Trial Outcomes & Findings for Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation (NCT NCT03173248)
NCT ID: NCT03173248
Last Updated: 2025-11-10
Results Overview
EFS was defined as the time from randomization until treatment failure, relapse from remission, or death from any cause, whichever occurs first. Treatment failure was defined as failure to achieve complete remission (CR) by Week 24. CR: Bone marrow blasts \<5% and no Auer rods; absence of extramedullary disease; Absolute neutrophil count (ANC) ≥1.0 × 10\^9 per litre (10\^9/L) (1000 per microlitre \[1000/μL\]); platelet count ≥100 × 10\^9/L (100,000/μL); independence of red blood cell transfusions. Participants who had an EFS event (relapse or death) after, 2 or more missing disease assessments were censored at the last adequate disease assessment documenting no relapse before the missing assessments. The reported data represents the Kaplan-Meier median value.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
146 participants
Primary outcome timeframe
Up to Week 24
Results posted on
2025-11-10
Participant Flow
Participants took part in the study at 199 investigational sites from 19 March 2018 to 18 March 2021 (data cut off date). This study is ongoing. Results collected through data cut off date, 18 March 2021 are being reported.
A total of 146 participants with previously untreated isocitrate dehydrogenase 1 mutation-positive (IDH1m) acute myeloid leukemia (AML) were randomized into a 1:1 ratio to receive ivosidenib (AG-120) or AG-120 matched placebo in combination with azacitidine.
Participant milestones
| Measure |
AG-120 + Azacitidine
Participants received AG-120 500 mg orally, once daily (QD) in combination with azacitidine 75 milligrams per square meter per day (mg/m\^2/day) subcutaneously (SC) or intravenously (IV), on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.
|
Placebo + Azacitidine
Participants received AG-120 matching placebo orally, QD in combination with azacitidine 75 mg/m\^2/day SC or IV, on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
74
|
|
Overall Study
Safety Analysis Set
|
71
|
73
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
72
|
74
|
Reasons for withdrawal
| Measure |
AG-120 + Azacitidine
Participants received AG-120 500 mg orally, once daily (QD) in combination with azacitidine 75 milligrams per square meter per day (mg/m\^2/day) subcutaneously (SC) or intravenously (IV), on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.
|
Placebo + Azacitidine
Participants received AG-120 matching placebo orally, QD in combination with azacitidine 75 mg/m\^2/day SC or IV, on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.
|
|---|---|---|
|
Overall Study
Death
|
28
|
46
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
4
|
|
Overall Study
Ongoing at Data Cut-off Date: 18 March 2021
|
38
|
23
|
Baseline Characteristics
Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation
Baseline characteristics by cohort
| Measure |
AG-120 + Azacitidine
n=72 Participants
Participants received AG-120 500 mg orally, QD in combination with azacitidine 75 mg/m\^2/day SC or IV, on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.
|
Placebo + Azacitidine
n=74 Participants
Participants received AG-120 matching placebo orally, QD in combination with azacitidine 75 mg/m\^2/day SC or IV, on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.5 years
STANDARD_DEVIATION 6.18 • n=5 Participants
|
75.2 years
STANDARD_DEVIATION 7.39 • n=20 Participants
|
74.8 years
STANDARD_DEVIATION 6.81 • n=40 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
36 Participants
n=20 Participants
|
66 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
38 Participants
n=20 Participants
|
80 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
32 Participants
n=20 Participants
|
53 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
45 Participants
n=5 Participants
|
41 Participants
n=20 Participants
|
86 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
15 Participants
n=5 Participants
|
19 Participants
n=20 Participants
|
34 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
12 Participants
n=5 Participants
|
12 Participants
n=20 Participants
|
24 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · Not Reported
|
44 Participants
n=5 Participants
|
40 Participants
n=20 Participants
|
84 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Up to Week 24Population: FAS included all participants who were randomized.
EFS was defined as the time from randomization until treatment failure, relapse from remission, or death from any cause, whichever occurs first. Treatment failure was defined as failure to achieve complete remission (CR) by Week 24. CR: Bone marrow blasts \<5% and no Auer rods; absence of extramedullary disease; Absolute neutrophil count (ANC) ≥1.0 × 10\^9 per litre (10\^9/L) (1000 per microlitre \[1000/μL\]); platelet count ≥100 × 10\^9/L (100,000/μL); independence of red blood cell transfusions. Participants who had an EFS event (relapse or death) after, 2 or more missing disease assessments were censored at the last adequate disease assessment documenting no relapse before the missing assessments. The reported data represents the Kaplan-Meier median value.
