Trial Outcomes & Findings for Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia (NCT NCT02143414)

NCT ID: NCT02143414

Last Updated: 2026-02-06

Results Overview

To evaluate the 3-year overall survival rate in elderly participants with newly diagnosed Ph-negative ALL treated with blinatumomab followed by POMP maintenance. Overall

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 53 participants
• Primary outcome timeframe: From the day of registration on study until death from any cause, assessed at 3 years
• Results posted on: 2026-02-06

Participant Flow

There were 57 total participants registered to the study; 31 in Cohort I and 26 in Cohort II. Four participants, two from each cohort, were deemed ineligible at the start of the study and never received protocol treatment. This left 53 eligible participants; 29 in Cohort II and 24 in Cohort II.

Participant milestones

Measure	Cohort I (Ph-) INDUCTION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients not achieving CR or CRi after Induction, receive blinatumomab IV continuously over 24 hours on days 1-28 in the absence of disease progression or unacceptable toxicity. POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive prednisone PO on days 1-5, vincristine sulfate IV on day 1, mercaptopurine PO on days 1-28, and methotrexate PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. (Closed to accrual 06/29/17) Blinatumomab: Given IV Laboratory Biomarker Analysis: Correlative studies Mercaptopurine: Given PO Methotrexate: Given PO Methotrexate Sodium: Given PO Prednisone: Given PO Vincristine: Given IV Vincristine Sulfate: Given IV	Cohort II (Ph+/Ph-like) INDUCTION: Patients receive dasatinib PO BID on days 1-84 and prednisone PO on days 1-24 with tapering on days 25-32 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 2 cycles in the absence of disease progression or unacceptable toxicity. POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28 and dasatinib PO QD on days 1-42. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive dasatinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive prednisone PO on days 1-5. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV Dasatinib: Given PO Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO
Induction STARTED	29	24
Induction Completed Induction	24	19
Induction COMPLETED	19	18
Induction NOT COMPLETED	10	6
Post-remission STARTED	19	18
Post-remission COMPLETED	14	16
Post-remission NOT COMPLETED	5	2
Maintenance STARTED	14	16
Maintenance COMPLETED	4	0
Maintenance NOT COMPLETED	10	16

Reasons for withdrawal

Measure	Cohort I (Ph-) INDUCTION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients not achieving CR or CRi after Induction, receive blinatumomab IV continuously over 24 hours on days 1-28 in the absence of disease progression or unacceptable toxicity. POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive prednisone PO on days 1-5, vincristine sulfate IV on day 1, mercaptopurine PO on days 1-28, and methotrexate PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. (Closed to accrual 06/29/17) Blinatumomab: Given IV Laboratory Biomarker Analysis: Correlative studies Mercaptopurine: Given PO Methotrexate: Given PO Methotrexate Sodium: Given PO Prednisone: Given PO Vincristine: Given IV Vincristine Sulfate: Given IV	Cohort II (Ph+/Ph-like) INDUCTION: Patients receive dasatinib PO BID on days 1-84 and prednisone PO on days 1-24 with tapering on days 25-32 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 2 cycles in the absence of disease progression or unacceptable toxicity. POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28 and dasatinib PO QD on days 1-42. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive dasatinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive prednisone PO on days 1-5. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV Dasatinib: Given PO Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO
Induction Adverse Event	1	2
Induction Death	1	2
Induction Patient refusal	1	1
Induction Refractory	1	0
Induction Began alternative treatment	1	0
Induction Ineligible for postremission	5	1
Post-remission Adverse Event	0	2
Post-remission Disease progression/relapse	5	0
Maintenance Adverse Event	4	6
Maintenance Disease progression/relapse	3	2
Maintenance Patient refusal	2	1
Maintenance Physician Decision	1	0
Maintenance Death	0	1
Maintenance On protocol treatment	0	6

Baseline Characteristics

Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia

Baseline characteristics by cohort

Measure	Cohort I (Ph-) n=29 Participants INDUCTION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients not achieving CR or CRi after Induction, receive blinatumomab IV continuously over 24 hours on days 1-28 in the absence of disease progression or unacceptable toxicity. POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive prednisone PO on days 1-5, vincristine sulfate IV on day 1, mercaptopurine PO on days 1-28, and methotrexate PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. (Closed to accrual 06/29/17) Blinatumomab: Given IV Laboratory Biomarker Analysis: Correlative studies Mercaptopurine: Given PO Methotrexate: Given PO Methotrexate Sodium: Given PO Prednisone: Given PO Vincristine: Given IV Vincristine Sulfate: Given IV	Cohort II (Ph+/Ph-like) n=24 Participants INDUCTION: Patients receive dasatinib PO BID on days 1-84 and prednisone PO on days 1-24 with tapering on days 25-32 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 2 cycles in the absence of disease progression or unacceptable toxicity. POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28 and dasatinib PO QD on days 1-42. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive dasatinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive prednisone PO on days 1-5. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV Dasatinib: Given PO Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO	Total n=53 Participants Total of all reporting groups
Age, Continuous	75.4 years n=192 Participants	73.5 years n=170 Participants	74.7 years n=185 Participants
Sex: Female, Male Female	7 Participants n=192 Participants	16 Participants n=170 Participants	23 Participants n=185 Participants
Sex: Female, Male Male	22 Participants n=192 Participants	8 Participants n=170 Participants	30 Participants n=185 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=192 Participants	3 Participants n=170 Participants	5 Participants n=185 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=192 Participants	18 Participants n=170 Participants	45 Participants n=185 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=192 Participants	3 Participants n=170 Participants	3 Participants n=185 Participants
Race/Ethnicity, Customized White	28 Participants n=192 Participants	18 Participants n=170 Participants	46 Participants n=185 Participants
Race/Ethnicity, Customized Black	0 Participants n=192 Participants	1 Participants n=170 Participants	1 Participants n=185 Participants
Race/Ethnicity, Customized Asian	1 Participants n=192 Participants	2 Participants n=170 Participants	3 Participants n=185 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=192 Participants	3 Participants n=170 Participants	3 Participants n=185 Participants
Baseline WBC	3.0 10^3 cells/uL n=192 Participants	7.5 10^3 cells/uL n=170 Participants	5.1 10^3 cells/uL n=185 Participants
Baseline Marrow Blasts	87 percentage n=192 Participants	88.5 percentage n=170 Participants	88.4 percentage n=185 Participants

