,000 mg on day 11, and 1,000 mg on day 18 of cycle 1: then 1,000 mg on day 4 of each subsequent cycle.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
54.4 years
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days or 4 weeks (cycle 1)Here is the number of treatment-emergent AEs related to rhIL-15 assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. A treatment emergent AE is defined as
Outcome measures
| Measure |
Arm 1 - Dose Escalation - Dose Level 1
n=1 Participants
Each cycle of treatment is 28 days or 4 weeks, and a maximum of 6 cycles will be administered.
Participant was treated with continuous intravenous (civ) interleukin-15 (IL-15) on dose level 1 with 0.5 mcg/kg/day on days 1-5 of cycles 1-6.
Obinutuzumab (IV) will be administered at a dose of 100 mg on day 4, 900 mg on day 5, 1,000 mg on day 11, and 1,000 mg on day 18 of cycle 1: then 1,000 mg on day 4 of each subsequent cycle.
|
|---|---|
|
Number of Treatment-emergent Adverse Events (AEs) Related to Recombinant Human Interleukin-15 (rhIL-15)
|
0 adverse events
|
PRIMARY outcome
Timeframe: 28 days or 4 weeks (cycle 1)Here is the number of treatment-emergent AEs related to Obinutuzumab assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. A treatment emergent AE is defined as
Outcome measures
| Measure |
Arm 1 - Dose Escalation - Dose Level 1
n=1 Participants
Each cycle of treatment is 28 days or 4 weeks, and a maximum of 6 cycles will be administered.
Participant was treated with continuous intravenous (civ) interleukin-15 (IL-15) on dose level 1 with 0.5 mcg/kg/day on days 1-5 of cycles 1-6.
Obinutuzumab (IV) will be administered at a dose of 100 mg on day 4, 900 mg on day 5, 1,000 mg on day 11, and 1,000 mg on day 18 of cycle 1: then 1,000 mg on day 4 of each subsequent cycle.
|
|---|---|
|
Number of Treatment-emergent Adverse Events (AEs) Related to Obinutuzumab
|
0 adverse events
|
PRIMARY outcome
Timeframe: 28 days or 4 weeks (cycle 1)A DLT is defined as a grade 3-5 toxicity if not incontrovertibly due to disease progression or an extraneous cause, and deemed possibly, probably, or definitely related to interleukin-15 by the principal investigator during the first 28 days of treatment. Some exceptions are grade 3 or 4 lymphocytopenia or neutropenia without clinical signs of infection grade 2 or above, grade 3 or 4 thrombocytopenia lasting fewer than 5 days and not associated with bleeding or purpura. Transient (\<24 hours) grade 3 hypoalbuminemia, hypokalemia, hypomagnesemia, hyponatremia or hypophosphatemia which responds to medical intervention. Grade 3 is severe, grade 4 is life-threatening, and grade 5 is death related to adverse event.
Outcome measures
| Measure |
Arm 1 - Dose Escalation - Dose Level 1
n=1 Participants
Each cycle of treatment is 28 days or 4 weeks, and a maximum of 6 cycles will be administered.
Participant was treated with continuous intravenous (civ) interleukin-15 (IL-15) on dose level 1 with 0.5 mcg/kg/day on days 1-5 of cycles 1-6.
Obinutuzumab (IV) will be administered at a dose of 100 mg on day 4, 900 mg on day 5, 1,000 mg on day 11, and 1,000 mg on day 18 of cycle 1: then 1,000 mg on day 4 of each subsequent cycle.
