Trial Outcomes & Findings for A Study of Midostaurin Efficacy and Safety in Newly Diagnosed Patients With FLT3-mutated AML (NCT NCT03280030)

Last Updated: 2025-03-20

Results Overview

Percentage of Safety Events, defined as death or serious adverse event leading to treatment discontinuation that occurs on or before Day 21 of the first Consolidation cycle. This was determined by the Independent Safety Committee (ISC) to be definitely or probably related to midostaurin. Percentage was calculated based on the percentage of subjects with safety event out of 3 evaluable subjects in Part 1.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

67 participants

Primary outcome timeframe

up to Day 21 of the first Consolidation cycle; cycle = 28 days

Results posted on

2025-03-20

Participant Flow

Part 1 of the study enrolled 5 Japan adult subjects with newly diagnosed (ND) FLT3-mutated or non-mutated AML. Part 2 randomized 62 adult subjects with ND FLT3-mutated AML. The efficacy analysis was on the 62 randomized subjects in Part 2. The safety analysis was considered separately on 5 subjects in Part 1 \& 61 out of 62 randomized subjects in Part 2, as 1 subject did not receive randomized treatment (placebo). The PK analysis was on subjects treated with midostaurin in Part 1 or Part 2.

Subjects were enrolled in 6 countries and at 34 study centers. In Part 1, subjects started chemotherapy at day 1 and midostaurin at day 8. In Part 2, subjects started chemotherapy at day 1 and were randomized to midostaurin or placebo at day 8.

Participant milestones

Participant milestones
Measure	Midostaurin: Part 1 (Japan Only) Part 1 was conducted to evaluate the safety and tolerability of midostaurin in combination with daunorubicin/cytarabine induction and high-dose cytarabine consolidation in Japanese patients. The safety evaluation period began on Day 1 of the first induction cycle (Cycle 1 Day 1) and continued until Day 21 of the first consolidation cycle.	Midostaurin: Part 2 Patients took study drug on day 8-21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase.	Placebo: Part 2 Patients took Placebo on day 8 - 21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase.
Part 1 - Safety Evaluation STARTED	5	0	0
Part 1 - Safety Evaluation COMPLETED	0	0	0
Part 1 - Safety Evaluation NOT COMPLETED	5	0	0
Part 2 - Efficacy STARTED	0	30	32
Part 2 - Efficacy Randomized, Not Treated	0	0	1
Part 2 - Efficacy COMPLETED	0	4	4
Part 2 - Efficacy NOT COMPLETED	0	26	28

Reasons for withdrawal

Reasons for withdrawal
Measure	Midostaurin: Part 1 (Japan Only) Part 1 was conducted to evaluate the safety and tolerability of midostaurin in combination with daunorubicin/cytarabine induction and high-dose cytarabine consolidation in Japanese patients. The safety evaluation period began on Day 1 of the first induction cycle (Cycle 1 Day 1) and continued until Day 21 of the first consolidation cycle.	Midostaurin: Part 2 Patients took study drug on day 8-21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase.	Placebo: Part 2 Patients took Placebo on day 8 - 21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase.
Part 1 - Safety Evaluation Physician Decision	2	0	0
Part 1 - Safety Evaluation Disease progression	1	0	0
Part 1 - Safety Evaluation Adverse Event	2	0	0
Part 2 - Efficacy Adverse Event	0	4	6
Part 2 - Efficacy Death	0	3	0
Part 2 - Efficacy Physician Decision	0	10	16
Part 2 - Efficacy Withdrawal by Subject	0	2	1
Part 2 - Efficacy Progressive disease	0	7	5

Baseline Characteristics

A Study of Midostaurin Efficacy and Safety in Newly Diagnosed Patients With FLT3-mutated AML

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Midostaurin: Part 1 (Japan Only) n=5 Participants Part 1 was conducted to evaluate the safety and tolerability of midostaurin in combination with daunorubicin/cytarabine induction and high-dose cytarabine consolidation in Japanese patients. The safety evaluation period began on Day 1 of the first induction cycle (Cycle 1 Day 1) and continued until Day 21 of the first consolidation cycle.	Midostaurin: Part 2 n=30 Participants Patients took study drug on day 8-21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase.	Placebo: Part 2 n=32 Participants Patients took Placebo on day 8 - 21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase.	Total n=67 Participants Total of all reporting groups
Age, Customized <60 years	3 Participants n=5 Participants	27 Participants n=7 Participants	23 Participants n=5 Participants	53 Participants n=4 Participants
Age, Customized 60 - <65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants
Age, Customized ≥65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	16 Participants n=7 Participants	17 Participants n=5 Participants	35 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	14 Participants n=7 Participants	15 Participants n=5 Participants	32 Participants n=4 Participants
Race/Ethnicity, Customized Japanese	5 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	29 Participants n=4 Participants
Race/Ethnicity, Customized Korean	0 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants
Race/Ethnicity, Customized Chinese	0 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants	13 Participants n=4 Participants
Race/Ethnicity, Customized Vietnamese	0 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Missing	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized White	0 Participants n=5 Participants	9 Participants n=7 Participants	0 Participants n=5 Participants	9 Participants n=4 Participants

PRIMARY outcome

Timeframe: up to Day 21 of the first Consolidation cycle; cycle = 28 days

Population: Patients enrolled in Part 1: 3 patients out of 5 patients in Part 1 were evaluable for safety evaluation as determined by Independent Safety Committee (ISC).

