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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005124-15 | EudraCT Number |
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This study aimed to assess the optimal duration of nilotinib 300 mg twice daily (BID) consolidation treatment in patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), in order that patients remained in treatment-free remission (≥MR4.0) without molecular relapse 12 months after starting the Treatment-Free Remission (TFR) phase.
This was a prospective, randomized, open-label, multicenter Phase III study. The study design was made up of 3 phases:
Subjects were enrolled into the study and were treated with nilotinib 300mg twice daily (BID) for 24 months, during the induction (12 months) and consolidation (12 months) phases. At the end of the first 24 months of treatment, participants achieving a sustained molecular response (defined as ≥ MR4.0, in 4 out of 5 real-time quantitative polymerase chain reaction (RQ-PCR) assessments, including the last assessment, in the last 12 months) were randomized on a 1:1 basis to either:
Participants not achieving a sustained molecular response at 24 months from treatment start were not eligible for randomization and were treated at the discretion of the investigator according to standard practice. Information on survival, stem cell transplantation, and status of the patient's disease was collected until death or until 5 years from study entry, whichever came first. Additionally, for Nilotinib 36-month treatment arm, participants who did not achieve a sustained molecular response at 36 months from treatment start, discontinued from the study and were treated according to standard practice and followed up until death or until 5 years from study entry, whichever came first.
Participants relapsing during the TFR phase entered the nilotinib re-treatment phase of the study, and were re-treated with the same dose of nilotinib as they were on before the TFR phase. These patients remained on study until the completion of the 5-year study period unless prematurely withdrawn and discontinued from the study for any reason specified in the Protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nilotinib 24-month treatment | Experimental | Participants were treated with nilotinib 300mg BID for 24 months and, thereafter, entered the 36-month TFR phase |
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| Nilotinib 36-month treatment | Experimental | Participants were treated with nilotinib 300mg BID for 36 months and, thereafter, entered the 24-month TFR phase |
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| Not randomized | Experimental | Participants were treated with nolotinib 300mg BID for 24 months, but did not achieve a sustained molecular response after 24 months of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nilotinib | Drug | Participants received a daily oral nilotinib dose of 300 mg BID, given as two 150 mg capsules BID. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Remained in Treatment Free Remission (TFR) Without Molecular Relapse 12 Months After Entering the TFR Phase | Number of participants who remained in TFR (≥molecular response (MR) 4.0) without molecular relapse 12 months after entering the TFR phase (without re-starting nilotinib therapy) divided by the number of participants who entered the TFR phase and multiplied by 100. Molecular relapse during TFR is defined as the loss of major molecular response (MMR), or the confirmed loss of MR4.0 (defined by 3 consecutive tests less than MR4.0 assessed at 3 consecutive visits during TFR phase). Participants dropping out early from the study during the TFR phase were considered as unsuccessful TFR. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MMR is defined as≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1% BCR-ABL. MR4.0 is defined as either detectable disease≤0.01% BCR-ABL or undetectable disease in cDNA with≥10,000 ABL transcripts | 12 months after entering the TFR phase, which is after 36 months from study treatment start for Nilotinib 24-month treatment arm and after 48 months from study treatment start for Nilotinib 36-month treatment arm |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Incidence of MMR During the Pre-randomization Induction/Consolidation Phase Among Participants Without That Response at Study Entry | Number of participants who were in MMR during pre-randomization induction/consolidation phase divided by the number of participants without that response at baseline and multiplied by 100. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MMR is defined as ≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1% BCR-ABL. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Other inclusion/exclusion criteria might apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Linz | Upper Austria | A 4020 | Austria | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34123791 | Derived | Borghi L, Rosti G, Maggi A, Breccia M, Di Bona E, Iurlo A, La Barba G, Sportoletti P, Albano F, Galimberti S, Rivellini F, Cambrin GR, Capodanno I, Cuneo A, Bonifacio M, Sica S, Arcaini L, Capochiani E, Minotto C, Ciceri F, Crugnola M, Di Caprio L, Supekar S, Elena C, Baccarani M, Vegni E. Perspectives and Emotional Experiences of Patients With Chronic Myeloid Leukemia During ENESTPath Clinical Trial and Treatment-Free Remission: Rationale and Protocol of the Italian Substudy. Front Oncol. 2021 May 26;11:638689. doi: 10.3389/fonc.2021.638689. eCollection 2021. |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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For one participant randomized to Nilotinib 36-month treatment arm, the informed consent was not obtained prior to any study specific procedure. This participant discontinued the study before entering the TFR phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nilotinib 24-month Treatment | Participants were treated with nilotinib 300mg BID for 24 months and, thereafter, entered the 36-month TFR phase |
| FG001 | Nilotinib 36-month Treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Phase |
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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 | Jun 1, 2016 | Jun 23, 2021 |
All participants received 24 months of study treatment. After 24 months of treatment, eligible participants (i.e. those deemed to have achieved sustained molecular response) were randomized to one of the two study arms on a continued open-label basis.
Participants not achieving sustained molecular response after 24 months of treatment were not randomized but remained in the study until the 5-year study period was completed (Not randomized arm).