|
|---|---|
|
Number of Participants With a Grades 3-5 Dose-limiting Toxicity (DLT) of Continuous Intravenous (CIV) Recombinant Human Interleukin-15 (rhIL-15) Treatment
Grade 3 Possibly Related
|
0 Participants
|
|
Number of Participants With a Grades 3-5 Dose-limiting Toxicity (DLT) of Continuous Intravenous (CIV) Recombinant Human Interleukin-15 (rhIL-15) Treatment
Grade 3 Probably Related
|
0 Participants
|
|
Number of Participants With a Grades 3-5 Dose-limiting Toxicity (DLT) of Continuous Intravenous (CIV) Recombinant Human Interleukin-15 (rhIL-15) Treatment
Grade 3 Definitely Related
|
0 Participants
|
|
Number of Participants With a Grades 3-5 Dose-limiting Toxicity (DLT) of Continuous Intravenous (CIV) Recombinant Human Interleukin-15 (rhIL-15) Treatment
Grade 4 Possibly Related
|
0 Participants
|
|
Number of Participants With a Grades 3-5 Dose-limiting Toxicity (DLT) of Continuous Intravenous (CIV) Recombinant Human Interleukin-15 (rhIL-15) Treatment
Grade 4 Probably Related
|
0 Participants
|
|
Number of Participants With a Grades 3-5 Dose-limiting Toxicity (DLT) of Continuous Intravenous (CIV) Recombinant Human Interleukin-15 (rhIL-15) Treatment
Grade 4 Definitely Related
|
0 Participants
|
|
Number of Participants With a Grades 3-5 Dose-limiting Toxicity (DLT) of Continuous Intravenous (CIV) Recombinant Human Interleukin-15 (rhIL-15) Treatment
Grade 5 Possibly Related
|
0 Participants
|
|
Number of Participants With a Grades 3-5 Dose-limiting Toxicity (DLT) of Continuous Intravenous (CIV) Recombinant Human Interleukin-15 (rhIL-15) Treatment
Grade 5 Probably Related
|
0 Participants
|
|
Number of Participants With a Grades 3-5 Dose-limiting Toxicity (DLT) of Continuous Intravenous (CIV) Recombinant Human Interleukin-15 (rhIL-15) Treatment
Grade 5 Definitely Related
|
0 Participants
|
PRIMARY outcome
Timeframe: 28 days or 4 weeks (cycle 1)A DLT is defined as a grade 3-5 toxicity if not incontrovertibly due to disease progression or an extraneous cause, and deemed possibly, probably, or definitely related to Obinutuzumab by the principal investigator during the first 28 days of treatment. Some exceptions are grade 3 or 4 lymphocytopenia or neutropenia without clinical signs of infection grade 2 or above, grade 3 or 4 thrombocytopenia lasting fewer than 5 days and not associated with bleeding or purpura. Transient (\<24 hours) grade 3 hypoalbuminemia, hypokalemia, hypomagnesemia, hyponatremia or hypophosphatemia which responds to medical intervention. Grade 3 is severe, grade 4 is life-threatening, and grade 5 is death related to adverse event.
Outcome measures
| Measure |
Arm 1 - Dose Escalation - Dose Level 1
n=1 Participants
Each cycle of treatment is 28 days or 4 weeks, and a maximum of 6 cycles will be administered.
Participant was treated with continuous intravenous (civ) interleukin-15 (IL-15) on dose level 1 with 0.5 mcg/kg/day on days 1-5 of cycles 1-6.
Obinutuzumab (IV) will be administered at a dose of 100 mg on day 4, 900 mg on day 5, 1,000 mg on day 11, and 1,000 mg on day 18 of cycle 1: then 1,000 mg on day 4 of each subsequent cycle.
