Trial Outcomes & Findings for Safety and Efficacy Evaluation of Bosutinib Plus Atezolizumab in Newly Diagnosed Chronic Leukemia Adult Patients (NCT NCT04793399)
NCT ID: NCT04793399
Last Updated: 2024-03-19
Results Overview
All Adverse Events, despite their severity or causal relationship with the study medication, will be reported, graded according CTCAE v5.0 and analyzed.
TERMINATED
PHASE1/PHASE2
9 participants
through study completion, up to 7 months
2024-03-19
Participant Flow
Participant milestones
| Measure |
Bosutinib-Atezolizumab Combination
Drugs to be administered:
Bosutinib 400 MG/day Oral Tablet \[Bosulif 100mg oral tablets\] for 1 year Atezolizumab 1680 mg/28 days \[Tecentriq 840 MG in 14 ML Injection\] for 1 year
Bosutinib 400 MG Monotherapy: One cycle (28 days) only with bosutinib 400 mg/day therapy at the beginning of the trial + 12 cycles with bosutinib 400 mg/day therapy after combined therapy
Bosutinib 400 MG + Atezolizumab 840 MG in 14 ML Injection: 12 cycles with bosutinib 400 mg/day plus atezolizumab 1680 mg q4w therapy between the monotherapy bosutinib cycles
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|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Evaluation of Bosutinib Plus Atezolizumab in Newly Diagnosed Chronic Leukemia Adult Patients
Baseline characteristics by cohort
| Measure |
Bosutinib-Atezolizumab Combination
n=9 Participants
Drugs to be administered:
Bosutinib 400 MG/day Oral Tablet \[Bosulif 100mg oral tablets\] for 1 year Atezolizumab 1680 mg/28 days \[Tecentriq 840 MG in 14 ML Injection\] for 1 year
Bosutinib 400 MG Monotherapy: One cycle (28 days) only with bosutinib 400 mg/day therapy at the beginning of the trial + 12 cycles with bosutinib 400 mg/day therapy after combined therapy
Bosutinib 400 MG + Atezolizumab 840 MG in 14 ML Injection: 12 cycles with bosutinib 400 mg/day plus atezolizumab 1680 mg q4w therapy between the monotherapy bosutinib cycles
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|---|---|
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Age, Continuous
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47.8 years
STANDARD_DEVIATION 14.4 • n=93 Participants
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|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
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|
Sex: Female, Male
Male
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7 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
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8 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
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BCR-ABL
|
84.9707 IS (%)
STANDARD_DEVIATION 83.3527 • n=93 Participants
|
PRIMARY outcome
Timeframe: through study completion, up to 7 monthsPopulation: The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol for safety reasons were reached. Therefore no sufficient data were obtained to conduct an efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes.
All Adverse Events, despite their severity or causal relationship with the study medication, will be reported, graded according CTCAE v5.0 and analyzed.
Outcome measures
| Measure |
Bosutinib-Atezolizumab Combination
n=9 Participants
Drugs to be administered:
Bosutinib 400 MG/day Oral Tablet \[Bosulif 100mg oral tablets\] for 1 year Atezolizumab 1680 mg/28 days \[Tecentriq 840 MG in 14 ML Injection\] for 1 year
Bosutinib 400 MG Monotherapy: One cycle (28 days) only with bosutinib 400 mg/day therapy at the beginning of the trial + 12 cycles with bosutinib 400 mg/day therapy after combined therapy
Bosutinib 400 MG + Atezolizumab 840 MG in 14 ML Injection: 12 cycles with bosutinib 400 mg/day plus atezolizumab 1680 mg q4w therapy between the monotherapy bosutinib cycles
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|---|---|
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Safety Profile of Bosutinib 400 mg Daily in Combination With Atezolizumab in Participants With Chronic Myeloid Leukemia as First Line Treatments
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55 Total No Adverse events recorded
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SECONDARY outcome
Timeframe: 7 monthsPopulation: The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol were reached. Therefore no sufficient data were obtained to conduct the planned efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes. Study has to be prematurely terminated and the analysis could not be done due to lack of data (n=0 Participants).
Ratio of patients that reach a Molecular response
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 monthsPopulation: The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol were reached. Therefore no sufficient data were obtained to conduct the planned efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes. Study has to be prematurely terminated and the analysis could not be done due to lack of data (n=0 Participants).