Outcome measures
| Measure |
AG-120 + Azacitidine
n=72 Participants
Participants received AG-120 500 mg orally, QD in combination with azacitidine 75 mg/m\^2/day SC or IV, on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.
|
Placebo + Azacitidine
n=74 Participants
Participants received AG-120 matching placebo orally, QD in combination with azacitidine 75 mg/m\^2/day SC or IV, on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.
|
|---|---|---|
|
Event-Free Survival (EFS)
|
0.03 months
Interval 0.03 to 11.01
|
0.03 months
The upper and lower limit of 95% confidence interval (CI) were not estimable due to low number of participants with events.
|
SECONDARY outcome
Timeframe: Up to approximately 52 monthsCR rate is defined as the proportion of participants who achieve a CR. A Cochran-Mantel-Haenszel (CMH) test will be used to compare CR rate between the 2 treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsOS is defined as the time from date of randomization to the date of death due to any cause. Kaplan-Meier (KM) curves and KM estimates of OS will be presented for each treatment arm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsCR + CRh rate is defined as the proportion of participants who achieve a CR or CRh. CRh is defined as a CR with partial recovery of peripheral blood counts (less than 5% bone marrow blasts, absolute neutrophil count (ANC) greater than 0.5 × 10\^9/liter (L) 500/microliter (μL)\], and platelets greater than 50 × 10\^9/L \[50,000/μL\]). A CMH test will be used to compare the CR + CRh rate between the 2 treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsORR is defined as the rate of CR, CR with incomplete hematologic recovery (CRi) (including CR with incomplete platelet recovery \[CRp\]), partial remission (PR), and morphologic leukemia-free state (MLFS). The best response is calculated using the following hierarchy: CR, followed by CRi (including CRp), followed by PR and MLFS. A summary of best response by treatment arm will be produced. A CMH test will be used to compare ORR between the 2 treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsThe CR + CRi (including CRp) rate is defined as the proportion of participants who achieve a CR or CRi (including CRp). A CMH test will be used to compare the CR + CRi (including CRp) rate between the 2 treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsDOCR will be calculated as the date of the first occurrence of CR to the date of first documented disease relapse, or death. DOCR is only defined for participants who achieve a CR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsDOCRh will be calculated as the date of the first occurrence of CR or CRh to the date of first documented disease relapse or death. DOCRh is only defined for participants who achieve a CR or CRh.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsDOR will be calculated as the date of the first response to the date of first documented disease relapse, disease progression, or death. DOR is only defined for participants who achieve a CR, CRi (including CRp), PR, and/or MLFS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsDOCRi will be calculated as the date of the first occurrence of CR or CRi (including CRp) to the date of the first documented relapse or death. DOCRi is only defined for participants who achieve a CR or CRi (including CRp).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsTTCR will be assessed from the date of randomization to the date of first occurrence of CR. TTCR is only defined for participants who achieve a CR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsTTCRh will be assessed from the date of randomization to the date of first occurrence of CR or CRh. TTCRh is only defined for participants who achieve a CR or CRh.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsTTR will be assessed from the date of randomization to the date of the first response. TTR is only defined for participants who achieve a CR, CRi (including CRp), PR, and/or MLFS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsTTCRi will be assessed from the date of randomization to the date of first occurrence of CR or CRi (including CRp). TTCRi is only defined for participants who achieve a CR or CRi (including CRp).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsVital signs will include body temperature, respiratory rate, blood pressure, and heart rate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsLVEF is determined by ECHO or MUGA scan in participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsClinical laboratory assessments will include hematology, serum chemistry, coagulation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsAn AE is defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medicinal product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsAESIs are AEs that are not solicited local or systemic AEs, they are predefined AEs that required close monitoring and prompt reporting to the sponsor. AESIs include protocol-specified QT prolongation, isocitrate dehydrogenase (IDH) differentiation syndrome and leukocytosis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsAn SAE is defined as an untoward medical occurrence, significant hazard, contraindication, side effect or precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsAn AE is defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medicinal product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsParticipants receiving concomitant medications will be adequately monitored by ECG controls, drug concentration (where applicable), and serum electrolytes (i.e., potassium and magnesium).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsAll measures that are indicative of clinical benefit are measured like number of units of platelet and RBC infused.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsThe EORTC QLQ-C30 questionnaire measures quality of life and consists of 30 questions that are incorporated into 5 functional domains (physical, role, cognitive, emotional, and social); a global health status/global quality of life; 3 symptom scales (fatigue, pain, and nausea and vomiting); and 6 single items that assess additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and the perceived financial burden of treatment experienced by participants with cancer.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsThe EORTC EQ-5D-5L questionnaire measures quality of life and spans 5 dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, which are used to build a composite of the participant's health status.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsCR with IDH1 MC is defined as a response of CR where there is no evidence of the IDH1 mutation by molecular techniques to below the level of detection (0.02%-0.04%) for ≥1 on-treatment time point. A CMH test will be used to compare the rate of CR between 2 treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsThe number of doses administered, total dose, duration of treatment, dose intensity, and the proportion of participants with dose modifications, will be summarized by treatment arm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsSerial blood samples will be drawn before and after dosing of study treatment in order to determine circulating plasma concentrations.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 52 monthsSerial blood samples will be drawn before and after dosing of study treatment in order to determine circulating plasma concentrations.