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| From baseline up to 24 months after study treatment start |
| Cumulative Incidence of MMR During the Post-randomization Consolidation Phase Among Participants Without That Response at Study Entry | Number of participants who were in MMR during post-randomization consolidation phase divided by the number of participants without that response at baseline and multiplied by 100. Post-randomization consolidation phase corresponded to the 12-month additional treatment (after randomization) for Nilotinib 36-month treatment arm. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MMR is defined as ≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1% BCR-ABL. | From randomization (month 24 after study treatment start) up to 36 months after study treatment start |
| Cumulative Incidence of MR4.0 During the Pre-randomization Induction/Consolidation Phase Among Participants Without That Response at Study Entry | Number of participants who were in MR4.0 during the pre-randomization induction/consolidation phase divided by the number of participants without that response at baseline and multiplied by 100. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.0 is defined as either detectable disease ≤0.01% BCR-ABL IS or undetectable disease in cDNA with ≥10,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL) | From baseline up to 24 months after study treatment start |
| Cumulative Incidence of MR4.0 During the Post-randomization Consolidation Phase Among Participants Without That Response at Study Entry | Number of participants who were in MR4.0 during the post-randomization consolidation phase divided by the number of participants without that response at baseline and multiplied by 100. Post-randomization consolidation phase corresponded to the 12-month additional treatment (after randomization) for Nilotinib 36-month treatment arm. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.0 is defined as either detectable disease ≤0.01% BCR-ABL IS or undetectable disease in cDNA with ≥10,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL) | From randomization (month 24 after study treatment start) up to 36 months after study treatment start |
| Cumulative Incidence of MR4.5 During the Pre-randomization Induction/Consolidation Phase Among Participants Without That Response at Study Entry | Number of participants who were in MR4.5 during the pre-randomization induction/consolidation phase divided by the number of participants without that response at baseline and multiplied by 100. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.5 is defined as either detectable disease ≤ 0.0032% BCR-ABL IS; or undetectable disease within cDNA with ≥ 32,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL) | From baseline up to 24 months after study treatment start |
| Cumulative Incidence of MR4.5 During the Post-randomization Consolidation Phase Among Participants Without That Response at Study Entry | Number of participants who were in MR4.5 during the post-randomization consolidation phase divided by the number of participants without that response at baseline and multiplied by 100. Post-randomization consolidation phase corresponded to the 12-month additional treatment (after randomization) for Nilotinib 36-month treatment arm. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.5 is defined as either detectable disease ≤ 0.0032% BCR-ABL IS; or undetectable disease within cDNA with ≥ 32,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL) | From randomization (month 24 after study treatment start) up to 36 months after study treatment start |
| Cumulative Incidence of MMR During the Pre-randomization Induction/Consolidation Phase | Number of participants who were in MMR during the pre-randomization induction/consolidation phase divided by the number of enrolled participants and multiplied by 100. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MMR is defined as ≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1% BCR-ABL. | From baseline up to 24 months after study treatment start |
| Cumulative Incidence of MMR During the Post-randomization Consolidation Phase | Number of participants who were in MMR during the post-randomization consolidation phase divided by the number of enrolled participants and multiplied by 100. Post-randomization consolidation phase corresponded to the 12-month additional treatment (after randomization) for Nilotinib 36-month treatment arm. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MMR is defined as ≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1% BCR-ABL. | From randomization (month 24 after study treatment start) up to 36 months after study treatment start |
| Cumulative Incidence of MR4.0 During the Pre-randomization Induction/Consolidation Phase | Number of participants who were in MR4.0 during the pre-randomization induction/consolidation phase divided by the number of enrolled participants and multiplied by 100. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.0 is defined as either detectable disease ≤0.01% BCR-ABL IS or undetectable disease in cDNA with ≥10,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL) | From baseline up to 24 months after study treatment start |
| Cumulative Incidence of MR4.0 During the Post-randomization Consolidation Phase | Number of participants who were in MR4.0 during the post-randomization consolidation phase divided by the number of enrolled participants and multiplied by 100. Post-randomization consolidation phase corresponded to the 12-month additional treatment (after randomization) for Nilotinib 36-month treatment arm. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.0 is defined as either detectable disease ≤0.01% BCR-ABL IS or undetectable disease in cDNA with ≥10,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL) | From randomization (month 24 after study treatment start) up to 36 months after study treatment start |
| Cumulative Incidence of MR4.5 During the Pre-randomization Induction/Consolidation Phase | Number of participants who were in MR4.5 during the pre-randomization induction/consolidation phase divided by the number of enrolled participants and multiplied by 100. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.5 is defined as either detectable disease ≤ 0.0032% BCR-ABL IS; or undetectable disease within cDNA with ≥ 32,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL) | From baseline up to 24 months after study treatment start |