Percentage of patients that remain alive at different time-points over the total number or patients
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 monthsPopulation: The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol were reached. Therefore no sufficient data were obtained to conduct the planned efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes. Study has to be prematurely terminated and the analysis could not be done due to lack of data (n=0 Participants).
Total number of patients that reach Molecular response 4 (MR4) and Molecular Response 4.5 (MR4.5)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 monthsPopulation: The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol were reached. Therefore no sufficient data were obtained to conduct the planned efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes. Study has to be prematurely terminated and the analysis could not be done due to lack of data (n=0 Participants).
Ratio of patients that reach MR4 and MR4.5
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 monthsPopulation: The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol were reached. Therefore no sufficient data were obtained to conduct the planned efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes. Study has to be prematurely terminated and the analysis could not be done due to lack of data (n=0 Participants).
Number of patients that reach a Complete Cytogenetic Responses (CCyR)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 monthsPopulation: The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol were reached. Therefore no sufficient data were obtained to conduct the planned efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes. Study has to be prematurely terminated and the analysis could not be done due to lack of data (n=0 Participants).
Ratio of patients that reach a Complete Cytogenetic Responses (CCyR)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 monthsPopulation: The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol were reached. Therefore no sufficient data were obtained to conduct the planned efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes. Study has to be prematurely terminated and the analysis could not be done due to lack of data (n=0 Participants).
Number of days lasted since the beginning of the treatment upt to reach molecular response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 monthsPopulation: The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol were reached. Therefore no sufficient data were obtained to conduct the planned efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes. Study has to be prematurely terminated and the analysis could not be done due to lack of data (n=0 Participants).
Average elapsed time measured for all included patients since the beginning of the treatment up until reach measurable cytogenetic or molecular response
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 monthsPopulation: The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol were reached. Therefore no sufficient data were obtained to conduct the planned efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes. Study has to be prematurely terminated and the analysis could not be done due to lack of data (n=0 Participants).
The overall estimated probability of reaching complete cytogenetic response or molecular response MMR, MR4 or MR4.5
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 monthsPopulation: The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol were reached. Therefore no sufficient data were obtained to conduct the planned efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes. Study has to be prematurely terminated and the analysis could not be done due to lack of data (n=0 Participants).
Number of the overall surviving patients
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 monthsPopulation: The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol were reached. Therefore no sufficient data were obtained to conduct the planned efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes. Study has to be prematurely terminated and the analysis could not be done due to lack of data (n=0 Participants).
The following events are considered disease progression: * Acelerated Phase. * Blast Crisis. * CML-related death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 monthsPopulation: The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol were reached. Therefore no sufficient data were obtained to conduct the planned efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes. Study has to be prematurely terminated and the analysis could not be done due to lack of data (n=0 Participants).
Number of the failure-free survival patients
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 monthsPopulation: The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol were reached. Therefore no sufficient data were obtained to conduct the planned efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes. Study has to be prematurely terminated and the analysis could not be done due to lack of data (n=0 Participants).
Number of the event-free survival patients
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 monthsPopulation: The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol were reached. Therefore no sufficient data were obtained to conduct the planned efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes. Study has to be prematurely terminated and the analysis could not be done due to lack of data (n=0 Participants).
Phenotypical assays of the cell characterization
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 monthsPopulation: The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol were reached. Therefore no sufficient data were obtained to conduct the planned efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes. Study has to be prematurely terminated and the analysis could not be done due to lack of data (n=0 Participants).
Phenotypical assays of the differentiation, maturation and proliferation NK cells markers
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 monthsPopulation: The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol were reached. Therefore no sufficient data were obtained to conduct the planned efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes. Study has to be prematurely terminated and the analysis could not be done due to lack of data (n=0 Participants).
Phenotypical assays of the CD4+ T cells activation markers
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 monthsPopulation: The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol were reached. Therefore no sufficient data were obtained to conduct the planned efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes. Study has to be prematurely terminated and the analysis could not be done due to lack of data (n=0 Participants).
Phenotypical markers assessment for relapse included 1. Cell characterization: NK cells (CD3- CD56+; CD16+ CD56+; TNFα; IFNα; Granzyme b NK-LGL cells (CD56+ CD57+), T-LGL cells (CD3+ CD57+), CD8 TCRα/β, NK markers (NKG2D, KIR2DL2/DL3/DS2, KIR2DL5B). 2. Differentiation and maturation (NKG2A/CD16) and proliferation (NK67) markers of NK cells. 3. CD4+ T cells activation markers: CD25 CD69 HLA-DR. 4. Predictive markers of CML relapse: T regs (CD4+ CD25int-hi CD127low), CD8+ T cells (PD-1/PD-L1) and plasmacytoid dendritic cells (CD86+).