PRIMARY outcome

Timeframe: From the day of registration on study until death from any cause, assessed at 3 years

Population: Only participants in Cohort I were evaluated

To evaluate the 3-year overall survival rate in elderly participants with newly diagnosed Ph-negative ALL treated with blinatumomab followed by POMP maintenance. Overall

Outcome measures

Measure	Cohort I (Ph-) n=29 Participants INDUCTION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients not achieving CR or CRi after Induction, receive blinatumomab IV continuously over 24 hours on days 1-28 in the absence of disease progression or unacceptable toxicity. POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive prednisone PO on days 1-5, vincristine sulfate IV on day 1, mercaptopurine PO on days 1-28, and methotrexate PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. (Closed to accrual 06/29/17) Blinatumomab: Given IV Laboratory Biomarker Analysis: Correlative studies Mercaptopurine: Given PO Methotrexate: Given PO Methotrexate Sodium: Given PO Prednisone: Given PO Vincristine: Given IV Vincristine Sulfate: Given IV	Induction: Cohort II (Ph+/Ph-like) INDUCTION: Patients receive dasatinib PO BID on days 1-84 and prednisone PO on days 1-24 with tapering on days 25-32 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV Dasatinib: Given PO Prednisone: Given PO	Post-remission: Cohort I (Ph-) POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV	Post-remission: Cohort II (Ph+/Ph-like) POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28 and dasatinib PO QD on days 1-42. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV Dasatinib: Given PO	Maintenance: Cohort I (Ph-) MAINTENANCE: Patients receive prednisone PO on days 1-5, vincristine sulfate IV on day 1, mercaptopurine PO on days 1-28, and methotrexate PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. (Closed to accrual 06/29/17) Mercaptopurine: Given PO Methotrexate: Given PO Methotrexate Sodium: Given PO Prednisone: Given PO Vincristine: Given IV Vincristine Sulfate: Given IV	Maintenance: Cohort II (Ph+/Ph-like) MAINTENANCE: Patients receive dasatinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive prednisone PO on days 1-5. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. Dasatinib: Given PO Prednisone: Given PO
Overall Survival Rate (Cohort I)	34 percentage of participants Interval 18.0 to 54.0	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to day 42 of post-remission therapy

Population: Only participants in Cohort II that registered to post-remission were analyzed for dose-limiting toxicities.

Defined as any grade 4 or higher treatment-related, non-hematologic toxicity in the first cycle of post-remission therapy (blinatumomab/dasatinib) graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Only participants with Ph-positive ALL or Ph-like DSMKF ALL were evaluated.

Outcome measures

Measure	Cohort I (Ph-) n=18 Participants INDUCTION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients not achieving CR or CRi after Induction, receive blinatumomab IV continuously over 24 hours on days 1-28 in the absence of disease progression or unacceptable toxicity. POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive prednisone PO on days 1-5, vincristine sulfate IV on day 1, mercaptopurine PO on days 1-28, and methotrexate PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. (Closed to accrual 06/29/17) Blinatumomab: Given IV Laboratory Biomarker Analysis: Correlative studies Mercaptopurine: Given PO Methotrexate: Given PO Methotrexate Sodium: Given PO Prednisone: Given PO Vincristine: Given IV Vincristine Sulfate: Given IV	Induction: Cohort II (Ph+/Ph-like) INDUCTION: Patients receive dasatinib PO BID on days 1-84 and prednisone PO on days 1-24 with tapering on days 25-32 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV Dasatinib: Given PO Prednisone: Given PO	Post-remission: Cohort I (Ph-) POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV	Post-remission: Cohort II (Ph+/Ph-like) POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28 and dasatinib PO QD on days 1-42. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV Dasatinib: Given PO	Maintenance: Cohort I (Ph-) MAINTENANCE: Patients receive prednisone PO on days 1-5, vincristine sulfate IV on day 1, mercaptopurine PO on days 1-28, and methotrexate PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. (Closed to accrual 06/29/17) Mercaptopurine: Given PO Methotrexate: Given PO Methotrexate Sodium: Given PO Prednisone: Given PO Vincristine: Given IV Vincristine Sulfate: Given IV	Maintenance: Cohort II (Ph+/Ph-like) MAINTENANCE: Patients receive dasatinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive prednisone PO on days 1-5. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. Dasatinib: Given PO Prednisone: Given PO
Incidence of Dose-limiting Toxicity (Cohort II)	0 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Duration of treatment and follow up until death or date of primary analysis (about 7.5 years)

Population: Eligible participants who received at least one dose of protocol treatment.

Number of participants with Grade 3-5 adverse events that are possibly, probably or definitely related to study drug are reported by given type of adverse event. Adverse Events reported using CTCAE v 4.0, whereas Serious Adverse Events were reported with CTCAE v 5.0.