Outcome measures

Outcome measures
Measure	Midostaurin: Part 1 (Japan Only) n=5 Participants Part 1 was conducted to evaluate the safety and tolerability of midostaurin in combination with daunorubicin/cytarabine induction and high-dose cytarabine consolidation in Japanese patients. The safety evaluation period began on Day 1 of the first induction cycle (Cycle 1 Day 1) and continued until Day 21 of the first consolidation cycle.	Midostaurin: Part 2 Patients took study drug on day 8-21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase	Placebo: Part 2 Patients took Placebo on day 8 - 21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase.	Other Participants These participants were not randomized to any treatment but received chemotherapy and died during the study. This group also includes 1 participant who was randomized to placebo but did not receive placebo and died during the on-treatment period.
Percentage of Safety Events (Part 1, Japan Only) Experienced at least 1 adverse event (AE)	5 Participants	—	—	—
Percentage of Safety Events (Part 1, Japan Only) Safety events determined by ISC related to midostaurin (n = 3, 0, 0)	0 Participants	—	—	—

PRIMARY outcome

Timeframe: up to 3 years after last patient started treatment

Population: Full Analysis Set (FAS): The FAS comprised of all subjects to whom study drug (midostaurin/placebo) had been assigned by randomization. Therefore, all Japanese subjects treated during Part 1 were not eligible for the FAS.

Event Free survival is defined as the time from the date of randomization until an EFS event is observed. An EFS event is defined as a failure to obtain a complete remission (CR) within an induction 2, relapse after CR, or death due to any cause, whichever occurs first. The objective was to evaluate the efficacy based on EFS of midostaurin versus placebo in combination with daunorubicin/cytarabine induction, with high-dose cytarabine consolidation, and with midostaurin single agent continuation therapy in newly diagnosed patients with FLT3-mutated AML.

Outcome measures

Outcome measures
Measure	Midostaurin: Part 1 (Japan Only) n=30 Participants Part 1 was conducted to evaluate the safety and tolerability of midostaurin in combination with daunorubicin/cytarabine induction and high-dose cytarabine consolidation in Japanese patients. The safety evaluation period began on Day 1 of the first induction cycle (Cycle 1 Day 1) and continued until Day 21 of the first consolidation cycle.	Midostaurin: Part 2 n=32 Participants Patients took study drug on day 8-21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase	Placebo: Part 2 Patients took Placebo on day 8 - 21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase.	Other Participants These participants were not randomized to any treatment but received chemotherapy and died during the study. This group also includes 1 participant who was randomized to placebo but did not receive placebo and died during the on-treatment period.
Event Free Survival (EFS) (Part 2 - Randomized, Controlled)	7.6 Months Interval 3.6 to NA: The final data was not mature to estimate the upper limit of the confidence interval for median EFS.	NA Months Interval 8.2 to NA: The Final data was not mature to estimate the median EFS (i.e., not reached) and its upper limit of the confidence interval.	—	—

SECONDARY outcome

Timeframe: up to 3 years after last patient started treatment

Population: FAS: The FAS comprised of all subjects to whom study drug (midostaurin/placebo) had been assigned by randomization. Therefore, all Japanese subjects treated during Part 1 were not eligible for the FAS.

Overall survival defined as the time from the date of randomization to date of death due to any cause

Outcome measures

Outcome measures
Measure	Midostaurin: Part 1 (Japan Only) n=30 Participants Part 1 was conducted to evaluate the safety and tolerability of midostaurin in combination with daunorubicin/cytarabine induction and high-dose cytarabine consolidation in Japanese patients. The safety evaluation period began on Day 1 of the first induction cycle (Cycle 1 Day 1) and continued until Day 21 of the first consolidation cycle.	Midostaurin: Part 2 n=32 Participants Patients took study drug on day 8-21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase	Placebo: Part 2 Patients took Placebo on day 8 - 21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase.	Other Participants These participants were not randomized to any treatment but received chemotherapy and died during the study. This group also includes 1 participant who was randomized to placebo but did not receive placebo and died during the on-treatment period.
Overall Survival	NA Months Interval 16.8 to NA: The final data was not mature to estimate the median OS (i.e., not reached) and its upper limit of the confidence interval.	NA Months Interval 18.8 to NA: The final data was not mature to estimate the median OS (i.e., not reached) and its upper limit of the confidence interval.	—	—

SECONDARY outcome

Timeframe: up to 3 years after last patient started treatment

Complete Remission is defined as the percentage of participants with a CR according to Chelson Criteria, at various timepoints

