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Study AG120-C-009 is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 (ivosidenib) + azacitidine vs placebo + azacitidine in adult participants with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy. The primary endpoint is event-free survival (EFS). The key secondary efficacy endpoints are overall survival (OS), rate of complete remission (CR), rate of CR and complete remission with partial hematologic recovery (CRh), and overall response rate (ORR). Participants eligible for study treatment based on Screening assessments will be randomized 1:1 to receive oral AG-120 or matched placebo, both administered in combination with subcutaneous (SC) or intravenous (IV) azacitidine. An estimated 200 participants will take part in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AG-120 + Azacitidine | Experimental | 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. |
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| Placebo + Azacitidine | Placebo Comparator | 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 . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AG-120 | Drug | Tablets administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Event-Free Survival (EFS) | 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. | Up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission Rate (CR Rate) | CR 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. | Up to approximately 52 months |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norton Cancer Institute - Suburban | Louisville | Kentucky | 40207 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35443108 | Background | Montesinos P, Recher C, Vives S, Zarzycka E, Wang J, Bertani G, Heuser M, Calado RT, Schuh AC, Yeh SP, Daigle SR, Hui J, Pandya SS, Gianolio DA, de Botton S, Dohner H. Ivosidenib and Azacitidine in IDH1-Mutated Acute Myeloid Leukemia. N Engl J Med. 2022 Apr 21;386(16):1519-1531. doi: 10.1056/NEJMoa2117344. | |
| 40706052 | Derived |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.
Access can be requested for all interventional clinical studies:
In addition, access can be requested for all interventional clinical studies in patients:
After Marketing Authorisation in EEA or US if the study is used for the approval.
Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 7, 2021 | Jan 25, 2023 |
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| Placebo | Drug | Tablets administered orally |
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| Azacitidine | Drug | Administered SC or IV |
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OS 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. |
| Up to approximately 52 months |
| CR + Complete Remission With Partial Hematologic (CRh) Rate | CR + 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. | Up to approximately 52 months |
| Objective Response Rate (ORR) | ORR 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. | Up to approximately 52 months |
| CR + CRi (Including CRp) Rate | The 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. | Up to approximately 52 months |
| Duration of CR (DOCR) | DOCR 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. | Up to approximately 52 months |
| Duration of CRh (DOCRh) | DOCRh 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. | Up to approximately 52 months |
| Duration of Response (DOR) | DOR 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. | Up to approximately 52 months |
| Duration of CRi (DOCRi) | DOCRi 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). | Up to approximately 52 months |
| Time to CR (TTCR) | TTCR 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. | Up to approximately 52 months |
| Time to CRh (TTCRh) | TTCRh 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. | Up to approximately 52 months |
| Time to Response (TTR) | TTR 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. | Up to approximately 52 months |
| Time to CRi (TTCRi) | TTCRi 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). | Up to approximately 52 months |
| Percentage of Participants With Abnormalities in Vital Sign Measurements | Vital signs will include body temperature, respiratory rate, blood pressure, and heart rate. | Up to approximately 52 months |
| Percentage of Participants With Abnormalities in Eastern Cooperative Oncology Group Performance Status (ECOG PS) | Up to approximately 52 months |
| Percentage of Participants With Abnormalities in 12-lead Electrocardiograms (ECGs) | Up to approximately 52 months |
| Percentage of Participants With Abnormalities in Echocardiogram (ECHO) or Multi-Gated Acquisition (MUGA) for Left Ventricular Ejection Fraction (LVEF) | LVEF is determined by ECHO or MUGA scan in participants. | Up to approximately 52 months |
| Percentage of Participants With Abnormalities in Clinical Laboratory Tests | Clinical laboratory assessments will include hematology, serum chemistry, coagulation. | Up to approximately 52 months |
| Percentage of Participants With Adverse Events (AEs) | An 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. | Up to approximately 52 months |
| Percentage of Participants With AEs of Special Interest (AESIs) | AESIs 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. | Up to approximately 52 months |