Outcome measures
Outcome data not reported
Adverse Events
Bosutinib-Atezolizumab Combination
Serious adverse events
| Measure |
Bosutinib-Atezolizumab Combination
n=9 participants at risk
Drugs to be administered:
Bosutinib 400 MG/day Oral Tablet \[Bosulif 100mg oral tablets\] for 1 year Atezolizumab 1680 mg/28 days \[Tecentriq 840 MG in 14 ML Injection\] for 1 year
Bosutinib 400 MG Monotherapy: One cycle (28 days) only with bosutinib 400 mg/day therapy at the beginning of the trial + 12 cycles with bosutinib 400 mg/day therapy after combined therapy
Bosutinib 400 MG + Atezolizumab 840 MG in 14 ML Injection: 12 cycles with bosutinib 400 mg/day plus atezolizumab 1680 mg q4w therapy between the monotherapy bosutinib cycles
|
|---|---|
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Hepatobiliary disorders
Hepatotoxicity
|
22.2%
2/9 • Study Period: start (first patient enrolled) 24/02/2021 and premature end (Last patient last visit) 24/09/2021. Therefore, 7 months was the duration of this study and in this period of time when adverse event data were collected.
During the study all patients reported, at least 1 AE, and at least 1 AE considered possibly, probably or definitely related to the study medication. The system most frequently affected by AE, according to SOC MedDRA organization, was, Gastrointestinal Disorders, but the most severe AEs (grade 3 and above) were those affecting the liver function. All the possibly related events were previously described as adverse reactions in the product's data sheets (Bosulif SmPC and Tencentriq SmPC).
|
|
Hepatobiliary disorders
Cholestasis
|
11.1%
1/9 • Study Period: start (first patient enrolled) 24/02/2021 and premature end (Last patient last visit) 24/09/2021. Therefore, 7 months was the duration of this study and in this period of time when adverse event data were collected.
During the study all patients reported, at least 1 AE, and at least 1 AE considered possibly, probably or definitely related to the study medication. The system most frequently affected by AE, according to SOC MedDRA organization, was, Gastrointestinal Disorders, but the most severe AEs (grade 3 and above) were those affecting the liver function. All the possibly related events were previously described as adverse reactions in the product's data sheets (Bosulif SmPC and Tencentriq SmPC).
|
|
Hepatobiliary disorders
Transaminases Elevation
|
11.1%
1/9 • Study Period: start (first patient enrolled) 24/02/2021 and premature end (Last patient last visit) 24/09/2021. Therefore, 7 months was the duration of this study and in this period of time when adverse event data were collected.
During the study all patients reported, at least 1 AE, and at least 1 AE considered possibly, probably or definitely related to the study medication. The system most frequently affected by AE, according to SOC MedDRA organization, was, Gastrointestinal Disorders, but the most severe AEs (grade 3 and above) were those affecting the liver function. All the possibly related events were previously described as adverse reactions in the product's data sheets (Bosulif SmPC and Tencentriq SmPC).
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Other adverse events
| Measure |
Bosutinib-Atezolizumab Combination
n=9 participants at risk
Drugs to be administered:
Bosutinib 400 MG/day Oral Tablet \[Bosulif 100mg oral tablets\] for 1 year Atezolizumab 1680 mg/28 days \[Tecentriq 840 MG in 14 ML Injection\] for 1 year
Bosutinib 400 MG Monotherapy: One cycle (28 days) only with bosutinib 400 mg/day therapy at the beginning of the trial + 12 cycles with bosutinib 400 mg/day therapy after combined therapy
Bosutinib 400 MG + Atezolizumab 840 MG in 14 ML Injection: 12 cycles with bosutinib 400 mg/day plus atezolizumab 1680 mg q4w therapy between the monotherapy bosutinib cycles
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
77.8%
7/9 • Number of events 10 • Study Period: start (first patient enrolled) 24/02/2021 and premature end (Last patient last visit) 24/09/2021. Therefore, 7 months was the duration of this study and in this period of time when adverse event data were collected.
During the study all patients reported, at least 1 AE, and at least 1 AE considered possibly, probably or definitely related to the study medication. The system most frequently affected by AE, according to SOC MedDRA organization, was, Gastrointestinal Disorders, but the most severe AEs (grade 3 and above) were those affecting the liver function. All the possibly related events were previously described as adverse reactions in the product's data sheets (Bosulif SmPC and Tencentriq SmPC).