Outcome measures
Outcome data not reported
Adverse Events
AG-120 + Azacitidine
Serious events: 49 serious events
Other events: 68 other events
Deaths: 27 deaths
Placebo + Azacitidine
Serious events: 60 serious events
Other events: 72 other events
Deaths: 45 deaths
Serious adverse events
| Measure |
AG-120 + Azacitidine
n=71 participants at risk
Participants received AG-120 500 mg orally, QD in combination with azacitidine 75 mg/m\^2/day SC or IV, on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.
|
Placebo + Azacitidine
n=73 participants at risk
Participants received AG-120 matching placebo orally, QD in combination with azacitidine 75 mg/m\^2/day SC or IV, on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.
|
|---|---|---|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Corynebacterium sepsis
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
2.7%
2/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Parotitis
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
2.7%
2/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Respiratory tract infection fungal
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
23.9%
17/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
27.4%
20/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.8%
2/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Blood and lymphatic system disorders
Bicytopenia
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Pneumonia
|
19.7%
14/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
21.9%
16/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
2.8%
2/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
2.7%
2/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
COVID-19
|
2.8%
2/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Appendicitis
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Bacterial sepsis
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Enterococcal infection
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Escherichia sepsis
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Infection
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Metapneumovirus infection
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Pneumonia fungal
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Pneumonia pseudomonal
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Pseudomonas infection
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Sepsis
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
4.1%
3/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Septic shock
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
2.7%
2/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Sinusitis
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Skin infection
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
2.7%
2/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
General disorders
Pyrexia
|
5.6%
4/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
4.1%
3/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
General disorders
Fatigue
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
General disorders
Pain
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
General disorders
General physical health deterioration
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
2.7%
2/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.2%
3/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.8%
2/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
2.7%
2/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Nervous system disorders
Haemorrhage intracranial
|
2.8%
2/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Nervous system disorders
Cerebral infarction
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Nervous system disorders
Cerebral ischaemia
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Nervous system disorders
Seizure
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Nervous system disorders
Dementia
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Gastrointestinal disorders
Diverticular perforation
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
2.7%
2/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Cardiac disorders
Atrial thrombosis
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Cardiac disorders
Cardiac failure
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Cardiac disorders
Pericardial effusion
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Renal and urinary disorders
Renal failure
|
2.8%
2/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Investigations
Blast cell count increased
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Investigations
Blood fibrinogen decreased
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Investigations
White blood cell count increased
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Investigations
Weight decreased
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
0.00%
0/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Eye disorders
Diplopia
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Differentiation syndrome
|
8.5%
6/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
Other adverse events
| Measure |
AG-120 + Azacitidine
n=71 participants at risk
Participants received AG-120 500 mg orally, QD in combination with azacitidine 75 mg/m\^2/day SC or IV, on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.
|
Placebo + Azacitidine
n=73 participants at risk
Participants received AG-120 matching placebo orally, QD in combination with azacitidine 75 mg/m\^2/day SC or IV, on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.