| Percentage of Participants With Serious Adverse Events (SAEs) | An 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. | Up to approximately 52 months |
| Percentage of Participants With Adverse Events Leading to Discontinuation or Death | An 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. | Up to approximately 52 months |
| Percentage of Participants Using Concomitant Medications | Participants receiving concomitant medications will be adequately monitored by ECG controls, drug concentration (where applicable), and serum electrolytes (i.e., potassium and magnesium). | Up to approximately 52 months |
| Units of Platelets and Red Blood Cells (RBC) Infused | All measures that are indicative of clinical benefit are measured like number of units of platelet and RBC infused. | Up to approximately 52 months |
| Rate of Infection | Up to approximately 52 months |
| Number of Days Spent Hospitalized | Up to approximately 52 months |
| Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) QLC-C30 Questionnaire | The 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. | Up to approximately 52 months |
| Change From Baseline in the EORTC EQ-5D-5L Questionnaire | The 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. | Up to approximately 52 months |
| Percentage of Participants With CR With IDH1 Mutation Clearance (MC) | CR 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. | Up to approximately 52 months |
| Percentage of Participants With Drug Exposure, Dose Modifications and Dose Intensities | The 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. | Up to approximately 52 months |
| Circulating Plasma Concentration of AG-120 | Serial blood samples will be drawn before and after dosing of study treatment in order to determine circulating plasma concentrations. | Up to approximately 52 months |
| Circulating Plasma Concentration of 2-HG | Serial blood samples will be drawn before and after dosing of study treatment in order to determine circulating plasma concentrations. | Up to approximately 52 months |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia |
| Salzburger Landeskliniken | Salzburg | 5020 | Austria |
| Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel | Vienna | 1130 | Austria |
| Unicamp Universidade Estadual de Campinas | Campinas | São Paulo | 13083-878 | Brazil |
| Hospital Amaral Carvalho | Jaú | São Paulo | 17210-120 | Brazil |
| Instituto Nacional de Cancer | Rio de Janeiro | 20230-130 | Brazil |
| Hospital Sirio Libanes | São Paulo | 01308-050 | Brazil |
| Hospital Sao Jose | São Paulo | 01321-001 | Brazil |
| Hospital Santa Marcelina | São Paulo | 08270-070 | Brazil |
| Cancer Care Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| University Health Network | Toronto | Ontario | M5G 2M9 | Canada |
| Henan Cancer Hospital | Zhengzhou | Henan | 450008 | China |
| West China Hospital Sichuan University | Chengdu | Sichuan | 610041 | China |
| Peking Union Medical College Hospital | Beijing | China |
| Guangdong Provincial People's Hospital | Guangzhou | 510080 | China |
| The First Affiliated Hospital, College of Medicine, Zhejiang University | Hangzhou | 310003 | China |
| Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences | Tianjin | 300020 | China |
| Fakultni nemocnice Ostrava | Ostrava | Czechia |
| Hopital Haut Leveque | Pessac | Gironde | 33604 | France |
| Hopital Bretonneau | Tours | Indre-et-Loire | 37044 | France |
| Hotel Dieu - Nantes | Nantes | Loire-Atlantique | 44093 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | Rhone | 69495 | France |
| Centre Hospitalier Le Mans | Le Mans | Sarthe | 72037 | France |
| CHRU de Brest - Hopital Morvan | Brest | 29609 | France |
| Institut dHematologie de Basse Normandie | Caen | 14000 | France |
| CHU de Grenoble | Grenoble | 38043 | France |
| Centre Hospitalier de Versailles CHV Hopital Andre Mignot | Le Chesnay | 78 157 | France |
| Groupe Hospitalier Necker Enfants Malades | Paris | 75015 | France |
| CHRU de Poitiers La Miletrie | Poitiers | 86021 | France |
| Hopital de Hautepierre | Strasbourg | 67200 | France |
| EDOG - Institut Claudius Regaud - PPDS | Toulouse | 31059 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Universitatsklinikum Essen | Essen | North Rhine-Westphalia | 45122 | Germany |
| Klinikum Chemnitz gGmbH | Chemnitz | Saxony | 09113 | Germany |
| Charite - Universitatsmedizin Berlin | Berlin | 13353 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Universitatsklinikum Leipzig | Leipzig | 04103 | Germany |
| LMU Klinikum der Universitat Munchen | München | 81377 | Germany |
| Universitatsklinikum Ulm | Ulm | 89081 | Germany |
| Rabin Medical Center - PPDS | Petah Tikva | 49100 | Israel |
| Kaplan Medical Center | Rehovot | 7610000 | Israel |
| Shamir Medical Center Assaf Harofeh | Tzrifin | 70300 | Israel |
| ASST dei Sette Laghi - Ospedale Di Circolo E Fondazione Macchi | Varese | Lombardy | 21100 | Italy |
| Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS | Meldola | 47014 | Italy |
| Ospedale San Raffaele S.r.l. - PPDS | Milan | 20132 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda | Milan | 20162 | Italy |
| Fondazione IRCCS Policlinico San Matteo di Pavia | Pavia | 27100 | Italy |
| Ospedale Infermi di Rimini | Rimini | 47900 | Italy |
| Azienda Ospedaliera Citta della Salute e della Scienza di Torino | Torino | 10126 | Italy |