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
3/9 • Number of events 5 • Study Period: start (first patient enrolled) 24/02/2021 and premature end (Last patient last visit) 24/09/2021. Therefore, 7 months was the duration of this study and in this period of time when adverse event data were collected.
During the study all patients reported, at least 1 AE, and at least 1 AE considered possibly, probably or definitely related to the study medication. The system most frequently affected by AE, according to SOC MedDRA organization, was, Gastrointestinal Disorders, but the most severe AEs (grade 3 and above) were those affecting the liver function. All the possibly related events were previously described as adverse reactions in the product's data sheets (Bosulif SmPC and Tencentriq SmPC).
|
|
Gastrointestinal disorders
Nausea
|
44.4%
4/9 • Number of events 4 • Study Period: start (first patient enrolled) 24/02/2021 and premature end (Last patient last visit) 24/09/2021. Therefore, 7 months was the duration of this study and in this period of time when adverse event data were collected.
During the study all patients reported, at least 1 AE, and at least 1 AE considered possibly, probably or definitely related to the study medication. The system most frequently affected by AE, according to SOC MedDRA organization, was, Gastrointestinal Disorders, but the most severe AEs (grade 3 and above) were those affecting the liver function. All the possibly related events were previously described as adverse reactions in the product's data sheets (Bosulif SmPC and Tencentriq SmPC).
|
|
Musculoskeletal and connective tissue disorders
Abdominal discomfort
|
11.1%
1/9 • Number of events 1 • Study Period: start (first patient enrolled) 24/02/2021 and premature end (Last patient last visit) 24/09/2021. Therefore, 7 months was the duration of this study and in this period of time when adverse event data were collected.
During the study all patients reported, at least 1 AE, and at least 1 AE considered possibly, probably or definitely related to the study medication. The system most frequently affected by AE, according to SOC MedDRA organization, was, Gastrointestinal Disorders, but the most severe AEs (grade 3 and above) were those affecting the liver function. All the possibly related events were previously described as adverse reactions in the product's data sheets (Bosulif SmPC and Tencentriq SmPC).
|
|
Musculoskeletal and connective tissue disorders
Abdominal pain
|
11.1%
1/9 • Number of events 1 • Study Period: start (first patient enrolled) 24/02/2021 and premature end (Last patient last visit) 24/09/2021. Therefore, 7 months was the duration of this study and in this period of time when adverse event data were collected.
During the study all patients reported, at least 1 AE, and at least 1 AE considered possibly, probably or definitely related to the study medication. The system most frequently affected by AE, according to SOC MedDRA organization, was, Gastrointestinal Disorders, but the most severe AEs (grade 3 and above) were those affecting the liver function. All the possibly related events were previously described as adverse reactions in the product's data sheets (Bosulif SmPC and Tencentriq SmPC).
|
|
Musculoskeletal and connective tissue disorders
Abdominal pain upper
|
11.1%
1/9 • Number of events 1 • Study Period: start (first patient enrolled) 24/02/2021 and premature end (Last patient last visit) 24/09/2021. Therefore, 7 months was the duration of this study and in this period of time when adverse event data were collected.
During the study all patients reported, at least 1 AE, and at least 1 AE considered possibly, probably or definitely related to the study medication. The system most frequently affected by AE, according to SOC MedDRA organization, was, Gastrointestinal Disorders, but the most severe AEs (grade 3 and above) were those affecting the liver function. All the possibly related events were previously described as adverse reactions in the product's data sheets (Bosulif SmPC and Tencentriq SmPC).
|
|
Hepatobiliary disorders
Blood bilirubin increased
|
11.1%
1/9 • Number of events 1 • Study Period: start (first patient enrolled) 24/02/2021 and premature end (Last patient last visit) 24/09/2021. Therefore, 7 months was the duration of this study and in this period of time when adverse event data were collected.
During the study all patients reported, at least 1 AE, and at least 1 AE considered possibly, probably or definitely related to the study medication. The system most frequently affected by AE, according to SOC MedDRA organization, was, Gastrointestinal Disorders, but the most severe AEs (grade 3 and above) were those affecting the liver function. All the possibly related events were previously described as adverse reactions in the product's data sheets (Bosulif SmPC and Tencentriq SmPC).