Outcome measures

Outcome measures
Measure	Midostaurin: Part 1 (Japan Only) n=30 Participants Part 1 was conducted to evaluate the safety and tolerability of midostaurin in combination with daunorubicin/cytarabine induction and high-dose cytarabine consolidation in Japanese patients. The safety evaluation period began on Day 1 of the first induction cycle (Cycle 1 Day 1) and continued until Day 21 of the first consolidation cycle.	Midostaurin: Part 2 n=32 Participants Patients took study drug on day 8-21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase	Placebo: Part 2 Patients took Placebo on day 8 - 21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase.	Other Participants These participants were not randomized to any treatment but received chemotherapy and died during the study. This group also includes 1 participant who was randomized to placebo but did not receive placebo and died during the on-treatment period.
Percentage of Participants With Complete Remission (CR) End of Induction cycle 2 (C2) CR	13.3 Percentage of participants Interval 3.76 to 30.72	9.4 Percentage of participants Interval 1.98 to 25.02	—	—
Percentage of Participants With Complete Remission (CR) End of Induction C1: Morphologic CRp	3.3 Percentage of participants Interval 0.08 to 17.22	0.0 Percentage of participants Interval 0.0 to 10.89	—	—
Percentage of Participants With Complete Remission (CR) Overall CR	70.0 Percentage of participants Interval 50.6 to 85.27	78.1 Percentage of participants Interval 60.03 to 90.72	—	—
Percentage of Participants With Complete Remission (CR) Morphologic CR with incomplete platelet count recovery (CRp)	6.7 Percentage of participants Interval 0.86 to 22.07	0.0 Percentage of participants Interval 0.0 to 10.89	—	—
Percentage of Participants With Complete Remission (CR) End of Induction cycle 1 (C1) CR	56.7 Percentage of participants Interval 37.43 to 74.54	65.6 Percentage of participants Interval 46.81 to 81.43	—	—
Percentage of Participants With Complete Remission (CR) End of Induction C2: Morphologic CRp	3.3 Percentage of participants Interval 0.08 to 17.0	0.0 Percentage of participants Interval 0.0 to 10.89	—	—
Percentage of Participants With Complete Remission (CR) End of Consolidation CR	36.7 Percentage of participants Interval 19.93 to 56.14	43.8 Percentage of participants Interval 26.36 to 62.34	—	—
Percentage of Participants With Complete Remission (CR) End of Consolidation Morphologic CRp	3.3 Percentage of participants Interval 0.08 to 17.22	9.4 Percentage of participants Interval 1.98 to 25.02	—	—
Percentage of Participants With Complete Remission (CR) After treatment discontinuation CR	10.0 Percentage of participants Interval 2.11 to 26.53	3.1 Percentage of participants Interval 0.08 to 16.22	—	—
Percentage of Participants With Complete Remission (CR) After treatment discontinuation Morphologic CRp	0.0 Percentage of participants Interval 0.0 to 11.57	6.3 Percentage of participants Interval 0.77 to 20.81	—	—

SECONDARY outcome

Timeframe: up to 3 years after last patient started treatment

CIR (only for patients who achieved CR after study treatment initiation), is measured from the date of first CR to relapse or death due to AML, whichever occurs first.

Outcome measures

Outcome measures
Measure	Midostaurin: Part 1 (Japan Only) n=30 Participants Part 1 was conducted to evaluate the safety and tolerability of midostaurin in combination with daunorubicin/cytarabine induction and high-dose cytarabine consolidation in Japanese patients. The safety evaluation period began on Day 1 of the first induction cycle (Cycle 1 Day 1) and continued until Day 21 of the first consolidation cycle.	Midostaurin: Part 2 n=32 Participants Patients took study drug on day 8-21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase	Placebo: Part 2 Patients took Placebo on day 8 - 21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase.	Other Participants These participants were not randomized to any treatment but received chemotherapy and died during the study. This group also includes 1 participant who was randomized to placebo but did not receive placebo and died during the on-treatment period.
Percentage of Participants With Cumulative Incidence of Relapse (CIR)	21 Participants	25 Participants	—	—

SECONDARY outcome

Timeframe: Induction Phase: Pre-dose and 1, 3, 6 and 12 hours post dose in Cycle 1 Day 8

Population: PK analysis set for full PK (PAS-full): The PAS-full included all subjects in the PAS-all, who provide an evaluable PK profile. A profile was considered evaluable if all of the following conditions are satisfied: Subject received the planned dose of midostaurin on C1D8 of induction therapy; Subject did not vomit within 4 hours of the dosing of midostaurin on C1D8 of induction therapy; Subject provided at least one primary PK parameter.

Evaluate AUClast \& AUC0-t PK parameters for midostaurin. AUClast: The AUC from time zero to the last measurable concentration sampling time (Tlast) (mass x time x volume-1) AUC0-t: The area under the curve (AUC) from time zero to a measurable concentration sampling time (t) (mass x time x volume-1).

Outcome measures

Outcome measures
Measure	Midostaurin: Part 1 (Japan Only) n=34 Participants Part 1 was conducted to evaluate the safety and tolerability of midostaurin in combination with daunorubicin/cytarabine induction and high-dose cytarabine consolidation in Japanese patients. The safety evaluation period began on Day 1 of the first induction cycle (Cycle 1 Day 1) and continued until Day 21 of the first consolidation cycle.	Midostaurin: Part 2 Patients took study drug on day 8-21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase	Placebo: Part 2 Patients took Placebo on day 8 - 21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase.	Other Participants These participants were not randomized to any treatment but received chemotherapy and died during the study. This group also includes 1 participant who was randomized to placebo but did not receive placebo and died during the on-treatment period.
Pharmakinetics (PK) for Midostaurin: AUClast & AUC0-t AUC0-t	19200 ng*hr/mL Geometric Coefficient of Variation 49.0	—	—	—
Pharmakinetics (PK) for Midostaurin: AUClast & AUC0-t AUClast	17900 ng*hr/mL Geometric Coefficient of Variation 53.5	—	—	—

SECONDARY outcome

Timeframe: Induction Phase: Pre-dose and 1, 3, 6 and 12 hours post dose in Cycle 1 Day 8

Population: PAS-full: PK analysis set for full PK (PAS-full): The PAS-full included all subjects in the PAS-all, who provide an evaluable PK profile. A profile was considered evaluable if all of the following conditions are satisfied: Subject received the planned dose of midostaurin on C1D8 of induction therapy; Subject did not vomit within 4 hours of the dosing of midostaurin on C1D8 of induction therapy; Subject provided at least one primary PK parameter.

Evaluate Cmax parameter for midostaurin. Cmax: The maximum (peak) observed plasma drug concentration after the first dose administration of midostaurin (mass x volume-1).