| Cumulative Incidence of MR4.5 During the Post-randomization Consolidation Phase | Number of participants who were in MR4.5 during the post-randomization consolidation phase divided by the number of enrolled participants and multiplied by 100. Post-randomization consolidation phase corresponded to the 12-month additional treatment (after randomization) for Nilotinib 36-month treatment arm. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.5 is defined as either detectable disease ≤ 0.0032% BCR-ABL IS; or undetectable disease within cDNA with ≥ 32,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL) | From randomization (month 24 after study treatment start) up to 36 months after study treatment start |
| Percentage of Participants Who Were in MMR During TFR Phase | Number of participants who were in MMR at selected timepoints divided by the number of participants in the TFR phase and multiplied by 100. Participants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotinib 24-month treatment arm had a maximum of 36 months of TFR phase. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MMR is defined as ≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1% BCR-ABL. | From Month 1 after entering TFR phase up to 24 months after entering TFR phase for Nilotinib 36-month treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-month treatment arm |
| Percentage of Participants Who Were in MR4.0 During the TFR Phase | Number of participants who were in MR4.0 at selected timepoints divided by the number of participants in the TFR phase and multiplied by 100. Participants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotinib 24-month treatment arm had a maximum of 36 months of TFR phase. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.0 is defined as either detectable disease ≤0.01% BCR-ABL IS or undetectable disease in cDNA with ≥10,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL) | From Month 1 after entering TFR phase up to 24 months after entering TFR phase for Nilotininb 36-months treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-months treatment arm |
| Percentage of Participants Who Were in MR4.5 During the TFR Phase | Number of participants who were in MR4.5 at selected timepoints divided by the number of participants in the TFR phase and multiplied by 100. Participants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotinib 24-month treatment arm had a maximum of 36 months of TFR phase. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.5 is defined as either detectable disease ≤ 0.0032% BCR-ABL IS; or undetectable disease within cDNA with ≥ 32,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL) | From Month 1 after entering TFR phase up to 24 months after entering TFR phase for Nilotininb 36-month treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-month treatment arm |
| BCR-ABL Ratio (Expressed as a Percentage) During the Induction/Consolidation Phase | BCR-ABL transcript ratio by international scale (IS) (expressed as a percentage) during the induction/consolidation phase. Participants randomized to Nilotinib 36-month treatment arm had 12-month additional consolidation phase (post-randomization). | From baseline up to 24 months after study treatment start for Nilotinib 24-month treatment arm and Not randomized participants; and up to 36 months after study treatment start for Nilotinib 36-month treatment arm. |
| BCR-ABL Ratio (Expressed as a Percentage) During the TFR Phase | BCR-ABL/control gene (ABL) transcript ratio by international scale (IS) (expressed as a percentage) during the TFR phase. BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes. Participants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotinib 24-month treatment arm had a maximum of 36 months of TFR phase. | From Month 1 after entering TFR phase up to 24 months after entering TFR phase for Nilotinib 36-month treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-month treatment arm |
| BCR-ABL Ratio (Expressed as a Percentage) During the Nilotinib Re-treatment Phase | BCR-ABL/control gene (ABL) transcript ratio by international scale (IS) (expressed as a percentage) during the nilotinib re-treatment phase. BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes. | From Day 1 after entering the re-treatment phase up to 24 months after entering re-treatment phase for Nilotinib 36-month treatment arm and 36 months after entering the re-treatment phase for Nilotinib 24-month treatment arm |
| Progression-free Survival (PFS) During the TFR Phase of the Study. | PFS is defined as the time from the date of start of the nilotinib TFR phase to the date of acelerated phase/blast crisis (AP/BC) or death, whichever came first. Participants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotini 24-month treatment arm had a maximum of 36 months of TFR phase. Patients not known to have recurred or died on or before the cut-off date for PFS analysis were censored at the date of their last assessment (cytogenetic, hematology or extramedullary) for patients who were on study, and at the date of last contact for patients who were in follow-up. | From the start of the TFR phase to progression to AP/BC or death up to 24 months after entering TFR phase for Nilotininb 36-month treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-month treatment arm |
| Treatment -Free Survival (TFS) During the TFR Phase of the Study | TFS is defined as the time from the start of the TFR phase to the date of the earliest of the following: loss of MMR, confirmed loss of MR4.0,re-start of nilotinib treatment, progression to AP/BC, or death from any cause. Patients not known to have had any of the events on or before the cut-off date were censored at the earlier of the date of their last assessment for patients who were still on study and the date of last contact for patients who were in follow-up. Participants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotinib 24-month treatment arm had a maximum of 36 months of TFR phase. MMR is defined as ≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1%BCR-ABL. MR4.0 is defined as either detectable disease ≤0.01%BCR-ABL IS or undetectable disease in cDNA with ≥10,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL) | From the start of the TFR phase to the date of occurrence of treatment-free survival event, up to 24 months after entering TFR phase for Nilotinib 36-month treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-month treatment arm |
| Overall Survival (OS) Rate During the TFR Phase of the Study. | OS is defined as the time from start of the TFR phase to the time of death due to any cause. Participants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotini 24-month treatment arm had a maximum of 36 months of TFR phase. For participants without any event on or before the cut-off date, survival time will be censored at the date of their last assessment for patients who are still on study, and at the date of last contact for patients who are in follow-up. | From the start of the TFR phase to death due to any cause, assessed up to 24 months after entering TFR phase for Nilotinib 36-month treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-month treatment arm |