|
|---|---|
|
Number of Participants With a Grade 3-5 Dose-limiting Toxicity (DLT) With Intravenous (IV) Obinutuzumab Treatment
Grade 3 Possibly Related
|
0 Participants
|
|
Number of Participants With a Grade 3-5 Dose-limiting Toxicity (DLT) With Intravenous (IV) Obinutuzumab Treatment
Grade 3 Probably Related
|
0 Participants
|
|
Number of Participants With a Grade 3-5 Dose-limiting Toxicity (DLT) With Intravenous (IV) Obinutuzumab Treatment
Grade 3 Definitely Related
|
0 Participants
|
|
Number of Participants With a Grade 3-5 Dose-limiting Toxicity (DLT) With Intravenous (IV) Obinutuzumab Treatment
Grade 4 Possibly Related
|
0 Participants
|
|
Number of Participants With a Grade 3-5 Dose-limiting Toxicity (DLT) With Intravenous (IV) Obinutuzumab Treatment
Grade 4 Probably Related
|
0 Participants
|
|
Number of Participants With a Grade 3-5 Dose-limiting Toxicity (DLT) With Intravenous (IV) Obinutuzumab Treatment
Grade 4 Definitely Related
|
0 Participants
|
|
Number of Participants With a Grade 3-5 Dose-limiting Toxicity (DLT) With Intravenous (IV) Obinutuzumab Treatment
Grade 5 Possibly Related
|
0 Participants
|
|
Number of Participants With a Grade 3-5 Dose-limiting Toxicity (DLT) With Intravenous (IV) Obinutuzumab Treatment
Grade 5 Probably Related
|
0 Participants
|
|
Number of Participants With a Grade 3-5 Dose-limiting Toxicity (DLT) With Intravenous (IV) Obinutuzumab Treatment
Grade 5 Definitely Related
|
0 Participants
|
PRIMARY outcome
Timeframe: 28 days or 4 weeks (cycle 1)Population: This outcome measure was not done. The MTD was not found because the study was closed after \> 1 year of inactivity and only one participant was enrolled.
The MTD is the dose level at which no more than 1 of up to 6 participants experience a dose limiting toxicity (DLT) during the DLT evaluation window, or the dose at which at least 2 of ≤ 6 participants have DLT. A DLT is defined as a grade 3-5 toxicity if not incontrovertibly due to disease progression or an extraneous cause, and deemed possibly, probably, or definitely related to interleukin-15 by the principal investigator during the first 28 days of treatment.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 28 days or 4 weeks (cycle 1)Population: This outcome measure was not done. The MTD was not found because the study was closed after \> 1 year of inactivity and only one participant was enrolled.
The MTD is the dose level at which no more than 1 of up to 6 participants experience a dose limiting toxicity (DLT) during the DLT evaluation window, or the dose at which at least 2 of ≤ 6 participants have DLT. A DLT is defined as a grade 3-5 toxicity if not incontrovertibly due to disease progression or an extraneous cause, and deemed possibly, probably, or definitely related to Obinutuzumab by the principal investigator during the first 28 days of treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: time measurement criteria are met for CR, CRi, or PR whichever is recorded first until the first date that recurrent of progressive disease is objectively documented or death, approximately 27 monthsDOR is measured from the time measurement criteria are met for complete response (CR), complete response with incomplete marrow recovery (CRi), or partial response (PR) whichever is recorded first until the first date that recurrent of progressive disease is objectively documented, death, or in the absence of progressive disease (PD), date of last assessment. Response was assessed by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines. Complete response (CR) is disease related constitutional symptoms resolved; partial response (PR) is two criteria from Group A (e.g. lymphadenopathy or liver and/or spleen size) if abnormal at baseline plus one of the criteria from Group B (e.g. platelet count) must be met; complete response with incomplete marrow recovery (CRi) is CR with incomplete hematopoietic recovery; stable disease (SD) is defined as not achieving CR or PR, and PD is development of transformation to a more aggressive histology.
Outcome measures
| Measure |
Arm 1 - Dose Escalation - Dose Level 1
n=1 Participants
Each cycle of treatment is 28 days or 4 weeks, and a maximum of 6 cycles will be administered.
Participant was treated with continuous intravenous (civ) interleukin-15 (IL-15) on dose level 1 with 0.5 mcg/kg/day on days 1-5 of cycles 1-6.
Obinutuzumab (IV) will be administered at a dose of 100 mg on day 4, 900 mg on day 5, 1,000 mg on day 11, and 1,000 mg on day 18 of cycle 1: then 1,000 mg on day 4 of each subsequent cycle.
|
|---|---|
|
Duration of Response (DOR)
|
0 Months
There is no confidence interval with 1 sample result.
|
SECONDARY outcome
Timeframe: 6 cycles (each cycle is 28 days or 4 weeks)Overall response is defined as the best response recorded from the start of the treatment until disease progression/recurrence. OS was estimated using the Kaplan-Meier curves and a 95% confidence interval. Response was assessed by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines. Complete response (CR) is disease related constitutional symptoms resolved; Partial response (PR) is two criteria from Group A (e.g. lymphadenopathy or liver and/or spleen size) if abnormal at baseline plus one of the criteria from Group B (e.g. platelet count) must be met, requires the absence of growth factor or transfusion support; Complete response with incomplete marrow recovery (CRi) is CR with incomplete hematopoietic recovery; Stable disease (SD) is defined as not achieving CR or PR, but not fulfilling the criteria for progressive disease (PD); and PD is one criteria from Group A or B are met or development of transformation to a more aggressive histology.