Outcome measures

Outcome measures
Measure	Midostaurin: Part 1 (Japan Only) n=34 Participants Part 1 was conducted to evaluate the safety and tolerability of midostaurin in combination with daunorubicin/cytarabine induction and high-dose cytarabine consolidation in Japanese patients. The safety evaluation period began on Day 1 of the first induction cycle (Cycle 1 Day 1) and continued until Day 21 of the first consolidation cycle.	Midostaurin: Part 2 Patients took study drug on day 8-21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase	Placebo: Part 2 Patients took Placebo on day 8 - 21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase.	Other Participants These participants were not randomized to any treatment but received chemotherapy and died during the study. This group also includes 1 participant who was randomized to placebo but did not receive placebo and died during the on-treatment period.
Pharmakinetics (PK) for Midostaurin: Cmax	2420 ng/mL Geometric Coefficient of Variation 46.5	—	—	—

SECONDARY outcome

Timeframe: Induction Phase: Cycle 1 Day 8

Evaluate the pharmacokinetic of major metabolite of midostaurin CGP52421. AUClast: The AUC from time zero to the last measurable concentration sampling time (Tlast) (mass x time x volume-1) AUC0-t: The area under the curve (AUC) from time zero to a measurable concentration sampling time (t) (mass x time x volume-1).

Outcome measures

Outcome measures
Measure	Midostaurin: Part 1 (Japan Only) n=34 Participants Part 1 was conducted to evaluate the safety and tolerability of midostaurin in combination with daunorubicin/cytarabine induction and high-dose cytarabine consolidation in Japanese patients. The safety evaluation period began on Day 1 of the first induction cycle (Cycle 1 Day 1) and continued until Day 21 of the first consolidation cycle.	Midostaurin: Part 2 Patients took study drug on day 8-21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase	Placebo: Part 2 Patients took Placebo on day 8 - 21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase.	Other Participants These participants were not randomized to any treatment but received chemotherapy and died during the study. This group also includes 1 participant who was randomized to placebo but did not receive placebo and died during the on-treatment period.
Metabolite CGP52421: PK Parameters AUClast, AUC0-t AUClast	754 ng*hr/mL Geometric Coefficient of Variation 116	—	—	—
Metabolite CGP52421: PK Parameters AUClast, AUC0-t AUC0-t	876 ng*hr/mL Geometric Coefficient of Variation 92.3	—	—	—

SECONDARY outcome

Timeframe: Induction Phase: Cycle 1 Day 8

Evaluate the pharmacokinetic of major metabolite of midostaurin CGP52421: Cmax. Cmax: The maximum (peak) observed plasma drug concentration after the first dose administration of midostaurin (mass x volume-1).

Outcome measures

Outcome measures
Measure	Midostaurin: Part 1 (Japan Only) n=34 Participants Part 1 was conducted to evaluate the safety and tolerability of midostaurin in combination with daunorubicin/cytarabine induction and high-dose cytarabine consolidation in Japanese patients. The safety evaluation period began on Day 1 of the first induction cycle (Cycle 1 Day 1) and continued until Day 21 of the first consolidation cycle.	Midostaurin: Part 2 Patients took study drug on day 8-21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase	Placebo: Part 2 Patients took Placebo on day 8 - 21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase.	Other Participants These participants were not randomized to any treatment but received chemotherapy and died during the study. This group also includes 1 participant who was randomized to placebo but did not receive placebo and died during the on-treatment period.
Metabolite CGP52421: PK Parameter Cmax	98.6 ng/mL Geometric Coefficient of Variation 83.5	—	—	—

SECONDARY outcome

Timeframe: Induction Phase: Cycle 1 Day 8

Evaluate the pharmacokinetic of major metabolite of Midostaurin CGP62221 PK parameters AUClast, AUC0-t

Outcome measures

Outcome measures
Measure	Midostaurin: Part 1 (Japan Only) n=34 Participants Part 1 was conducted to evaluate the safety and tolerability of midostaurin in combination with daunorubicin/cytarabine induction and high-dose cytarabine consolidation in Japanese patients. The safety evaluation period began on Day 1 of the first induction cycle (Cycle 1 Day 1) and continued until Day 21 of the first consolidation cycle.	Midostaurin: Part 2 Patients took study drug on day 8-21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase	Placebo: Part 2 Patients took Placebo on day 8 - 21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase.	Other Participants These participants were not randomized to any treatment but received chemotherapy and died during the study. This group also includes 1 participant who was randomized to placebo but did not receive placebo and died during the on-treatment period.
Metabolite CGP62221: PK Parameters: AUClast, AUC0-t AUClast	1430 ng*hr/mL Geometric Coefficient of Variation 223	—	—	—
Metabolite CGP62221: PK Parameters: AUClast, AUC0-t AUC0-t	1730 ng*hr/mL Geometric Coefficient of Variation 182	—	—	—

SECONDARY outcome

Timeframe: Induction Phase: Cycle 1 Day 8

Evaluate the pharmacokinetic of major metabolite of Midostaurin CGP62221 PK parameter Cmax. Cmax: The maximum (peak) observed plasma drug concentration after the first dose administration of midostaurin (mass x volume-1).