| Graz |
| 8036 |
| Austria |
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| Novartis Investigative Site | Vicenza | VI | 36100 | Italy |
| Novartis Investigative Site | Verona | VR | 37126 | Italy |
| Novartis Investigative Site | Naples | 80131 | Italy |
| Novartis Investigative Site | Novara | 28100 | Italy |
| Novartis Investigative Site | Perugia | 06129 | Italy |
| Novartis Investigative Site | Bergen | NO-5021 | Norway |
| Novartis Investigative Site | Oslo | NO-0310 | Norway |
| Novartis Investigative Site | Chorzów | 41-500 | Poland |
| Novartis Investigative Site | Gdansk | 80 952 | Poland |
| Novartis Investigative Site | Katowice | 40-027 | Poland |
| Novartis Investigative Site | Krakow | 30-510 | Poland |
| Novartis Investigative Site | Olsztyn | 10 561 | Poland |
| Novartis Investigative Site | Opole | 45-372 | Poland |
| Novartis Investigative Site | Torun | 87 100 | Poland |
| Novartis Investigative Site | Warsaw | 02 106 | Poland |
| Novartis Investigative Site | Warsaw | 02 776 | Poland |
| Novartis Investigative Site | Lisbon | 1099 023 | Portugal |
| Novartis Investigative Site | Lisbon | 1749-035 | Portugal |
| Novartis Investigative Site | Porto | 4099-001 | Portugal |
| Novartis Investigative Site | Porto | 4200 319 | Portugal |
| Novartis Investigative Site | Porto | 4200-072 | Portugal |
| Novartis Investigative Site | Bucharest | District 2 | 022328 | Romania |
| Novartis Investigative Site | Bucharest | 030 171 | Romania |
| Novartis Investigative Site | Bucharest | 500098 | Romania |
| Novartis Investigative Site | Cluj-Napoca | 400124 | Romania |
| Novartis Investigative Site | Iași | 700483 | Romania |
| Novartis Investigative Site | Sibiu | 550245 | Romania |
| Novartis Investigative Site | Timișoara | 300 079 | Romania |
| Novartis Investigative Site | Belgrade | 11000 | Serbia |
| Novartis Investigative Site | Belgrade | 11070 | Serbia |
| Novartis Investigative Site | Niš | 18000 | Serbia |
| Novartis Investigative Site | Novi Sad | Serbia |
| Novartis Investigative Site | Bratislava | 85107 | Slovakia |
| Novartis Investigative Site | Martin | 03601 | Slovakia |
| Novartis Investigative Site | Ljubljana | 1000 | Slovenia |
| Novartis Investigative Site | Granada | Andalusia | 18014 | Spain |
| Novartis Investigative Site | Jaén | Andalusia | 23007 | Spain |
| Novartis Investigative Site | Málaga | Andalusia | 29010 | Spain |
| Novartis Investigative Site | Seville | Andalusia | 41009 | Spain |
| Novartis Investigative Site | Seville | Andalusia | 41013 | Spain |
| Novartis Investigative Site | Palma de Mallorca | Balearic Islands | 07120 | Spain |
| Novartis Investigative Site | Sabadell | Barcelona | 08208 | Spain |
| Novartis Investigative Site | Donostia / San Sebastian | Basque Country | 20080 | Spain |
| Novartis Investigative Site | León | Castille and León | 24071 | Spain |
| Novartis Investigative Site | Salamanca | Castille and León | 37007 | Spain |
| Novartis Investigative Site | Valladolid | Castille and León | 47011 | Spain |
| Novartis Investigative Site | Badalona | Catalonia | 08916 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08003 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08036 | Spain |
| Novartis Investigative Site | Girona | Catalonia | 17007 | Spain |
| Novartis Investigative Site | L'Hospitalet de Llobregat | Catalonia | 08907 | Spain |
| Novartis Investigative Site | Tarragona | Catalonia | 43005 | Spain |
| Novartis Investigative Site | Cáceres | Extremadura | 10003 | Spain |
| Novartis Investigative Site | A Coruña | Galicia | 15006 | Spain |
| Novartis Investigative Site | Pontevedra | Galicia | 36071 | Spain |
| Novartis Investigative Site | Santiago de Compostela | Galicia | 15706 | Spain |
| Novartis Investigative Site | Pamplona | Navarre | 31008 | Spain |
| Novartis Investigative Site | Alicante | Valencia | 03010 | Spain |
| Novartis Investigative Site | Alzira | Valencia | 46600 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46026 | Spain |
| Novartis Investigative Site | Granollers | 08402 | Spain |
| Novartis Investigative Site | Madrid | 28006 | Spain |
| Novartis Investigative Site | Madrid | 28009 | Spain |
| Novartis Investigative Site | Madrid | 28031 | Spain |
| Novartis Investigative Site | Madrid | 28034 | Spain |
| Novartis Investigative Site | Madrid | 28040 | Spain |
| Novartis Investigative Site | Madrid | 28041 | Spain |
| Novartis Investigative Site | Madrid | 28046 | Spain |
| Novartis Investigative Site | Madrid | 28222 | Spain |
| Novartis Investigative Site | Murcia | 30008 | Spain |
| Novartis Investigative Site | Santa Cruz de Tenerife | 38009 | Spain |
| Novartis Investigative Site | Zaragoza | 50009 | Spain |
| Novartis Investigative Site | Stockholm | SE-171 76 | Sweden |
| Novartis Investigative Site | East Yorkshire | HU16 5JQ | United Kingdom |
| Novartis Investigative Site | Edinburgh | EH4 2XU | United Kingdom |
| Novartis Investigative Site | London | EC1A 7BE | United Kingdom |
| Novartis Investigative Site | London | W12 0HS | United Kingdom |
Participants were treated with nilotinib 300mg BID for 36 months and, thereafter, entered the 24-month TFR phase
| FG002 | Not Randomized | Participants were treated with nilotinib 300mg BID for 24 months, but did not achieve a sustained molecular response after 24 months of treatment and were not randomized. |
| Participants Who Signed Informed Consent | Participants for whom informed consent was obtained prior to any study specific procedure |
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| COMPLETED |
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| NOT COMPLETED |
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| TFR Phase |
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| Re-treatment Phase |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nilotinib 24-month Treatment | Participants were treated with nilotinib 300mg BID for 24 months and, thereafter, entered the 36-month TFR phase |
| BG001 | Nilotinib 36-month Treatment | Participants were treated with nilotinib 300mg BID for 36 months and, thereafter, entered the 24-month TFR phase |
| BG002 | Not Randomized | Participants were treated with nilotinib 300mg BID for 24 months, but did not achieve a sustained molecular response after 24 months of treatment and were not randomized. |