Outcome measures

Measure	Cohort I (Ph-) n=29 Participants INDUCTION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients not achieving CR or CRi after Induction, receive blinatumomab IV continuously over 24 hours on days 1-28 in the absence of disease progression or unacceptable toxicity. POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive prednisone PO on days 1-5, vincristine sulfate IV on day 1, mercaptopurine PO on days 1-28, and methotrexate PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. (Closed to accrual 06/29/17) Blinatumomab: Given IV Laboratory Biomarker Analysis: Correlative studies Mercaptopurine: Given PO Methotrexate: Given PO Methotrexate Sodium: Given PO Prednisone: Given PO Vincristine: Given IV Vincristine Sulfate: Given IV	Induction: Cohort II (Ph+/Ph-like) n=24 Participants INDUCTION: Patients receive dasatinib PO BID on days 1-84 and prednisone PO on days 1-24 with tapering on days 25-32 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV Dasatinib: Given PO Prednisone: Given PO	Post-remission: Cohort I (Ph-) n=19 Participants POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV	Post-remission: Cohort II (Ph+/Ph-like) n=18 Participants POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28 and dasatinib PO QD on days 1-42. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV Dasatinib: Given PO	Maintenance: Cohort I (Ph-) n=13 Participants MAINTENANCE: Patients receive prednisone PO on days 1-5, vincristine sulfate IV on day 1, mercaptopurine PO on days 1-28, and methotrexate PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. (Closed to accrual 06/29/17) Mercaptopurine: Given PO Methotrexate: Given PO Methotrexate Sodium: Given PO Prednisone: Given PO Vincristine: Given IV Vincristine Sulfate: Given IV	Maintenance: Cohort II (Ph+/Ph-like) n=16 Participants MAINTENANCE: Patients receive dasatinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive prednisone PO on days 1-5. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. Dasatinib: Given PO Prednisone: Given PO
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Gastrointestinal pain	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Adult respiratory distress syndrome	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Abdominal pain	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Agitation	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Alanine aminotransferase increased	1 Participants	1 Participants	0 Participants	1 Participants	2 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Alkaline phosphatase increased	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Anemia	10 Participants	8 Participants	2 Participants	1 Participants	4 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Anorexia	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Aspartate aminotransferase increased	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Atrial flutter	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Blood bilirubin increased	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Cataract	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Catheter related infection	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Colitis	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Confusion	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Cytokine release syndrome	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Dehydration	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Diarrhea	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Dizziness	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Dysarthria	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Dyspnea	3 Participants	1 Participants	0 Participants	3 Participants	0 Participants	2 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Edema limbs	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Encephalopathy	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Fatigue	1 Participants	0 Participants	1 Participants	0 Participants	3 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Febrile neutropenia	3 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Fever	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs General disorders and admin site conditions - Other	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Generalized muscle weakness	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Heart failure	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Hematoma	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Hyperglycemia	4 Participants	1 Participants	1 Participants	2 Participants	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Hypertension	3 Participants	0 Participants	1 Participants	2 Participants	1 Participants	4 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Hypoalbuminemia	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Hypocalcemia	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Hypokalemia	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Hypophosphatemia	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Hypotension	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Hypoxia	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Infections and infestations - Other, specify	1 Participants	1 Participants	0 Participants	2 Participants	2 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Infusion related reaction	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Lung infection	2 Participants	2 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Lymphocyte count decreased	8 Participants	6 Participants	2 Participants	6 Participants	4 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Metabolism and nutrition disorders - Other, specify	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Mucositis oral	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Nausea	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Nervous system disorders - Other, specify	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Neutrophil count decreased	10 Participants	9 Participants	5 Participants	10 Participants	11 Participants	3 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Non-cardiac chest pain	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Pericardial effusion	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Platelet count decreased	13 Participants	8 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Pleural effusion	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Pneumonitis	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Pulmonary hypertension	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Rash maculo-papular	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Respiratory failure	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Sepsis	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Soft tissue infection	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Thrombotic thrombocytopenic purpura	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Urinary tract infection	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Vascular access complication	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs Weight loss	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs White blood cell decreased	11 Participants	6 Participants	2 Participants	1 Participants	5 Participants	0 Participants

SECONDARY outcome

Timeframe: Participants are assessed after induction treatment and again after re-induction treatment, if re-induction treatment is received (i.e. up to 85 days after registration)

Population: Only participants in Cohort I were evaluated.

Complete response rate is measured by the number of participants achieving complete remission (CR) or complete remission with incomplete platelet recovery (CRi) rate. CR is defined as having <5% marrow aspirate blasts, ANC >1,000/mcL, platelets > 100,000/mcL, no blasts in peripheral blood, and C1 extramedullary disease status. CRi is the same as CR but platelet count may be <= 100,000/mcL and/or ANC <=1,000/mcL.