Outcome measures

Outcome measures
Measure	Midostaurin: Part 1 (Japan Only) n=34 Participants Part 1 was conducted to evaluate the safety and tolerability of midostaurin in combination with daunorubicin/cytarabine induction and high-dose cytarabine consolidation in Japanese patients. The safety evaluation period began on Day 1 of the first induction cycle (Cycle 1 Day 1) and continued until Day 21 of the first consolidation cycle.	Midostaurin: Part 2 Patients took study drug on day 8-21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase	Placebo: Part 2 Patients took Placebo on day 8 - 21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase.	Other Participants These participants were not randomized to any treatment but received chemotherapy and died during the study. This group also includes 1 participant who was randomized to placebo but did not receive placebo and died during the on-treatment period.
Metabolite CGP62221: PK Parameter: Cmax	196 ng/mL Geometric Coefficient of Variation 159	—	—	—

SECONDARY outcome

Timeframe: EOI: up to 1.84 months (after 2 cycles); EOCons: up to 5.52 months (after 4 cycles); EOCont: up to 16.56 months (after 12 cycles); EOT: up to 16.56 months maximum, depending on treatment duration; each cycle = 28 days

Population: Participants in the full analysis set (FAS) with an available assessment for the outcome measure at each timepoint. FAS: The FAS comprised of all subjects to whom study drug (midostaurin/placebo) had been assigned by randomization.

The EORTC QLQ-C30 is a 30-item questionnaire with multi-item scales and single-item measures, including five functional scales (physical, role, emotional, cognitive, and social), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact), and a global health status/QoL scale. Scores range from 0 to 100, with higher scores indicating higher response levels. High functional scale scores denote healthy functioning, high global QoL scores indicate high QoL, and high symptom scores reflect high symptom levels. Scoring follows the EORTC Scoring Manual, reported by absolute change from baseline. EOI = End of Induction; EOCons = End of Consolidation; EOCont = End of Continuation; EOT = End of Treatment.

Outcome measures

Outcome measures
Measure	Midostaurin: Part 1 (Japan Only) n=17 Participants Part 1 was conducted to evaluate the safety and tolerability of midostaurin in combination with daunorubicin/cytarabine induction and high-dose cytarabine consolidation in Japanese patients. The safety evaluation period began on Day 1 of the first induction cycle (Cycle 1 Day 1) and continued until Day 21 of the first consolidation cycle.	Midostaurin: Part 2 n=20 Participants Patients took study drug on day 8-21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase	Placebo: Part 2 Patients took Placebo on day 8 - 21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase.	Other Participants These participants were not randomized to any treatment but received chemotherapy and died during the study. This group also includes 1 participant who was randomized to placebo but did not receive placebo and died during the on-treatment period.
Change From Baseline in Quality of Life (QoL) Per European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 EOI: Global health status (GHS):GHS	27.8 scores on a scale Standard Deviation 31.03	0.0 scores on a scale Standard Deviation 16.67	—	—
Change From Baseline in Quality of Life (QoL) Per European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 EOCons: GHS:GHS	20.8 scores on a scale Standard Deviation 11.49	37.1 scores on a scale Standard Deviation 24.54	—	—
Change From Baseline in Quality of Life (QoL) Per European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 EOCont: GHS:GHS	28.3 scores on a scale Standard Deviation 22.52	27.8 scores on a scale Standard Deviation 10.09	—	—
Change From Baseline in Quality of Life (QoL) Per European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 EOT:GHS:GHS	25.5 scores on a scale Standard Deviation 21.94	28.8 scores on a scale Standard Deviation 23.33	—	—

SECONDARY outcome

The PGIC is a single self-reported item that asks about change in status of subject's overall satisfaction with medication since starting the standalone study. The specific wording of the PGIC is "Directions: Circle the one number that best describes how your overall satisfaction with your medication had changed since starting the study": "Very much improved" =1; "Much improved" =2; "Minimally improved" =3; "No change" =4; "Minimally worse" =5; "Much worse" =6; "Very much worse" =7. PGI-C questions have been widely used to assess the patient perspective of improvement in clinical trials and have shown clinical validity in a variety of indications, including depression, urinary incontinence and adult asthma and the PGIC score determined frequencies and percentages by scheduled timepoint. EOI = End of Induction; EOCons = End of Consolidation; EOCont = End of Continuation; EOT = End of Treatment.