| BG003 | 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, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Remained in Treatment Free Remission (TFR) Without Molecular Relapse 12 Months After Entering the TFR Phase | Number of participants who remained in TFR (≥molecular response (MR) 4.0) without molecular relapse 12 months after entering the TFR phase (without re-starting nilotinib therapy) divided by the number of participants who entered the TFR phase and multiplied by 100. Molecular relapse during TFR is defined as the loss of major molecular response (MMR), or the confirmed loss of MR4.0 (defined by 3 consecutive tests less than MR4.0 assessed at 3 consecutive visits during TFR phase). Participants dropping out early from the study during the TFR phase were considered as unsuccessful TFR. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MMR is defined as≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1% BCR-ABL. MR4.0 is defined as either detectable disease≤0.01% BCR-ABL or undetectable disease in cDNA with≥10,000 ABL transcripts | All enrolled subjects who entered the TFR phase | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 months after entering the TFR phase, which is after 36 months from study treatment start for Nilotinib 24-month treatment arm and after 48 months from study treatment start for Nilotinib 36-month treatment arm |
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| Secondary | Cumulative Incidence of MMR During the Pre-randomization Induction/Consolidation Phase Among Participants Without That Response at Study Entry | Number of participants who were in MMR during pre-randomization induction/consolidation phase divided by the number of participants without that response at baseline and multiplied by 100. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MMR is defined as ≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1% BCR-ABL. | All enrolled subjects for whom written informed consent was obtained prior to any study specific procedure who did not reach MMR at baseline | Posted | Number | 95% Confidence Interval | Percentage of participants | From baseline up to 24 months after study treatment start |
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| Secondary | Cumulative Incidence of MMR During the Post-randomization Consolidation Phase Among Participants Without That Response at Study Entry | Number of participants who were in MMR during post-randomization consolidation phase divided by the number of participants without that response at baseline and multiplied by 100. Post-randomization consolidation phase corresponded to the 12-month additional treatment (after randomization) for Nilotinib 36-month treatment arm. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MMR is defined as ≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1% BCR-ABL. | All enrolled subjects for whom written informed consent was obtained prior to any study specific procedure who did not reach MMR at baseline. Only participants randomized to Nilotinib 36-month treatment arm entered the post-randomization consolidation phase. | Posted | Number | 95% Confidence Interval | Percentage of participants | From randomization (month 24 after study treatment start) up to 36 months after study treatment start |
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| Secondary | Cumulative Incidence of MR4.0 During the Pre-randomization Induction/Consolidation Phase Among Participants Without That Response at Study Entry | Number of participants who were in MR4.0 during the pre-randomization induction/consolidation phase divided by the number of participants without that response at baseline and multiplied by 100. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.0 is defined as either detectable disease ≤0.01% BCR-ABL IS or undetectable disease in cDNA with ≥10,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL) | All enrolled subjects for whom written informed consent was obtained prior to any study specific procedure who did not reach MR4.0 at baseline | Posted | Number | 95% Confidence Interval | Percentage of participants | From baseline up to 24 months after study treatment start |
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| Secondary | Cumulative Incidence of MR4.0 During the Post-randomization Consolidation Phase Among Participants Without That Response at Study Entry | Number of participants who were in MR4.0 during the post-randomization consolidation phase divided by the number of participants without that response at baseline and multiplied by 100. Post-randomization consolidation phase corresponded to the 12-month additional treatment (after randomization) for Nilotinib 36-month treatment arm. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.0 is defined as either detectable disease ≤0.01% BCR-ABL IS or undetectable disease in cDNA with ≥10,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL) | All enrolled subjects for whom written informed consent was obtained prior to any study specific procedure who did not reach MR4.0 at baseline. Only participants randomized to Nilotinib 36-month treatment arm entered the post-randomization consolidation phase | Posted | Number | 95% Confidence Interval | Percentage of participants | From randomization (month 24 after study treatment start) up to 36 months after study treatment start |
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| Secondary | Cumulative Incidence of MR4.5 During the Pre-randomization Induction/Consolidation Phase Among Participants Without That Response at Study Entry | Number of participants who were in MR4.5 during the pre-randomization induction/consolidation phase divided by the number of participants without that response at baseline and multiplied by 100. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.5 is defined as either detectable disease ≤ 0.0032% BCR-ABL IS; or undetectable disease within cDNA with ≥ 32,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL) | All enrolled subjects for whom written informed consent was obtained prior to any study specific procedure who did not reach MR4.5 at baseline | Posted | Number | 95% Confidence Interval | Percentage of participants | From baseline up to 24 months after study treatment start |
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| Secondary | Cumulative Incidence of MR4.5 During the Post-randomization Consolidation Phase Among Participants Without That Response at Study Entry | Number of participants who were in MR4.5 during the post-randomization consolidation phase divided by the number of participants without that response at baseline and multiplied by 100. Post-randomization consolidation phase corresponded to the 12-month additional treatment (after randomization) for Nilotinib 36-month treatment arm. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.5 is defined as either detectable disease ≤ 0.0032% BCR-ABL IS; or undetectable disease within cDNA with ≥ 32,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL) | All enrolled subjects for whom written informed consent was obtained prior to any study specific procedure who did not reach MR4.5 at baseline. Only participants randomized to Nilotinib 36-month treatment arm entered the post-randomization consolidation phase | Posted | Number | 95% Confidence Interval | Percentage of participants | From randomization (month 24 after study treatment start) up to 36 months after study treatment start |