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1 • Study Period: start (first patient enrolled) 24/02/2021 and premature end (Last patient last visit) 24/09/2021. Therefore, 7 months was the duration of this study and in this period of time when adverse event data were collected.
During the study all patients reported, at least 1 AE, and at least 1 AE considered possibly, probably or definitely related to the study medication. The system most frequently affected by AE, according to SOC MedDRA organization, was, Gastrointestinal Disorders, but the most severe AEs (grade 3 and above) were those affecting the liver function. All the possibly related events were previously described as adverse reactions in the product's data sheets (Bosulif SmPC and Tencentriq SmPC).
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9 • Number of events 1 • Study Period: start (first patient enrolled) 24/02/2021 and premature end (Last patient last visit) 24/09/2021. Therefore, 7 months was the duration of this study and in this period of time when adverse event data were collected.
During the study all patients reported, at least 1 AE, and at least 1 AE considered possibly, probably or definitely related to the study medication. The system most frequently affected by AE, according to SOC MedDRA organization, was, Gastrointestinal Disorders, but the most severe AEs (grade 3 and above) were those affecting the liver function. All the possibly related events were previously described as adverse reactions in the product's data sheets (Bosulif SmPC and Tencentriq SmPC).
|
|
General disorders
Pyrexia
|
11.1%
1/9 • Number of events 1 • Study Period: start (first patient enrolled) 24/02/2021 and premature end (Last patient last visit) 24/09/2021. Therefore, 7 months was the duration of this study and in this period of time when adverse event data were collected.
During the study all patients reported, at least 1 AE, and at least 1 AE considered possibly, probably or definitely related to the study medication. The system most frequently affected by AE, according to SOC MedDRA organization, was, Gastrointestinal Disorders, but the most severe AEs (grade 3 and above) were those affecting the liver function. All the possibly related events were previously described as adverse reactions in the product's data sheets (Bosulif SmPC and Tencentriq SmPC).
|
|
Metabolism and nutrition disorders
Lipase increased
|
11.1%
1/9 • Number of events 1 • Study Period: start (first patient enrolled) 24/02/2021 and premature end (Last patient last visit) 24/09/2021. Therefore, 7 months was the duration of this study and in this period of time when adverse event data were collected.
During the study all patients reported, at least 1 AE, and at least 1 AE considered possibly, probably or definitely related to the study medication. The system most frequently affected by AE, according to SOC MedDRA organization, was, Gastrointestinal Disorders, but the most severe AEs (grade 3 and above) were those affecting the liver function. All the possibly related events were previously described as adverse reactions in the product's data sheets (Bosulif SmPC and Tencentriq SmPC).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
1/9 • Number of events 1 • Study Period: start (first patient enrolled) 24/02/2021 and premature end (Last patient last visit) 24/09/2021. Therefore, 7 months was the duration of this study and in this period of time when adverse event data were collected.
During the study all patients reported, at least 1 AE, and at least 1 AE considered possibly, probably or definitely related to the study medication. The system most frequently affected by AE, according to SOC MedDRA organization, was, Gastrointestinal Disorders, but the most severe AEs (grade 3 and above) were those affecting the liver function. All the possibly related events were previously described as adverse reactions in the product's data sheets (Bosulif SmPC and Tencentriq SmPC).
|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
11.1%
1/9 • Number of events 2 • Study Period: start (first patient enrolled) 24/02/2021 and premature end (Last patient last visit) 24/09/2021. Therefore, 7 months was the duration of this study and in this period of time when adverse event data were collected.
During the study all patients reported, at least 1 AE, and at least 1 AE considered possibly, probably or definitely related to the study medication. The system most frequently affected by AE, according to SOC MedDRA organization, was, Gastrointestinal Disorders, but the most severe AEs (grade 3 and above) were those affecting the liver function. All the possibly related events were previously described as adverse reactions in the product's data sheets (Bosulif SmPC and Tencentriq SmPC).
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
11.1%
1/9 • Number of events 1 • Study Period: start (first patient enrolled) 24/02/2021 and premature end (Last patient last visit) 24/09/2021. Therefore, 7 months was the duration of this study and in this period of time when adverse event data were collected.
During the study all patients reported, at least 1 AE, and at least 1 AE considered possibly, probably or definitely related to the study medication. The system most frequently affected by AE, according to SOC MedDRA organization, was, Gastrointestinal Disorders, but the most severe AEs (grade 3 and above) were those affecting the liver function. All the possibly related events were previously described as adverse reactions in the product's data sheets (Bosulif SmPC and Tencentriq SmPC).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place