Outcome measures

Measure	Cohort I (Ph-) n=29 Participants INDUCTION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients not achieving CR or CRi after Induction, receive blinatumomab IV continuously over 24 hours on days 1-28 in the absence of disease progression or unacceptable toxicity. POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive prednisone PO on days 1-5, vincristine sulfate IV on day 1, mercaptopurine PO on days 1-28, and methotrexate PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. (Closed to accrual 06/29/17) Blinatumomab: Given IV Laboratory Biomarker Analysis: Correlative studies Mercaptopurine: Given PO Methotrexate: Given PO Methotrexate Sodium: Given PO Prednisone: Given PO Vincristine: Given IV Vincristine Sulfate: Given IV	Induction: Cohort II (Ph+/Ph-like) INDUCTION: Patients receive dasatinib PO BID on days 1-84 and prednisone PO on days 1-24 with tapering on days 25-32 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV Dasatinib: Given PO Prednisone: Given PO	Post-remission: Cohort I (Ph-) POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV	Post-remission: Cohort II (Ph+/Ph-like) POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28 and dasatinib PO QD on days 1-42. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV Dasatinib: Given PO	Maintenance: Cohort I (Ph-) MAINTENANCE: Patients receive prednisone PO on days 1-5, vincristine sulfate IV on day 1, mercaptopurine PO on days 1-28, and methotrexate PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. (Closed to accrual 06/29/17) Mercaptopurine: Given PO Methotrexate: Given PO Methotrexate Sodium: Given PO Prednisone: Given PO Vincristine: Given IV Vincristine Sulfate: Given IV	Maintenance: Cohort II (Ph+/Ph-like) MAINTENANCE: Patients receive dasatinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive prednisone PO on days 1-5. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. Dasatinib: Given PO Prednisone: Given PO
Complete Response Rate (Cohort I) CR or CRi	19 Participants	—	—	—	—	—
Complete Response Rate (Cohort I) No CR or CRi	10 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Duration of treatment and follow up until death or date of primary analysis (about 7.5 years)

Population: Only participants in Cohort II that achieved complete remission were analyzable.

An estimate of disease free survival in Ph-positive ALL and Ph-like DSMKF ALL (Cohort II). Disease free survival is measured by the number of years between the date the patient first achieves complete remission (CR) or complete remission with incomplete platelet recovery (CRi) until relapse from CR/CRi or death from any cause. CR is defined as having <5% marrow aspirate blasts, ANC >1,000/mcL, platelets > 100,000/mcL, no blasts in peripheral blood, and C1 extramedullary disease status. CRi is the same as CR but platelet count may be <= 100,000/mcL and/or ANC <=1,000/mcL.

Outcome measures

Measure	Cohort I (Ph-) n=22 Participants INDUCTION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients not achieving CR or CRi after Induction, receive blinatumomab IV continuously over 24 hours on days 1-28 in the absence of disease progression or unacceptable toxicity. POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive prednisone PO on days 1-5, vincristine sulfate IV on day 1, mercaptopurine PO on days 1-28, and methotrexate PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. (Closed to accrual 06/29/17) Blinatumomab: Given IV Laboratory Biomarker Analysis: Correlative studies Mercaptopurine: Given PO Methotrexate: Given PO Methotrexate Sodium: Given PO Prednisone: Given PO Vincristine: Given IV Vincristine Sulfate: Given IV	Induction: Cohort II (Ph+/Ph-like) INDUCTION: Patients receive dasatinib PO BID on days 1-84 and prednisone PO on days 1-24 with tapering on days 25-32 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV Dasatinib: Given PO Prednisone: Given PO	Post-remission: Cohort I (Ph-) POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV	Post-remission: Cohort II (Ph+/Ph-like) POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28 and dasatinib PO QD on days 1-42. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV Dasatinib: Given PO	Maintenance: Cohort I (Ph-) MAINTENANCE: Patients receive prednisone PO on days 1-5, vincristine sulfate IV on day 1, mercaptopurine PO on days 1-28, and methotrexate PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. (Closed to accrual 06/29/17) Mercaptopurine: Given PO Methotrexate: Given PO Methotrexate Sodium: Given PO Prednisone: Given PO Vincristine: Given IV Vincristine Sulfate: Given IV	Maintenance: Cohort II (Ph+/Ph-like) MAINTENANCE: Patients receive dasatinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive prednisone PO on days 1-5. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. Dasatinib: Given PO Prednisone: Given PO
Disease-free Survival (Cohort II)	5.3 years Interval 3.0 to There have not been enough events occurring after the median was reached to estimate the upper limit of the confidence interval.	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 10 years

Estimated using the method of Kaplan-Meier.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants are assessed after induction treatment and again after re-induction treatment, if re-induction treatment is received (i.e. up to 85 days after registration)

Population: Only participants that had achieved CR or CRi and had available MRD data post-treatment were evaluated.

To estimate in each cohort the rate of minimal residual disease (MRD) negativity.

Outcome measures

Measure	Cohort I (Ph-) n=13 Participants INDUCTION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients not achieving CR or CRi after Induction, receive blinatumomab IV continuously over 24 hours on days 1-28 in the absence of disease progression or unacceptable toxicity. POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive prednisone PO on days 1-5, vincristine sulfate IV on day 1, mercaptopurine PO on days 1-28, and methotrexate PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. (Closed to accrual 06/29/17) Blinatumomab: Given IV Laboratory Biomarker Analysis: Correlative studies Mercaptopurine: Given PO Methotrexate: Given PO Methotrexate Sodium: Given PO Prednisone: Given PO Vincristine: Given IV Vincristine Sulfate: Given IV	Induction: Cohort II (Ph+/Ph-like) n=16 Participants INDUCTION: Patients receive dasatinib PO BID on days 1-84 and prednisone PO on days 1-24 with tapering on days 25-32 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV Dasatinib: Given PO Prednisone: Given PO	Post-remission: Cohort I (Ph-) POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV	Post-remission: Cohort II (Ph+/Ph-like) POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28 and dasatinib PO QD on days 1-42. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV Dasatinib: Given PO	Maintenance: Cohort I (Ph-) MAINTENANCE: Patients receive prednisone PO on days 1-5, vincristine sulfate IV on day 1, mercaptopurine PO on days 1-28, and methotrexate PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. (Closed to accrual 06/29/17) Mercaptopurine: Given PO Methotrexate: Given PO Methotrexate Sodium: Given PO Prednisone: Given PO Vincristine: Given IV Vincristine Sulfate: Given IV	Maintenance: Cohort II (Ph+/Ph-like) MAINTENANCE: Patients receive dasatinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive prednisone PO on days 1-5. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. Dasatinib: Given PO Prednisone: Given PO
Minimal Residual Disease Negativity MRD-	12 Participants	7 Participants	—	—	—	—
Minimal Residual Disease Negativity MRD+	1 Participants	9 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Up to 10 years

Will be examined separately in descriptive analyses within each cohort.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 10 years

To determine whether anti-idiotype antibodies directed against blinatumomab develop with blinatumomab treatment in this study.