| Matsuyama Red Cross Hospital | Matsuyama | Ehime | 790-8524 | Japan |
| University of Fukui Hospital | Fukui | 910-1193 | Japan |
| Japanese Red Cross Society Himeji Hospital | Himeji | 670-8540 | Japan |
| Kobe City Medical Center General Hospital | Kobe | Japan |
| SINACOR | Culiacán | 80230 | Mexico |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | México | 14000 | Mexico |
| VU Medisch Centrum | Amsterdam | North Holland | 1081 HV | Netherlands |
| Universitair Medisch Centrum Groningen | Nijmegen | 6525 GA | Netherlands |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu | Wroclaw | Lower Silesian Voivodeship | 50-367 | Poland |
| Instytut Hematologii i Transfuzjologii | Warsaw | Masovian Voivodeship | 02-776 | Poland |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80-214 | Poland |
| Kaluga Regional Clinical Hospital | Kaluga | 248007 | Russia |
| City Clinical Hospital # 40 | Moscow | 129301 | Russia |
| National Cancer Center | Goyang-si | Gyeonggido | 10408 | South Korea |
| Ajou University Hospital | Suwon | Gyeonggido | 16499 | South Korea |
| Pusan National University Hospital | Busan | 602-739 | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | 03722 | South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| CHUS H. Clinico U. de Santiago | Santiago de Compostela | A Coruna | 15706 | Spain |
| Hospital Universitario Son Espases | Palma de Mallorca | Balearic Islands | 07010 | Spain |
| Hospital Universitario Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital Universitario de Gran Canaria Doctor Negrin | Las Palmas de Gran Canaria | Las Palmas | 35010 | Spain |
| Hospital Universitario Vall d'Hebron - PPDS | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario Virgen del Rocio - PPDS | Seville | 41013 | Spain |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | 46026 | Spain |
| Hospital Clinico Universitario Lozano Blesa | Zaragoza | 50009 | Spain |
| Changhua Christian Medical Foundation Changhua Christian Hospital | Changhua | 500 | Taiwan |
| Kaohsiung Medical University Hospital | Kaohsiung City | 807 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Chi Mei Medical Center, Liouying | Tainan | 736 | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Birmingham Heartlands Hospital | Birmingham | West Midlands | B9 5SS | United Kingdom |
| Montesinos P, Marchione DM, Recher C, Heuser M, Vives S, Zarzycka E, Wang J, Riva M, Calado RT, Schuh AC, Yeh SP, Tron AE, Hui J, Gianolio DA, Choe S, Patel P, De Botton S, DiNardo CD, Dohner H. Long-term results from the AGILE study of azacitidine plus ivosidenib vs placebo in newly diagnosed IDH1-mutated AML. Blood Adv. 2025 Oct 28;9(20):5177-5189. doi: 10.1182/bloodadvances.2025016399. |
| 38010220 | Derived | Woods A, Norsworthy KJ, Wang X, Vallejo J, Chiu Yuen Chow E, Li RJ, Sun J, Charlab R, Jiang X, Pazdur R, Theoret MR, de Claro RA. FDA Approval Summary: Ivosidenib in Combination with Azacitidine for Treatment of Patients with Newly Diagnosed Acute Myeloid Leukemia with an IDH1 Mutation. Clin Cancer Res. 2024 Apr 1;30(7):1226-1231. doi: 10.1158/1078-0432.CCR-23-2234. |
| Study Protocol | View IPD |
| Statistical Analysis Plan | View IPD |
| Informed Consent Form | View IPD |
| Clinical Study Report | View IPD |
| Study-level clinical trial data | View IPD |
| FG001 | 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. |
| Safety Analysis Set | Safety Analysis Set (SAS) included all participants who received at least 1 dose of the study treatment. |
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| COMPLETED |
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| NOT COMPLETED |
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FAS included all participants who were randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AG-120 + Azacitidine | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Event-Free Survival (EFS) | 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. | FAS included all participants who were randomized. | Posted | Median | 95% Confidence Interval | months | Up to Week 24 |
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| Secondary | Complete Remission Rate (CR Rate) | CR 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. | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS 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. | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | CR + Complete Remission With Partial Hematologic (CRh) Rate | CR + 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. | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | ORR 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. | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | CR + CRi (Including CRp) Rate | The 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. | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of CR (DOCR) | DOCR 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. | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of CRh (DOCRh) | DOCRh 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. | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR 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. | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of CRi (DOCRi) | DOCRi 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). | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to