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| Secondary | Cumulative Incidence of MMR During the Pre-randomization Induction/Consolidation Phase | Number of participants who were in MMR during the pre-randomization induction/consolidation phase divided by the number of enrolled participants and multiplied by 100. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MMR is defined as ≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1% BCR-ABL. | All enrolled subjects for whom written informed consent was obtained prior to any study specific procedure | Posted | Number | 95% Confidence Interval | Percentage of participants | From baseline up to 24 months after study treatment start |
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| Secondary | Cumulative Incidence of MMR During the Post-randomization Consolidation Phase | Number of participants who were in MMR during the post-randomization consolidation phase divided by the number of enrolled participants and multiplied by 100. Post-randomization consolidation phase corresponded to the 12-month additional treatment (after randomization) for Nilotinib 36-month treatment arm. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MMR is defined as ≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1% BCR-ABL. | All enrolled subjects for whom written informed consent was obtained prior to any study specific procedure. Only participants randomized to Nilotinib 36-month treatment arm entered the post-randomization consolidation phase | Posted | Number | 95% Confidence Interval | Percentage of participants | From randomization (month 24 after study treatment start) up to 36 months after study treatment start |
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| Secondary | Cumulative Incidence of MR4.0 During the Pre-randomization Induction/Consolidation Phase | Number of participants who were in MR4.0 during the pre-randomization induction/consolidation phase divided by the number of enrolled participants and multiplied by 100. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.0 is defined as either detectable disease ≤0.01% BCR-ABL IS or undetectable disease in cDNA with ≥10,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL) | All enrolled subjects for whom written informed consent was obtained prior to any study specific procedure | Posted | Number | 95% Confidence Interval | Percentage of participants | From baseline up to 24 months after study treatment start |
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| Secondary | Cumulative Incidence of MR4.0 During the Post-randomization Consolidation Phase | Number of participants who were in MR4.0 during the post-randomization consolidation phase divided by the number of enrolled participants and multiplied by 100. Post-randomization consolidation phase corresponded to the 12-month additional treatment (after randomization) for Nilotinib 36-month treatment arm. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.0 is defined as either detectable disease ≤0.01% BCR-ABL IS or undetectable disease in cDNA with ≥10,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL) | All enrolled subjects for whom written informed consent was obtained prior to any study specific procedure. Only participants randomized to Nilotinib 36-month treatment arm entered the post-randomization consolidation phase. | Posted | Number | 95% Confidence Interval | Percentage of participants | From randomization (month 24 after study treatment start) up to 36 months after study treatment start |
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| Secondary | Cumulative Incidence of MR4.5 During the Pre-randomization Induction/Consolidation Phase | Number of participants who were in MR4.5 during the pre-randomization induction/consolidation phase divided by the number of enrolled participants and multiplied by 100. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.5 is defined as either detectable disease ≤ 0.0032% BCR-ABL IS; or undetectable disease within cDNA with ≥ 32,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL) | All enrolled subjects for whom written informed consent was obtained before any study specific procedure | Posted | Number | 95% Confidence Interval | Percentage of participants | From baseline up to 24 months after study treatment start |
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| Secondary | Cumulative Incidence of MR4.5 During the Post-randomization Consolidation Phase | Number of participants who were in MR4.5 during the post-randomization consolidation phase divided by the number of enrolled participants and multiplied by 100. Post-randomization consolidation phase corresponded to the 12-month additional treatment (after randomization) for Nilotinib 36-month treatment arm. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.5 is defined as either detectable disease ≤ 0.0032% BCR-ABL IS; or undetectable disease within cDNA with ≥ 32,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL) | All enrolled subjects for whom written informed consent was obtained before any study specific procedure. Only participants randomized to Nilotinib 36-month treatment arm entered the post-randomization consolidation phase. | Posted | Number | 95% Confidence Interval | Percentage of participants | From randomization (month 24 after study treatment start) up to 36 months after study treatment start |
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| Secondary | Percentage of Participants Who Were in MMR During TFR Phase | Number of participants who were in MMR at selected timepoints divided by the number of participants in the TFR phase and multiplied by 100. Participants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotinib 24-month treatment arm had a maximum of 36 months of TFR phase. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MMR is defined as ≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1% BCR-ABL. | All enrolled subjects who entered the TFR phase | Posted | Number | 95% Confidence Interval | Percentage of participants | From Month 1 after entering TFR phase up to 24 months after entering TFR phase for Nilotinib 36-month treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-month treatment arm |