Outcome measures

Outcome data not reported

Adverse Events

Induction: Cohort I (Ph-)

Serious events: 13 serious events

Other events: 28 other events

Deaths: 1 deaths

Induction: Cohort II (Ph+/Ph-like)

Serious events: 14 serious events

Other events: 24 other events

Deaths: 2 deaths

Post-remission: Cohort I (Ph-)

Serious events: 5 serious events

Other events: 19 other events

Deaths: 0 deaths

Post-remission: Cohort II (Ph+/Ph-like)

Serious events: 10 serious events

Other events: 18 other events

Deaths: 0 deaths

Maintenance: Cohort I (Ph-)

Serious events: 6 serious events

Other events: 13 other events

Deaths: 0 deaths

Maintenance: Cohort II (Ph+/Ph-like)

Serious events: 12 serious events

Other events: 15 other events

Deaths: 1 deaths

Serious adverse events

Measure	Induction: Cohort I (Ph-) n=29 participants at risk INDUCTION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients not achieving CR or CRi after Induction, receive blinatumomab IV continuously over 24 hours on days 1-28 in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV	Induction: Cohort II (Ph+/Ph-like) n=24 participants at risk INDUCTION: Patients receive dasatinib PO BID on days 1-84 and prednisone PO on days 1-24 with tapering on days 25-32 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV Dasatinib: Given PO Prednisone: Given PO	Post-remission: Cohort I (Ph-) n=19 participants at risk POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV	Post-remission: Cohort II (Ph+/Ph-like) n=18 participants at risk POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28 and dasatinib PO QD on days 1-42. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV Dasatinib: Given PO	Maintenance: Cohort I (Ph-) n=13 participants at risk MAINTENANCE: Patients receive prednisone PO on days 1-5, vincristine sulfate IV on day 1, mercaptopurine PO on days 1-28, and methotrexate PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. (Closed to accrual 06/29/17) Mercaptopurine: Given PO Methotrexate: Given PO Methotrexate Sodium: Given PO Prednisone: Given PO Vincristine: Given IV Vincristine Sulfate: Given IV	Maintenance: Cohort II (Ph+/Ph-like) n=16 participants at risk MAINTENANCE: Patients receive dasatinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive prednisone PO on days 1-5. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. Dasatinib: Given PO Prednisone: Given PO
General disorders Death NOS	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Blood and lymphatic system disorders Anemia	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Blood and lymphatic system disorders Febrile neutropenia	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	23.1% 3/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Blood and lymphatic system disorders Leukocytosis	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Cardiac disorders Atrial fibrillation	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Cardiac disorders Atrial flutter	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Cardiac disorders Chest pain - cardiac	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Cardiac disorders Heart failure	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Cardiac disorders Myocardial infarction	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Cardiac disorders Pericardial effusion	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Cardiac disorders Sinus tachycardia	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Cardiac disorders Supraventricular tachycardia	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Eye disorders Eye disorders-Other	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Abdominal pain	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Colitis	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Diarrhea	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 3/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Enterocolitis	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Ileus	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Mucositis oral	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Nausea	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Vomiting	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
General disorders Chills	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
General disorders Edema limbs	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
General disorders Fever	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 3/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	10.5% 2/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	23.1% 3/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
General disorders General disorders and admin site conditions - Other	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
General disorders Infusion related reaction	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
General disorders Non-cardiac chest pain	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Immune system disorders Cytokine release syndrome	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Infections and infestations Catheter related infection	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Infections and infestations Infections and infestations-Other	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 3/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	10.5% 2/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	11.1% 2/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Infections and infestations Lung infection	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Infections and infestations Sepsis	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	23.1% 3/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Infections and infestations Upper respiratory infection	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Infections and infestations Urinary tract infection	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Injury, poisoning and procedural complications Fall	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Injury, poisoning and procedural complications Fracture	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Injury, poisoning and procedural complications Injury, poison and procedural complications - Other	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Injury, poisoning and procedural complications Vascular access complication	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Investigations Alanine aminotransferase increased	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Investigations Creatinine increased	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Investigations Lymphocyte count decreased	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Investigations Neutrophil count decreased	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	10.5% 2/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	11.1% 2/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	23.1% 3/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Investigations Platelet count decreased	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Investigations Weight loss	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Investigations White blood cell decreased	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Metabolism and nutrition disorders Hyperglycemia	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Vascular disorders Hematoma	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tiss disorder - Other	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified - Other	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Nervous system disorders Dysarthria	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Nervous system disorders Encephalopathy	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Nervous system disorders Nervous system disorders-Other	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Nervous system disorders Peripheral sensory neuropathy	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Nervous system disorders Syncope	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Psychiatric disorders Agitation	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Psychiatric disorders Confusion	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	11.1% 2/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Psychiatric disorders Delirium	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Psychiatric disorders Hallucinations	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	10.3% 3/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Vascular disorders Hypertension	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Vascular disorders Hypotension	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Vascular disorders Thromboembolic event	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.