Outcome measures
| Measure |
Arm 1 - Dose Escalation - Dose Level 1
n=1 Participants
Each cycle of treatment is 28 days or 4 weeks, and a maximum of 6 cycles will be administered.
Participant was treated with continuous intravenous (civ) interleukin-15 (IL-15) on dose level 1 with 0.5 mcg/kg/day on days 1-5 of cycles 1-6.
Obinutuzumab (IV) will be administered at a dose of 100 mg on day 4, 900 mg on day 5, 1,000 mg on day 11, and 1,000 mg on day 18 of cycle 1: then 1,000 mg on day 4 of each subsequent cycle.
|
|---|---|
|
Overall Response Rate
Complete Response
|
0 Participants
|
|
Overall Response Rate
Complete Response with incomplete marrow recovery
|
0 Participants
|
|
Overall Response Rate
Partial Response
|
0 Participants
|
|
Overall Response Rate
Stable Disease
|
1 Participants
|
|
Overall Response Rate
Progressive Disease
|
0 Participants
|
SECONDARY outcome
Timeframe: Approximately 8 monthsPopulation: There is no confidence interval with 1 sample result.
EFS is defined as the duration of time from the date of study enrollment until time of disease lapse, disease progression, alternative therapy for lymphoma given, or death, whichever comes first. EFS was estimated using the Kaplan-Meier curves and a 95% confidence interval. Progression was assessed by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines and is defined as one criterion from Group A (e.g., lymphadenopathy or liver and/or spleen size) or B (e.g., platelet count) are met or development of transformation to a more aggressive histology.
Outcome measures
| Measure |
Arm 1 - Dose Escalation - Dose Level 1
n=1 Participants
Each cycle of treatment is 28 days or 4 weeks, and a maximum of 6 cycles will be administered.
Participant was treated with continuous intravenous (civ) interleukin-15 (IL-15) on dose level 1 with 0.5 mcg/kg/day on days 1-5 of cycles 1-6.
Obinutuzumab (IV) will be administered at a dose of 100 mg on day 4, 900 mg on day 5, 1,000 mg on day 11, and 1,000 mg on day 18 of cycle 1: then 1,000 mg on day 4 of each subsequent cycle.
|
|---|---|
|
Event-free Survival (EFS)
|
8 Months
|
SECONDARY outcome
Timeframe: Approximately 27 monthsPopulation: There is no full range with 1 sample result.
OS is defined as the date of on-study to the date of death from any cause or last follow up.
Outcome measures
| Measure |
Arm 1 - Dose Escalation - Dose Level 1
n=1 Participants
Each cycle of treatment is 28 days or 4 weeks, and a maximum of 6 cycles will be administered.
Participant was treated with continuous intravenous (civ) interleukin-15 (IL-15) on dose level 1 with 0.5 mcg/kg/day on days 1-5 of cycles 1-6.
Obinutuzumab (IV) will be administered at a dose of 100 mg on day 4, 900 mg on day 5, 1,000 mg on day 11, and 1,000 mg on day 18 of cycle 1: then 1,000 mg on day 4 of each subsequent cycle.
|
|---|---|
|
Overall Survival (OS)
|
27 Months
|
SECONDARY outcome
Timeframe: Approximately 8 monthsPopulation: There is no full range with 1 sample result.