Outcome measures

Outcome measures
Measure	Midostaurin: Part 1 (Japan Only) n=18 Participants Part 1 was conducted to evaluate the safety and tolerability of midostaurin in combination with daunorubicin/cytarabine induction and high-dose cytarabine consolidation in Japanese patients. The safety evaluation period began on Day 1 of the first induction cycle (Cycle 1 Day 1) and continued until Day 21 of the first consolidation cycle.	Midostaurin: Part 2 n=20 Participants Patients took study drug on day 8-21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase	Placebo: Part 2 Patients took Placebo on day 8 - 21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase.	Other Participants These participants were not randomized to any treatment but received chemotherapy and died during the study. This group also includes 1 participant who was randomized to placebo but did not receive placebo and died during the on-treatment period.
Quality of Life (QoL) Per Patient Global Impression of Change (PGIC) EOI: Minimally improved	3 Participants	0 Participants	—	—
Quality of Life (QoL) Per Patient Global Impression of Change (PGIC) EOI: No change	1 Participants	1 Participants	—	—
Quality of Life (QoL) Per Patient Global Impression of Change (PGIC) EOCont: Much improved	0 Participants	4 Participants	—	—
Quality of Life (QoL) Per Patient Global Impression of Change (PGIC) EOT: Minimally improved	6 Participants	4 Participants	—	—
Quality of Life (QoL) Per Patient Global Impression of Change (PGIC) EOT: Minimally worse	0 Participants	2 Participants	—	—
Quality of Life (QoL) Per Patient Global Impression of Change (PGIC) EOI: Very much improved	1 Participants	0 Participants	—	—
Quality of Life (QoL) Per Patient Global Impression of Change (PGIC) EOI: Much improved	2 Participants	1 Participants	—	—
Quality of Life (QoL) Per Patient Global Impression of Change (PGIC) EOI: Minimally worse	0 Participants	1 Participants	—	—
Quality of Life (QoL) Per Patient Global Impression of Change (PGIC) EOCons: Very much improved	1 Participants	1 Participants	—	—
Quality of Life (QoL) Per Patient Global Impression of Change (PGIC) EOCons: Much improved	2 Participants	3 Participants	—	—
Quality of Life (QoL) Per Patient Global Impression of Change (PGIC) EOCons: Minimally improved	2 Participants	4 Participants	—	—
Quality of Life (QoL) Per Patient Global Impression of Change (PGIC) EOCons: No change	1 Participants	2 Participants	—	—
Quality of Life (QoL) Per Patient Global Impression of Change (PGIC) EOCons: Minimally worse	0 Participants	1 Participants	—	—
Quality of Life (QoL) Per Patient Global Impression of Change (PGIC) EOCont: Very much improved	3 Participants	2 Participants	—	—
Quality of Life (QoL) Per Patient Global Impression of Change (PGIC) EOCont: Minimally improved	1 Participants	0 Participants	—	—
Quality of Life (QoL) Per Patient Global Impression of Change (PGIC) EOCont: No change	1 Participants	0 Participants	—	—
Quality of Life (QoL) Per Patient Global Impression of Change (PGIC) EOT: Very much improved	5 Participants	3 Participants	—	—
Quality of Life (QoL) Per Patient Global Impression of Change (PGIC) EOT: Much improved	4 Participants	8 Participants	—	—
Quality of Life (QoL) Per Patient Global Impression of Change (PGIC) EOT: No change	3 Participants	3 Participants	—	—

POST_HOC outcome

Timeframe: Start of study treatment up to 30 days post-treatment for approx. 1 year, prior to study treatment (before randomization) up to LPLV, approx. 55 months

Population: Clinical Database Population: all enrolled participants

Pre-treatment deaths were collected from screening visit up to the first day of treatment, for a maximum duration of 21 days. Participants who died during the screening period are considered as screen failures. On-treatment deaths were collected from start of treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of approx. 55 months. Post-treatment survival follow-up deaths were collected after the on-treatment period up to approx. 36 months. Participants who did not die during the on-treatment period and had not stopped study participation at the time of data cut-off (when study was terminated) were censored.

Outcome measures

Outcome measures
Measure	Midostaurin: Part 1 (Japan Only) n=5 Participants Part 1 was conducted to evaluate the safety and tolerability of midostaurin in combination with daunorubicin/cytarabine induction and high-dose cytarabine consolidation in Japanese patients. The safety evaluation period began on Day 1 of the first induction cycle (Cycle 1 Day 1) and continued until Day 21 of the first consolidation cycle.	Midostaurin: Part 2 n=30 Participants Patients took study drug on day 8-21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase	Placebo: Part 2 n=31 Participants Patients took Placebo on day 8 - 21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase.	Other Participants n=7 Participants These participants were not randomized to any treatment but received chemotherapy and died during the study. This group also includes 1 participant who was randomized to placebo but did not receive placebo and died during the on-treatment period.
All Collected Deaths Total Deaths in study	3 Participants	10 Participants	7 Participants	7 Participants
All Collected Deaths Deaths on-treatment	1 Participants	3 Participants	1 Participants	0 Participants
All Collected Deaths Deaths - Not randomized to any treatment but received chemotherapy	0 Participants	0 Participants	0 Participants	6 Participants
All Collected Deaths Post-treatment survival follow-up deaths	2 Participants	7 Participants	6 Participants	0 Participants
All Collected Deaths Deaths - Randomized to placebo but did not receive drug	0 Participants	0 Participants	0 Participants	1 Participants

Adverse Events

Midostaurin: Part 1 (Japan Only) (On-treatment)

Serious events: 2 serious events

Other events: 5 other events

Deaths: 1 deaths

Midostaurin: Part 2 (On-treatment)

Serious events: 12 serious events

Other events: 30 other events

Deaths: 3 deaths

Placebo Part 2 (On-treatment)

Serious events: 10 serious events

Other events: 31 other events

Deaths: 1 deaths

Midostaurin: Part 1 (Japan Only) (Post-treatment Survival Follow-up)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Midostaurin: Part 2 (Post-treatment Survival Follow-up)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 7 deaths

Placebo: Part 2 (Post-treatment Survival Follow-up)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 6 deaths