Other adverse events

Measure	Induction: Cohort I (Ph-) n=29 participants at risk INDUCTION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients not achieving CR or CRi after Induction, receive blinatumomab IV continuously over 24 hours on days 1-28 in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV	Induction: Cohort II (Ph+/Ph-like) n=24 participants at risk INDUCTION: Patients receive dasatinib PO BID on days 1-84 and prednisone PO on days 1-24 with tapering on days 25-32 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV Dasatinib: Given PO Prednisone: Given PO	Post-remission: Cohort I (Ph-) n=19 participants at risk POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV	Post-remission: Cohort II (Ph+/Ph-like) n=18 participants at risk POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28 and dasatinib PO QD on days 1-42. Treatment repeats every 42 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Blinatumomab: Given IV Dasatinib: Given PO	Maintenance: Cohort I (Ph-) n=13 participants at risk MAINTENANCE: Patients receive prednisone PO on days 1-5, vincristine sulfate IV on day 1, mercaptopurine PO on days 1-28, and methotrexate PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. (Closed to accrual 06/29/17) Mercaptopurine: Given PO Methotrexate: Given PO Methotrexate Sodium: Given PO Prednisone: Given PO Vincristine: Given IV Vincristine Sulfate: Given IV	Maintenance: Cohort II (Ph+/Ph-like) n=16 participants at risk MAINTENANCE: Patients receive dasatinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive prednisone PO on days 1-5. Treatment repeats every 28 days for 18 cycles in the absence of disease progression or unacceptable toxicity. Dasatinib: Given PO Prednisone: Given PO
Blood and lymphatic system disorders Anemia	58.6% 17/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	54.2% 13/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	47.4% 9/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	66.7% 12/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	69.2% 9/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	56.2% 9/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Blood and lymphatic system disorders Disseminated intravascular coagulation	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Blood and lymphatic system disorders Febrile neutropenia	20.7% 6/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Cardiac disorders Atrial fibrillation	10.3% 3/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	10.5% 2/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Cardiac disorders Atrial flutter	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Cardiac disorders Atrioventricular block first degree	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Cardiac disorders Cardiac disorders-Other	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Cardiac disorders Chest pain - cardiac	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Cardiac disorders Heart failure	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Cardiac disorders Palpitations	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	11.1% 2/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Cardiac disorders Pericardial effusion	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Cardiac disorders Sinus bradycardia	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	11.1% 2/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Cardiac disorders Sinus tachycardia	13.8% 4/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	21.1% 4/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	16.7% 3/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	23.1% 3/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Cardiac disorders Supraventricular tachycardia	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	11.1% 2/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Ear and labyrinth disorders Ear and labyrinth disorders-Other	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Ear and labyrinth disorders Ear pain	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	11.1% 2/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Ear and labyrinth disorders Hearing impaired	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Ear and labyrinth disorders Vertigo	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Endocrine disorders Endocrine disorders-Other	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	18.8% 3/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Endocrine disorders Hyperthyroidism	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Endocrine disorders Hypothyroidism	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Eye disorders Blurred vision	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.8% 3/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	11.1% 2/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	23.1% 3/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Eye disorders Cataract	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Eye disorders Dry eye	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	10.5% 2/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Eye disorders Eye disorders-Other	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	10.5% 2/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	11.1% 2/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	23.1% 3/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Eye disorders Eye pain	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Eye disorders Photophobia	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Eye disorders Retinopathy	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Eye disorders Watering eyes	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Abdominal distension	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Abdominal pain	10.3% 3/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 3/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.8% 3/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	16.7% 3/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	38.5% 5/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	18.8% 3/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Anal hemorrhage	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Bloating	13.8% 4/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Cheilitis	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Colitis	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Constipation	34.5% 10/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	16.7% 4/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	10.5% 2/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	22.2% 4/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	61.5% 8/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	25.0% 4/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Dental caries	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Diarrhea	17.2% 5/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	33.3% 8/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	10.5% 2/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	50.0% 9/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	38.5% 5/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	68.8% 11/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Dry mouth	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Dyspepsia	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	23.1% 3/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Dysphagia	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Enterocolitis	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Esophageal pain	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Esophagitis	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Fecal incontinence	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Flatulence	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Gastritis	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Gastroesophageal reflux disease	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Gastrointestinal disorders-Other	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 3/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	16.7% 3/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	18.8% 3/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Hemorrhoids	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Mucositis oral	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	46.2% 6/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Nausea	27.6% 8/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	25.0% 6/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	26.3% 5/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	38.9% 7/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	30.8% 4/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	56.2% 9/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Oral hemorrhage	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Oral pain	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Rectal ulcer	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Stomach pain	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Toothache	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Gastrointestinal disorders Vomiting	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	10.5% 2/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	22.2% 4/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	23.1% 3/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	25.0% 4/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
General disorders Chills	20.7% 6/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	33.3% 6/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
General disorders Edema face	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
General disorders Edema limbs	41.4% 12/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	41.7% 10/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	31.6% 6/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	66.7% 12/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	30.8% 4/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	56.2% 9/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
General disorders Edema trunk	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	11.1% 2/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
General disorders Fatigue	41.4% 12/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	54.2% 13/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	26.3% 5/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	66.7% 12/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	61.5% 8/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	56.2% 9/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
General disorders Fever	27.6% 8/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	16.7% 4/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.8% 3/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	61.1% 11/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	25.0% 4/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
General disorders Flu like symptoms	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
General disorders Gait disturbance	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	11.1% 2/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
General disorders General disorders and admin site conditions - Other	10.3% 3/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	27.8% 5/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	18.8% 3/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
General disorders Infusion related reaction	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
General disorders Infusion site extravasation	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
General disorders Injection site reaction	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
General disorders Irritability	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
General disorders Localized edema	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	11.1% 2/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
General disorders Malaise	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	11.1% 2/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