|
|---|---|---|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
6.8%
5/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
39.4%
28/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
26.0%
19/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
General disorders
Asthenia
|
15.5%
11/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
32.9%
24/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
General disorders
Chest discomfort
|
2.8%
2/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
5.5%
4/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
General disorders
Fatigue
|
12.7%
9/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
13.7%
10/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.6%
4/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
5.5%
4/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.7%
9/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
4.1%
3/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
General disorders
Injection site reaction
|
5.6%
4/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
6.8%
5/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
General disorders
Non-cardiac chest pain
|
5.6%
4/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
2.7%
2/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
General disorders
Oedema peripheral
|
11.3%
8/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
21.9%
16/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
General disorders
Pyrexia
|
32.4%
23/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
39.7%
29/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Oral candidiasis
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
6.8%
5/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Oral herpes
|
5.6%
4/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
4.1%
3/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Pneumonia
|
11.3%
8/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
12.3%
9/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
5.5%
4/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
4/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
4.1%
3/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Urinary tract infection
|
4.2%
3/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
9.6%
7/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
4.2%
3/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
5.5%
4/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
5.5%
4/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Investigations
Blood creatinine increased
|
5.6%
4/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
4.1%
3/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Investigations
C-reactive protein increased
|
4.2%
3/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
5.5%
4/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Investigations
Electrocardiogram QT prolonged
|
19.7%
14/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
6.8%
5/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Investigations
Neutrophil count decreased
|
8.5%
6/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
6.8%
5/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Investigations
Platelet count decreased
|
11.3%
8/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
8.2%
6/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Investigations
Weight decreased
|
5.6%
4/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
15.1%
11/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.5%
11/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
26.0%
19/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
8.2%
6/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.6%
4/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
2.7%
2/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.8%
2/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
9.6%
7/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
5.5%
4/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.5%
11/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
28.8%
21/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.0%
5/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
6.8%
5/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.0%
5/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
9.6%
7/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.8%
2/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
6.8%
5/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.3%
8/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
4.1%
3/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.5%
6/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
2.7%
2/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Differentiation syndrome
|
7.0%
5/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
6.8%
5/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Nervous system disorders
Dizziness
|
9.9%
7/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
4.1%
3/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Nervous system disorders
Dysgeusia
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
5.5%
4/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Nervous system disorders
Headache
|
11.3%
8/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
2.7%
2/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Nervous system disorders
Syncope
|
7.0%
5/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
5.5%
4/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Psychiatric disorders
Anxiety
|
7.0%
5/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
4.1%
3/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Psychiatric disorders
Confusional state
|
7.0%
5/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
6.8%
5/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
5.5%
4/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Psychiatric disorders
Insomnia
|
18.3%
13/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
12.3%
9/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.2%
3/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
6.8%
5/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.5%
6/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
15.1%
11/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.5%
11/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
12.3%
9/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.9%
7/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
6.8%
5/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.5%
6/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.8%
2/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
8.2%
6/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.6%
4/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
2.7%
2/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.5%
6/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
4.1%
3/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
5.6%
4/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.9%
7/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
5.5%
4/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.5%
6/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
12.3%
9/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
5.5%
4/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Vascular disorders
Haematoma
|
12.7%
9/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Vascular disorders
Hypertension
|
9.9%
7/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
5.5%
4/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Vascular disorders
Hypotension
|
5.6%
4/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
6.8%
5/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.0%
5/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
9.6%
7/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Gastrointestinal disorders
Nausea
|
42.3%
30/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
38.4%
28/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Gastrointestinal disorders
Proctalgia
|
1.4%
1/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
6.8%
5/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
31.0%
22/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
28.8%
21/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
9.9%
7/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
12.3%
9/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
11.3%
8/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
1.4%
1/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.5%
6/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
2.7%
2/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
28.2%
20/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
16.4%
12/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
28.2%
20/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
19.2%
14/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.5%
6/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
9.6%
7/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Gastrointestinal disorders
Constipation
|
26.8%
19/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
52.1%
38/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
35.2%
25/71 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
34.2%
25/73 • 3 years
SAS included all participants who received at least 1 dose of the study treatment.
|
Additional Information
Clinical Studies Department
Institut de Recherches Internationales Servier (I.R.I.S.)
Phone: +33155726000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60