CR (TTCR) | TTCR 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. | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to CRh (TTCRh) | TTCRh 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. | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) | TTR 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. | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to CRi (TTCRi) | TTCRi 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). | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Abnormalities in Vital Sign Measurements | Vital signs will include body temperature, respiratory rate, blood pressure, and heart rate. | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Abnormalities in Eastern Cooperative Oncology Group Performance Status (ECOG PS) | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Abnormalities in 12-lead Electrocardiograms (ECGs) | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Abnormalities in Echocardiogram (ECHO) or Multi-Gated Acquisition (MUGA) for Left Ventricular Ejection Fraction (LVEF) | LVEF is determined by ECHO or MUGA scan in participants. | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Abnormalities in Clinical Laboratory Tests | Clinical laboratory assessments will include hematology, serum chemistry, coagulation. | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events (AEs) | An 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. | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With AEs of Special Interest (AESIs) | AESIs 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. | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Serious Adverse Events (SAEs) | An 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. | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events Leading to Discontinuation or Death | An 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. | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Using Concomitant Medications | Participants receiving concomitant medications will be adequately monitored by ECG controls, drug concentration (where applicable), and serum electrolytes (i.e., potassium and magnesium). | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Units of Platelets and Red Blood Cells (RBC) Infused | All measures that are indicative of clinical benefit are measured like number of units of platelet and RBC infused. | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Infection | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Days Spent Hospitalized | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) QLC-C30 Questionnaire | The 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. | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the EORTC EQ-5D-5L Questionnaire | The 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. | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With CR With IDH1 Mutation Clearance (MC) | CR 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. | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Drug Exposure, Dose Modifications and Dose Intensities | The 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. | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Circulating Plasma Concentration of AG-120 | Serial blood samples will be drawn before and after dosing of study treatment in order to determine circulating plasma concentrations. | Not Posted | Jun 2027 | Up to approximately 52 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Circulating Plasma Concentration of 2-HG | Serial blood samples will be drawn before and after dosing of study treatment in order to determine circulating plasma concentrations. | Not Posted | Jun 2027 | Up to approximately 52 months | Participants |
3 years
SAS included all participants who received at least 1 dose of the study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AG-120 + Azacitidine | 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. | 27 | 71 | 49 | 71 | 68 | 71 |
| EG001 | 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. | 45 | 73 | 60 | 73 | 72 | 73 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Metapneumovirus infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Corynebacterium sepsis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Enterococcal sepsis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Respiratory tract infection fungal | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Bicytopenia | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Differentiation syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Neutropenic colitis | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Blast cell count increased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Blood fibrinogen decreased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Suspected COVID-19 | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Differentiation syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Studies Department | Institut de Recherches Internationales Servier (I.R.I.S.) | +33155726000 | scientificinformation@servier.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 23, 2020 | Jan 25, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000627630 | ivosidenib |
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| White |
|
| Black or African American |
|
| Other |
|
| Not Reported |
|