General disorders Non-cardiac chest pain	10.3% 3/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 3/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	10.5% 2/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	16.7% 3/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	23.1% 3/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
General disorders Pain	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	16.7% 4/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	21.1% 4/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	16.7% 3/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Hepatobiliary disorders Cholecystitis	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Hepatobiliary disorders Hepatobiliary disorders-Other	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Immune system disorders Allergic reaction	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Immune system disorders Cytokine release syndrome	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	22.2% 4/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Immune system disorders Immune system disorders-Other	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Infections and infestations Conjunctivitis infective	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Infections and infestations Infections and infestations-Other	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	38.5% 5/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Infections and infestations Mucosal infection	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Infections and infestations Lung infection	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Infections and infestations Nail infection	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Infections and infestations Pharyngitis	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Infections and infestations Rash pustular	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Infections and infestations Sinusitis	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Infections and infestations Skin infection	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Infections and infestations Soft tissue infection	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Infections and infestations Upper respiratory infection	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	10.5% 2/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Infections and infestations Urinary tract infection	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Injury, poisoning and procedural complications Bruising	10.3% 3/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 3/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	23.1% 3/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Injury, poisoning and procedural complications Burn	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Injury, poisoning and procedural complications Fall	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	11.1% 2/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Investigations Activated partial thromboplastin time prolonged	10.3% 3/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	10.5% 2/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Investigations Alanine aminotransferase increased	34.5% 10/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	20.8% 5/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	21.1% 4/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	22.2% 4/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	53.8% 7/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Investigations Alkaline phosphatase increased	13.8% 4/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	20.8% 5/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.8% 3/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	16.7% 3/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	23.1% 3/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	25.0% 4/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Investigations Aspartate aminotransferase increased	31.0% 9/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	16.7% 4/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.8% 3/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	22.2% 4/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	61.5% 8/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	18.8% 3/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Investigations Blood bilirubin increased	24.1% 7/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	46.2% 6/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Investigations Cardiac troponin T increased	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Investigations Cholesterol high	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Investigations Creatinine increased	20.7% 6/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	16.7% 4/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	10.5% 2/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	16.7% 3/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	23.1% 3/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	25.0% 4/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Investigations Electrocardiogram QT corrected interval prolonged	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Investigations Fibrinogen decreased	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Investigations INR increased	13.8% 4/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Investigations Investigations-Other	10.3% 3/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	21.1% 4/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	16.7% 3/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	25.0% 4/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Investigations Lymphocyte count decreased	27.6% 8/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	33.3% 8/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	31.6% 6/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	33.3% 6/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	38.5% 5/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Investigations Lymphocyte count increased	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	11.1% 2/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	31.2% 5/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Investigations Neutrophil count decreased	44.8% 13/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	58.3% 14/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	31.6% 6/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	50.0% 9/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	84.6% 11/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	25.0% 4/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Investigations Platelet count decreased	51.7% 15/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	66.7% 16/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	36.8% 7/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	16.7% 3/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	76.9% 10/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Investigations Weight gain	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Investigations Weight loss	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.8% 3/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Investigations White blood cell decreased	51.7% 15/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	50.0% 12/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	36.8% 7/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	50.0% 9/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	53.8% 7/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Metabolism and nutrition disorders Acidosis	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Metabolism and nutrition disorders Anorexia	13.8% 4/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	37.5% 9/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	10.5% 2/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	55.6% 10/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	46.2% 6/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	37.5% 6/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Metabolism and nutrition disorders Dehydration	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Metabolism and nutrition disorders Hyperglycemia	44.8% 13/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	37.5% 9/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	31.6% 6/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	50.0% 9/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	38.5% 5/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	31.2% 5/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Metabolism and nutrition disorders Hyperkalemia	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 3/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Metabolism and nutrition disorders Hypermagnesemia	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Metabolism and nutrition disorders Hypertriglyceridemia	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Metabolism and nutrition disorders Hypoalbuminemia	44.8% 13/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	54.2% 13/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	36.8% 7/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	38.9% 7/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	61.5% 8/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	37.5% 6/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Metabolism and nutrition disorders Hypocalcemia	24.1% 7/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	37.5% 9/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	10.5% 2/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	44.4% 8/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	25.0% 4/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Metabolism and nutrition disorders Hypoglycemia	13.8% 4/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.8% 3/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Metabolism and nutrition disorders Hypokalemia	20.7% 6/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	20.8% 5/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	16.7% 3/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	23.1% 3/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	18.8% 3/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Metabolism and nutrition disorders Hypomagnesemia	17.2% 5/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 3/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.8% 3/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	11.1% 2/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Metabolism and nutrition disorders Hyponatremia	44.8% 13/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 3/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	21.1% 4/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	23.1% 3/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Metabolism and nutrition disorders Hypophosphatemia	10.3% 3/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	33.3% 8/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	33.3% 6/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	18.8% 3/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Musculoskeletal and connective tissue disorders Back pain	24.1% 7/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 3/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	36.8% 7/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	16.7% 3/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	30.8% 4/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Musculoskeletal and connective tissue disorders Bone pain	10.3% 3/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Vascular disorders Flushing	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	10.3% 3/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	20.8% 5/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	10.5% 2/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	16.7% 3/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	23.1% 3/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tiss disorder - Other	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	16.7% 3/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	18.8% 3/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Musculoskeletal