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| Secondary | Percentage of Participants Who Were in MR4.0 During the TFR Phase | Number of participants who were in MR4.0 at selected timepoints divided by the number of participants in the TFR phase and multiplied by 100. Participants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotinib 24-month treatment arm had a maximum of 36 months of TFR phase. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.0 is defined as either detectable disease ≤0.01% BCR-ABL IS or undetectable disease in cDNA with ≥10,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL) | All enrolled subjects who entered the TFR phase | Posted | Number | 95% Confidence Interval | Percentage of participants | From Month 1 after entering TFR phase up to 24 months after entering TFR phase for Nilotininb 36-months treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-months treatment arm |
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| Secondary | Percentage of Participants Who Were in MR4.5 During the TFR Phase | Number of participants who were in MR4.5 at selected timepoints divided by the number of participants in the TFR phase and multiplied by 100. Participants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotinib 24-month treatment arm had a maximum of 36 months of TFR phase. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.5 is defined as either detectable disease ≤ 0.0032% BCR-ABL IS; or undetectable disease within cDNA with ≥ 32,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL) | All enrolled subjects who entered the TFR phase | Posted | Number | 95% Confidence Interval | Percentage of participants | From Month 1 after entering TFR phase up to 24 months after entering TFR phase for Nilotininb 36-month treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-month treatment arm |
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| Secondary | BCR-ABL Ratio (Expressed as a Percentage) During the Induction/Consolidation Phase | BCR-ABL transcript ratio by international scale (IS) (expressed as a percentage) during the induction/consolidation phase. Participants randomized to Nilotinib 36-month treatment arm had 12-month additional consolidation phase (post-randomization). | All enrolled subjects for whom written informed consent was obtained prior to any study specific procedure. Number analyzed signified number of participants with available data for this outcome measure at specified timepoints. | Posted | Mean | Standard Deviation | Percentage | From baseline up to 24 months after study treatment start for Nilotinib 24-month treatment arm and Not randomized participants; and up to 36 months after study treatment start for Nilotinib 36-month treatment arm. |
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| Secondary | BCR-ABL Ratio (Expressed as a Percentage) During the TFR Phase | BCR-ABL/control gene (ABL) transcript ratio by international scale (IS) (expressed as a percentage) during the TFR phase. BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes. Participants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotinib 24-month treatment arm had a maximum of 36 months of TFR phase. | All enrolled subjects who entered the TFR phase. Number analyzed signified number of participants with available data for this outcome measure at specified timepoints. | Posted | Mean | Standard Deviation | Percentage | From Month 1 after entering TFR phase up to 24 months after entering TFR phase for Nilotinib 36-month treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-month treatment arm |
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| Secondary | BCR-ABL Ratio (Expressed as a Percentage) During the Nilotinib Re-treatment Phase | BCR-ABL/control gene (ABL) transcript ratio by international scale (IS) (expressed as a percentage) during the nilotinib re-treatment phase. BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes. | All enrolled subjects who entered the re-treatment phase. Number analyzed signified number of participants with available data for this outcome measure at specified timepoints. | Posted | Mean | Standard Deviation | Percentage | From Day 1 after entering the re-treatment phase up to 24 months after entering re-treatment phase for Nilotinib 36-month treatment arm and 36 months after entering the re-treatment phase for Nilotinib 24-month treatment arm |
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| Secondary | Progression-free Survival (PFS) During the TFR Phase of the Study. | PFS is defined as the time from the date of start of the nilotinib TFR phase to the date of acelerated phase/blast crisis (AP/BC) or death, whichever came first. Participants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotini 24-month treatment arm had a maximum of 36 months of TFR phase. Patients not known to have recurred or died on or before the cut-off date for PFS analysis were censored at the date of their last assessment (cytogenetic, hematology or extramedullary) for patients who were on study, and at the date of last contact for patients who were in follow-up. | All enrolled subjects who entered the TFR phase | Posted | Median | 95% Confidence Interval | Months | From the start of the TFR phase to progression to AP/BC or death up to 24 months after entering TFR phase for Nilotininb 36-month treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-month treatment arm |
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| Secondary | Treatment -Free Survival (TFS) During the TFR Phase of the Study | TFS is defined as the time from the start of the TFR phase to the date of the earliest of the following: loss of MMR, confirmed loss of MR4.0,re-start of nilotinib treatment, progression to AP/BC, or death from any cause. Patients not known to have had any of the events on or before the cut-off date were censored at the earlier of the date of their last assessment for patients who were still on study and the date of last contact for patients who were in follow-up. Participants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotinib 24-month treatment arm had a maximum of 36 months of TFR phase. MMR is defined as ≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1%BCR-ABL. MR4.0 is defined as either detectable disease ≤0.01%BCR-ABL IS or undetectable disease in cDNA with ≥10,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL) | All enrolled subjects who entered the TFR phase | Posted | Median | 95% Confidence Interval | Months | From the start of the TFR phase to the date of occurrence of treatment-free survival event, up to 24 months after entering TFR phase for Nilotinib 36-month treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-month treatment arm |