Other Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Midostaurin: Part 1 (Japan Only) (On-treatment) n=5 participants at risk Part 1 was conducted to evaluate the safety and tolerability of midostaurin in combination with daunorubicin/cytarabine induction and high-dose cytarabine consolidation in Japanese patients. The safety evaluation period began on Day 1 of the first induction cycle (Cycle 1 Day 1) and continued until Day 21 of the first consolidation cycle.	Midostaurin: Part 2 (On-treatment) n=30 participants at risk Patients took study drug on day 8-21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase.	Placebo Part 2 (On-treatment) n=31 participants at risk Patients took Placebo on day 8 - 21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase. This group excludes the 1 participant who was randomized to placebo but did not receive placebo and died during the on-treatment period.	Midostaurin: Part 1 (Japan Only) (Post-treatment Survival Follow-up) Deaths collected in the post- treatment survival follow-up in Part 1 phase (starting from day 31 post- treatment in Part 1). No AEs were collected during this period.	Midostaurin: Part 2 (Post-treatment Survival Follow-up) Deaths collected in the post- treatment survival follow-up phase (starting from day 31 post- treatment). No AEs were collected during this period.	Placebo: Part 2 (Post-treatment Survival Follow-up) Deaths collected in the post- treatment survival follow-up phase (starting from day 31 post- treatment). No AEs were collected during this period.	Other Participants These participants were not randomized to any treatment but received chemotherapy and died during the study. This group also includes 1 participant who was randomized to placebo but did not receive placebo and died during the on-treatment period.
Blood and lymphatic system disorders Febrile neutropenia	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.2% 1/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.2% 1/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Cardiac disorders Cardiac failure	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Cardiac disorders Cardiac failure acute	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Cardiac disorders Cardio-respiratory arrest	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Gastrointestinal disorders Necrotising colitis	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Gastrointestinal disorders Proctitis	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
General disorders Multiple organ dysfunction syndrome	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
General disorders Pyrexia	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Immune system disorders Anaphylactic reaction	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.2% 1/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Candida infection	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.2% 1/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Escherichia sepsis	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.2% 1/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Fungaemia	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.2% 1/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Osteomyelitis	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.2% 1/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Periodontitis	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Pneumonia	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	16.7% 5/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Sepsis	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	10.0% 3/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.2% 1/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Septic shock	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.2% 1/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Investigations Neutrophil count decreased	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.2% 1/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Investigations Platelet count decreased	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.2% 1/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.2% 1/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).