and connective tissue disorders Myalgia	10.3% 3/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	10.5% 2/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	17.2% 5/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	10.5% 2/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	16.7% 3/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	46.2% 6/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	25.0% 4/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified - Other	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Nervous system disorders Concentration impairment	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Nervous system disorders Depressed level of consciousness	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Nervous system disorders Dizziness	20.7% 6/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	16.7% 4/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	21.1% 4/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	16.7% 3/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	23.1% 3/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	18.8% 3/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Nervous system disorders Dysarthria	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Nervous system disorders Dysgeusia	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 3/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Nervous system disorders Dysphasia	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Nervous system disorders Encephalopathy	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Nervous system disorders Headache	24.1% 7/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	33.3% 8/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	42.1% 8/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	38.9% 7/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	38.5% 5/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	37.5% 6/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Nervous system disorders Memory impairment	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.8% 3/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	23.1% 3/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Nervous system disorders Nervous system disorders-Other	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Nervous system disorders Paresthesia	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	23.1% 3/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Nervous system disorders Peripheral sensory neuropathy	10.3% 3/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 3/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	10.5% 2/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	22.2% 4/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	53.8% 7/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	18.8% 3/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Nervous system disorders Sinus pain	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Nervous system disorders Tremor	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	10.5% 2/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	27.8% 5/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Psychiatric disorders Agitation	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Psychiatric disorders Anxiety	17.2% 5/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 3/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	10.5% 2/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	11.1% 2/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Psychiatric disorders Confusion	13.8% 4/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.8% 3/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	22.2% 4/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Psychiatric disorders Delirium	10.3% 3/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Psychiatric disorders Depression	10.3% 3/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	10.5% 2/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	23.1% 3/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Psychiatric disorders Hallucinations	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Psychiatric disorders Insomnia	13.8% 4/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	20.8% 5/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	21.1% 4/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	33.3% 6/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	38.5% 5/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	25.0% 4/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Renal and urinary disorders Acute kidney injury	13.8% 4/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Renal and urinary disorders Chronic kidney disease	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Renal and urinary disorders Hematuria	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	11.1% 2/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Renal and urinary disorders Proteinuria	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Renal and urinary disorders Renal and urinary disorders-Other	13.8% 4/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	11.1% 2/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Renal and urinary disorders Renal calculi	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Renal and urinary disorders Renal colic	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Renal and urinary disorders Urinary frequency	17.2% 5/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	11.1% 2/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Renal and urinary disorders Urinary incontinence	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Renal and urinary disorders Urinary retention	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Renal and urinary disorders Urinary urgency	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Reproductive system and breast disorders Prostatic obstruction	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Atelectasis	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Cough	13.8% 4/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	16.7% 4/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	42.1% 8/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	33.3% 6/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	61.5% 8/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	37.5% 6/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	27.6% 8/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	50.0% 12/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.8% 3/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	50.0% 9/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	53.8% 7/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	56.2% 9/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	20.7% 6/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	16.7% 3/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	18.8% 3/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	33.3% 8/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	38.9% 7/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	43.8% 7/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	10.5% 2/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Productive cough	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Resp, thoracic and mediastinal disorders - Other	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	30.8% 4/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Sore throat	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	18.8% 3/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Respiratory, thoracic and mediastinal disorders Wheezing	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Skin and subcutaneous tissue disorders Alopecia	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	10.5% 2/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	30.8% 4/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Skin and subcutaneous tissue disorders Dry skin	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	11.1% 2/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	18.8% 3/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Skin and subcutaneous tissue disorders Erythema multiforme	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Skin and subcutaneous tissue disorders Nail loss	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Skin and subcutaneous tissue disorders Nail ridging	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	11.1% 2/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Skin and subcutaneous tissue disorders Purpura	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	12.5% 2/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Skin and subcutaneous tissue disorders Rash acneiform	3.4% 1/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	11.1% 2/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	20.7% 6/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	25.0% 6/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	26.3% 5/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	11.1% 2/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	23.1% 3/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	25.0% 4/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.8% 3/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	22.2% 4/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	23.1% 3/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	18.8% 3/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Skin and subcutaneous tissue disorders Skin ulceration	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.3% 1/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Surgical and medical procedures Surgical and medical procedures-Other	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	11.1% 2/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	18.8% 3/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Vascular disorders Hot flashes	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Vascular disorders Hypertension	27.6% 8/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	26.3% 5/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	27.8% 5/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	30.8% 4/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	25.0% 4/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Vascular disorders Hypotension	13.8% 4/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	8.3% 2/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	16.7% 3/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	23.1% 3/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Vascular disorders Superficial thrombophlebitis	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	7.7% 1/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Vascular disorders Thromboembolic event	6.9% 2/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	4.2% 1/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	10.5% 2/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	5.6% 1/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	15.4% 2/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.
Vascular disorders Vascular disorders-Other	0.00% 0/29 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/24 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/19 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/18 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	0.00% 0/13 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.	6.2% 1/16 • Duration of treatment and follow up until death or date of primary analysis (about 7.5 years) AEs and SAEs were reported using CTCAE v 4.0 and CTCAE v 5.0, respectively. The analysis populations for Adverse Events and All-Cause Mortality only differ for the Maintenance: Cohort I. The AE population includes participants that received maintenance treatment and thus does not include one participant which relapsed prior to receiving maintenance treatment. Whereas, the All-Cause Mortality population includes all participants registered to receive maintenance treatment.

Additional Information

Leukemia Committee Statistician

SWOG Statistics and Data Management Center

Phone: 2066674623

Email: amoseley@fredhutch.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60