PFS is defined as the duration of time measurement criteria are met for complete response (CR), complete response with incomplete marrow recovery (CRi), and partial response (PR), whichever is recorded first. PFS was estimated using the Kaplan-Meier curves and a 95% confidence interval. Response was assessed by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines. CR is disease related constitutional symptoms resolved; PR is two criteria from Group A (e.g. lymphadenopathy or liver and/or spleen size) if abnormal at baseline plus one of the criteria from Group B (e.g. platelet count) must be met, requires the absence of growth factor or transfusion support; CRi is CR with incomplete hematopoietic recovery; and progressive disease is one criteria from Group A or B are met or development of transformation to a more aggressive histology.
Outcome measures
| Measure |
Arm 1 - Dose Escalation - Dose Level 1
n=1 Participants
Each cycle of treatment is 28 days or 4 weeks, and a maximum of 6 cycles will be administered.
Participant was treated with continuous intravenous (civ) interleukin-15 (IL-15) on dose level 1 with 0.5 mcg/kg/day on days 1-5 of cycles 1-6.
Obinutuzumab (IV) will be administered at a dose of 100 mg on day 4, 900 mg on day 5, 1,000 mg on day 11, and 1,000 mg on day 18 of cycle 1: then 1,000 mg on day 4 of each subsequent cycle.
|
|---|---|
|
Progression-free Survival (PFS)
|
8 Months
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Date treatment consent signed to date off study, approximately 27 months and 11 days.Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Arm 1 - Dose Escalation - Dose Level 1
n=1 Participants
Each cycle of treatment is 28 days or 4 weeks, and a maximum of 6 cycles will be administered.
Participant was treated with continuous intravenous (civ) interleukin-15 (IL-15) on dose level 1 with 0.5 mcg/kg/day on days 1-5 of cycles 1-6.
Obinutuzumab (IV) will be administered at a dose of 100 mg on day 4, 900 mg on day 5, 1,000 mg on day 11, and 1,000 mg on day 18 of cycle 1: then 1,000 mg on day 4 of each subsequent cycle.
|
|---|---|
|
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).
|
1 Participants
|
Adverse Events
Arm 1 - Dose Escalation - Dose Level 1
Serious adverse events
| Measure |
Arm 1 - Dose Escalation - Dose Level 1
n=1 participants at risk
Each cycle of treatment is 28 days or 4 weeks, and a maximum of 6 cycles will be administered.
Participant was treated with continuous intravenous (civ) interleukin-15 (IL-15) on dose level 1 with 0.5 mcg/kg/day on days 1-5 of cycles 1-6.
Obinutuzumab (IV) will be administered at a dose of 100 mg on day 4, 900 mg on day 5, 1,000 mg on day 11, and 1,000 mg on day 18 of cycle 1: then 1,000 mg on day 4 of each subsequent cycle.
|
|---|---|
|
Ear and labyrinth disorders
Ear pain
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 27 months and 11 days.
|
|
Infections and infestations
Bone infection
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 27 months and 11 days.
|
|
Investigations
Neutrophil count decreased
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 27 months and 11 days.
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 27 months and 11 days.
|
Other adverse events
| Measure |
Arm 1 - Dose Escalation - Dose Level 1
n=1 participants at risk
Each cycle of treatment is 28 days or 4 weeks, and a maximum of 6 cycles will be administered.
Participant was treated with continuous intravenous (civ) interleukin-15 (IL-15) on dose level 1 with 0.5 mcg/kg/day on days 1-5 of cycles 1-6.
Obinutuzumab (IV) will be administered at a dose of 100 mg on day 4, 900 mg on day 5, 1,000 mg on day 11, and 1,000 mg on day 18 of cycle 1: then 1,000 mg on day 4 of each subsequent cycle.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 27 months and 11 days.
|
|
Ear and labyrinth disorders
Ear pain
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 27 months and 11 days.
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 27 months and 11 days.
|
|
General disorders
Fever
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 27 months and 11 days.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 27 months and 11 days.
|
|
Psychiatric disorders
Irritability
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 27 months and 11 days.
|
|
Investigations
Neutrophil count decreased
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 27 months and 11 days.
|
|
Infections and infestations
Paronychia
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 27 months and 11 days.
|
|
Infections and infestations
Sinusitis
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 27 months and 11 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place