Other adverse events

Other adverse events
Measure	Midostaurin: Part 1 (Japan Only) (On-treatment) n=5 participants at risk Part 1 was conducted to evaluate the safety and tolerability of midostaurin in combination with daunorubicin/cytarabine induction and high-dose cytarabine consolidation in Japanese patients. The safety evaluation period began on Day 1 of the first induction cycle (Cycle 1 Day 1) and continued until Day 21 of the first consolidation cycle.	Midostaurin: Part 2 (On-treatment) n=30 participants at risk Patients took study drug on day 8-21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase.	Placebo Part 2 (On-treatment) n=31 participants at risk Patients took Placebo on day 8 - 21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase. This group excludes the 1 participant who was randomized to placebo but did not receive placebo and died during the on-treatment period.	Midostaurin: Part 1 (Japan Only) (Post-treatment Survival Follow-up) Deaths collected in the post- treatment survival follow-up in Part 1 phase (starting from day 31 post- treatment in Part 1). No AEs were collected during this period.	Midostaurin: Part 2 (Post-treatment Survival Follow-up) Deaths collected in the post- treatment survival follow-up phase (starting from day 31 post- treatment). No AEs were collected during this period.	Placebo: Part 2 (Post-treatment Survival Follow-up) Deaths collected in the post- treatment survival follow-up phase (starting from day 31 post- treatment). No AEs were collected during this period.	Other Participants These participants were not randomized to any treatment but received chemotherapy and died during the study. This group also includes 1 participant who was randomized to placebo but did not receive placebo and died during the on-treatment period.
Blood and lymphatic system disorders Anaemia	60.0% 3/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	56.7% 17/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	48.4% 15/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Blood and lymphatic system disorders Febrile neutropenia	80.0% 4/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	83.3% 25/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	67.7% 21/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Blood and lymphatic system disorders Leukopenia	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Blood and lymphatic system disorders Neutropenia	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	20.0% 6/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	22.6% 7/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Blood and lymphatic system disorders Pancytopenia	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	33.3% 10/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	9.7% 3/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Cardiac disorders Cardiac failure	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Cardiac disorders Cardiac hypertrophy	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Cardiac disorders Supraventricular tachycardia	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Cardiac disorders Tachycardia	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Eye disorders Dry eye	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Eye disorders Eye pain	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Gastrointestinal disorders Abdominal distension	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Gastrointestinal disorders Abdominal pain	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	10.0% 3/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	19.4% 6/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Gastrointestinal disorders Abdominal pain upper	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	33.3% 10/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	12.9% 4/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Gastrointestinal disorders Constipation	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	33.3% 10/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	45.2% 14/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Gastrointestinal disorders Dental caries	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Gastrointestinal disorders Diarrhoea	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	66.7% 20/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	54.8% 17/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Gastrointestinal disorders Dyspepsia	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Gastrointestinal disorders Gastrointestinal mucosal disorder	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Gastrointestinal disorders Gingival bleeding	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Gastrointestinal disorders Gingival pain	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	10.0% 3/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Gastrointestinal disorders Haemorrhoids	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	16.7% 5/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	9.7% 3/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Gastrointestinal disorders Intestinal haemorrhage	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Gastrointestinal disorders Mouth ulceration	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	9.7% 3/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Gastrointestinal disorders Nausea	100.0% 5/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	56.7% 17/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	54.8% 17/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Gastrointestinal disorders Neutropenic colitis	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Gastrointestinal disorders Proctalgia	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	10.0% 3/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Gastrointestinal disorders Stomatitis	60.0% 3/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	30.0% 9/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	32.3% 10/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Gastrointestinal disorders Toothache	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.2% 1/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Gastrointestinal disorders Vomiting	60.0% 3/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	26.7% 8/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	45.2% 14/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
General disorders Asthenia	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	10.0% 3/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
General disorders Catheter site erythema	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
General disorders Catheter site pain	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
General disorders Fatigue	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
General disorders Generalised oedema	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	12.9% 4/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
General disorders Malaise	80.0% 4/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	10.0% 3/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
General disorders Oedema	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.2% 1/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
General disorders Oedema peripheral	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	9.7% 3/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
General disorders Pain	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
General disorders Pyrexia	80.0% 4/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	43.3% 13/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	61.3% 19/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Hepatobiliary disorders Hepatic failure	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Hepatobiliary disorders Hepatic function abnormal	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	9.7% 3/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Immune system disorders Hypersensitivity	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Bacteraemia	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Bronchitis	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Catheter site cellulitis	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Cellulitis	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.2% 1/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Cellulitis of male external genital organ	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Clostridium difficile colitis	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Clostridium difficile infection	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	9.7% 3/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Conjunctivitis	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Device related infection	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	9.7% 3/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Ecthyma	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Enterocolitis infectious	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Escherichia bacteraemia	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Gingivitis	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	10.0% 3/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.2% 1/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Hepatosplenic candidiasis	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Herpes zoster	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Periodontitis	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	9.7% 3/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Pharyngitis	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Pneumonia	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	20.0% 6/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	22.6% 7/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Pneumonia fungal	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.2% 1/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Sepsis	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	13.3% 4/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	9.7% 3/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Sinusitis	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.2% 1/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Skin infection	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Infections and infestations Upper respiratory tract infection	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	9.7% 3/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Investigations Blood alkaline phosphatase increased	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Injury, poisoning and procedural complications Allergic transfusion reaction	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Injury, poisoning and procedural complications Fall	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Injury, poisoning and procedural complications Infusion related reaction	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Injury, poisoning and procedural complications Procedural pain	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.2% 1/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	16.1% 5/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Injury, poisoning and procedural complications Wound complication	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Investigations Alanine aminotransferase increased	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	36.7% 11/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	22.6% 7/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Investigations Amylase increased	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Investigations Antithrombin III decreased	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Investigations Aspartate aminotransferase increased	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	20.0% 6/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	16.1% 5/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Investigations Blood bilirubin increased	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	16.1% 5/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Investigations Blood creatinine increased	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Investigations Coagulation test abnormal	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Investigations Electrocardiogram QT prolonged	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Investigations Full blood count increased	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Investigations Gamma-glutamyltransferase increased	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	13.3% 4/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.2% 1/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Investigations Immunoglobulins decreased	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Investigations Lymphocyte count decreased	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	9.7% 3/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Investigations Neutrophil count decreased	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	36.7% 11/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	51.6% 16/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Investigations Platelet count decreased	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	46.7% 14/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	58.1% 18/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Investigations Ventilation/perfusion scan abnormal	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Investigations Weight decreased	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	20.0% 6/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	22.6% 7/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Investigations Weight increased	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Investigations White blood cell count decreased	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	36.7% 11/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	48.4% 15/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Metabolism and nutrition disorders Decreased appetite	60.0% 3/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	20.0% 6/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	22.6% 7/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Metabolism and nutrition disorders Fluid retention	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	10.0% 3/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	9.7% 3/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Metabolism and nutrition disorders Hypoalbuminaemia	60.0% 3/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.2% 1/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Metabolism and nutrition disorders Hypocalcaemia	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Metabolism and nutrition disorders Hypokalaemia	60.0% 3/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	23.3% 7/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	35.5% 11/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	9.7% 3/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Metabolism and nutrition disorders Hypophosphataemia	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.2% 1/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Musculoskeletal and connective tissue disorders Arthralgia	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	13.3% 4/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	9.7% 3/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Musculoskeletal and connective tissue disorders Back pain	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	13.3% 4/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	12.9% 4/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	12.9% 4/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.2% 1/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	9.7% 3/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Nervous system disorders Dizziness	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	10.0% 3/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Nervous system disorders Dysgeusia	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	10.0% 3/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.2% 1/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Nervous system disorders Head discomfort	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Nervous system disorders Headache	60.0% 3/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	26.7% 8/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	25.8% 8/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Nervous system disorders Hypoaesthesia	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Nervous system disorders Presyncope	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Psychiatric disorders Delirium	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Psychiatric disorders Insomnia	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	16.7% 5/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	32.3% 10/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Renal and urinary disorders Acute kidney injury	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Renal and urinary disorders Haematuria	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	9.7% 3/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	16.7% 5/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	25.8% 8/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.2% 1/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	12.9% 4/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Respiratory, thoracic and mediastinal disorders Hypoxia	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	16.1% 5/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	12.9% 4/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Skin and subcutaneous tissue disorders Alopecia	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	23.3% 7/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	9.7% 3/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Skin and subcutaneous tissue disorders Dry skin	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	10.0% 3/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	9.7% 3/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Skin and subcutaneous tissue disorders Erythema	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Skin and subcutaneous tissue disorders Pruritus	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	16.7% 5/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	12.9% 4/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Skin and subcutaneous tissue disorders Rash	40.0% 2/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	33.3% 10/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	58.1% 18/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Skin and subcutaneous tissue disorders Rash papular	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	26.7% 8/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	9.7% 3/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Vascular disorders Flushing	20.0% 1/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Vascular disorders Haematoma	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Vascular disorders Hypertension	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	10.0% 3/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Vascular disorders Hypotension	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	12.9% 4/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).
Vascular disorders Phlebitis	0.00% 0/5 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	6.5% 2/31 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 55 months. Deaths were collected in the post-treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 36 months. These are not considered AEs An Adverse Event is any sign or symptom occurring during a trial and safety follow-up, excluding deaths in post-treatment survival follow-up. The total at risk includes patients entering post-treatment survival after the 30-day post-treatment period. Death data was reported for all enrolled patients, while Adverse Events data was reported from those receiving at least one dose of the study drug (midostaurin/placebo).

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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 pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
Publication restrictions are in place

Restriction type: OTHER