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| Secondary | Overall Survival (OS) Rate During the TFR Phase of the Study. | OS is defined as the time from start of the TFR phase to the time of death due to any cause. Participants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotini 24-month treatment arm had a maximum of 36 months of TFR phase. For participants without any event on or before the cut-off date, survival time will be censored at the date of their last assessment for patients who are still on study, and at the date of last contact for patients who are in follow-up. | All enrolled subjects | Posted | Median | 95% Confidence Interval | Months | From the start of the TFR phase to death due to any cause, assessed up to 24 months after entering TFR phase for Nilotinib 36-month treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-month treatment arm |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | All Collected Deaths | Deaths on-treatment were collected during the induction/consolidation phase (from the first dose of study drug to 30 days after study treatment discontinuation, assessed up to 24 months for Nilotinib 24-month treatment arm and Not randomized, and up to 36 months for Nilotinib 36-month treatment arm) and during the re-treatment phase (from the start date of the re-treatment phase to 30 days after study treatment discontinuation, assessed up to 36 months for Nilotinib 24-month treatment arm and up to 24 months for Nilotinib 36-month treatment arm). Total deaths were collected from first dose of study drug until end of study, up to maximum duration of 5 years | All enrolled participants for whom informed consent was obtained prior to any study specific procedure were included. | Posted | Count of Participants | Participants | On-treatment deaths: induction/consolidation phase (up to 24 months or 36 months from treatment start, depending on arm) and re-treatment phase (up to 36 months or up to 24 months from re-treatment start, depending on arm). All deaths: up to 5 years |
|
Any sign or symptom that occurred during the induction/consolidation phase and re-treatment phase. For this analysis, all enrolled participants for whom informed consent was obtained prior to any study specific procedure were included.
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 | Nilotinib 24-month Treatment | Participants were treated with nilotinib 300mg BID for 24 months and, thereafter, entered the 36-month TFR phase | 1 | 120 | 33 | 120 | 97 | 120 |
| EG001 | Nilotinib 36-month Treatment | Participants were treated with nilotinib 300mg BID for 36 months and, thereafter, entered the 24-month TFR phase | 1 | 118 | 27 | 118 | 104 | 118 |
| EG002 | Not Randomized | Participants were treated with nilotinib 300mg BID for 24 months, but did not achieve a sustained molecular response after 24 months of treatment and were not randomized. | 3 | 381 | 76 | 381 | 280 | 381 |
| EG003 | Total | Total | 5 | 619 | 136 | 619 | 481 | 619 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Lymphadenopathy mediastinal | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Arrhythmia supraventricular | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hypertensive cardiomyopathy | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Lumbar hernia | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hyperplasia | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Necrosis | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Bacterial pyelonephritis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Gallbladder empyema | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Neuroborreliosis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Pneumonia legionella | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Vestibular neuronitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Eye contusion | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Metatarsalgia | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Spondylitis | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Systematic Assessment |
| |
| Glioblastoma | 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 |
| |
| Myelofibrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Systematic Assessment |
| |
| Cerebral artery thrombosis | 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 |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Mononeuropathy | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (23.1) | Systematic Assessment |
| |
| Adjustment disorder | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Acquired hydrocele | Reproductive system and breast disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Adnexa uteri mass | Reproductive system and breast disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Arterial disorder | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Arterial occlusive disease | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Ischaemia | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Thromboangiitis obliterans | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hypertriglyceridaemia | 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 |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Dry skin | 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 |
| |
| Hypertension | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 16, 2021 | Jun 23, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C498826 | nilotinib |
Not provided
Not provided
Not provided
| Lost to Follow-up |
|
| Physician Decision |
|
| Logistical problems |
|
| Protocol deviation |
|
| Withdrawal by Subject |
|
| Administrative problems |
|
| Withdrawal by Subject |
|
| Unstable MR |
|
| Physician Decision |
|
| Lost to Follow-up |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Black |
|
| Asian |
|
| Native American |
|
| North African descent |
|
| Unknown |
|
| Other |
|
|
|
|
Participants were treated with nilotinib 300mg BID for 24 months, but did not achieve a sustained molecular response after 24 months of treatment and were not randomized.
|
|
|
|
Participants were treated with nilotinib 300mg BID for 24 months, but did not achieve a sustained molecular response after 24 months of treatment and were not randomized.
|
|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Nilotinib 36-month Treatment Arm |
Participants were treated with nilotinib 300mg BID for 36 months and, thereafter, entered the 24-month TFR phase |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| OG002 | Not Randomized | Participants were treated with nilotinib 300mg BID for 24 months, but did not achieve a sustained molecular response after 24 months of treatment and were not randomized. |
|
|