Trial Outcomes & Findings for Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia (NCT NCT02003222)

NCT ID: NCT02003222

Last Updated: 2025-11-10

Results Overview

Overall survival is defined as the time from randomization to death of any cause.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 488 participants
• Primary outcome timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years
• Results posted on: 2025-11-10

Participant Flow

This study was activated on December 17, 2013 and closed to accrual on October 15, 2019 after enrolling a total of 488 patients.

Participant milestones

Measure	MRD Negative - Blinatumomab + Chemotherapy MRD negative patients received induction treatment and intensification treatment and then were randomized to receive blinatumomab plus chemotherapy.	MRD Negative - Chemotherapy MRD negative patients received induction treatment and intensification treatment and then were randomized to receive chemotherapy.	MRD Positive - Blinatumomab + Chemotherapy MRD positive patients received induction treatment and intensification treatment and then were randomized or assigned to receive blinatumomab plus chemotherapy.	MRD Positive - Chemotherapy MRD positive patients received induction treatment and intensification treatment and then were randomized to receive chemotherapy.	No Randomization/Registration Patients were registered to receive induction treatment and intensification treatment but did not enter the randomization part of the study.
Induction STARTED	112	112	40	22	202
Induction Received Treatment and Adverse Event Assessment Available	112	112	40	22	193
Induction COMPLETED	112	112	40	22	47
Induction NOT COMPLETED	0	0	0	0	155
Intensification STARTED	112	112	40	22	47
Intensification Received Treatment and Adverse Event Assessment Available	112	112	40	22	30
Intensification COMPLETED	112	112	40	22	0
Intensification NOT COMPLETED	0	0	0	0	47
Randomization/Registration STARTED	112	112	40	22	0
Randomization/Registration Received Treatment and Adverse Event Assessment Available	111	110	35	16	0
Randomization/Registration COMPLETED	112	112	40	22	0
Randomization/Registration NOT COMPLETED	0	0	0	0	0
Maintenance STARTED	67	69	13	2	0
Maintenance Received Treatment and Adverse Event Assessment Available	66	68	12	2	0
Maintenance COMPLETED	67	69	13	2	0
Maintenance NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Measure	MRD Negative - Blinatumomab + Chemotherapy MRD negative patients received induction treatment and intensification treatment and then were randomized to receive blinatumomab plus chemotherapy.	MRD Negative - Chemotherapy MRD negative patients received induction treatment and intensification treatment and then were randomized to receive chemotherapy.	MRD Positive - Blinatumomab + Chemotherapy MRD positive patients received induction treatment and intensification treatment and then were randomized or assigned to receive blinatumomab plus chemotherapy.	MRD Positive - Chemotherapy MRD positive patients received induction treatment and intensification treatment and then were randomized to receive chemotherapy.	No Randomization/Registration Patients were registered to receive induction treatment and intensification treatment but did not enter the randomization part of the study.
Induction Never started treatment	0	0	0	0	8
Induction Complete remission or complete remission incomplete not achieved	0	0	0	0	67
Induction Adverse Event	0	0	0	0	13
Induction Alternative therapy	0	0	0	0	12
Induction Disease progression	0	0	0	0	22
Induction Death	0	0	0	0	3
Induction Withdrawal by Subject	0	0	0	0	8
Induction Other reasons	0	0	0	0	22
Intensification Never started treatment	0	0	0	0	2
Intensification Adverse Event	0	0	0	0	6
Intensification Alternative therapy	0	0	0	0	8
Intensification Disease progression	0	0	0	0	18
Intensification Withdrawal by Subject	0	0	0	0	5
Intensification Other reasons	0	0	0	0	8

Baseline Characteristics

Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia

Baseline characteristics by cohort

Measure	MRD Negative - Blinatumomab + Chemotherapy n=112 Participants MRD negative patients received induction treatment and intensification treatment and then were randomized to receive blinatumomab plus chemotherapy.	MRD Negative - Chemotherapy n=112 Participants MRD negative patients received induction treatment and intensification treatment and then were randomized to receive chemotherapy.	MRD Positive - Blinatumomab + Chemotherapy n=40 Participants MRD positive patients received induction treatment and intensification treatment and then were randomized or assigned to receive blinatumomab plus chemotherapy.	MRD Positive - Chemotherapy n=22 Participants MRD positive patients received induction treatment and intensification treatment and then were randomized to receive chemotherapy.	No Randomization/Registration n=202 Participants Patients were registered to receive induction treatment and intensification treatment but did not enter the randomization part of the study.	Total n=488 Participants Total of all reporting groups
Age, Continuous	51.5 years n=5 Participants	50 years n=20 Participants	49 years n=40 Participants	54.5 years n=28 Participants	52 years n=46 Participants	51 years n=34 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	56 Participants n=20 Participants	26 Participants n=40 Participants	8 Participants n=28 Participants	90 Participants n=46 Participants	237 Participants n=34 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	56 Participants n=20 Participants	14 Participants n=40 Participants	14 Participants n=28 Participants	112 Participants n=46 Participants	251 Participants n=34 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	10 Participants n=20 Participants	8 Participants n=40 Participants	5 Participants n=28 Participants	34 Participants n=46 Participants	70 Participants n=34 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	95 Participants n=5 Participants	95 Participants n=20 Participants	30 Participants n=40 Participants	16 Participants n=28 Participants	155 Participants n=46 Participants	391 Participants n=34 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	7 Participants n=20 Participants	2 Participants n=40 Participants	1 Participants n=28 Participants	13 Participants n=46 Participants	27 Participants n=34 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants	5 Participants n=46 Participants	8 Participants n=34 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=20 Participants	1 Participants n=40 Participants	0 Participants n=28 Participants	4 Participants n=46 Participants	10 Participants n=34 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants	0 Participants n=46 Participants	1 Participants n=34 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	4 Participants n=20 Participants	3 Participants n=40 Participants	1 Participants n=28 Participants	6 Participants n=46 Participants	23 Participants n=34 Participants
Race (NIH/OMB) White	87 Participants n=5 Participants	89 Participants n=20 Participants	30 Participants n=40 Participants	21 Participants n=28 Participants	164 Participants n=46 Participants	391 Participants n=34 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants	2 Participants n=46 Participants	2 Participants n=34 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	16 Participants n=20 Participants	6 Participants n=40 Participants	0 Participants n=28 Participants	21 Participants n=46 Participants	53 Participants n=34 Participants

PRIMARY outcome

Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years

Population: All MRD-negative patients randomized to either blinatumomab + chemotherapy or chemotherapy alone were included in this analysis.

Overall survival is defined as the time from randomization to death of any cause.

Outcome measures

Measure	MRD Negative - Blinatumomab + Chemotherapy n=112 Participants MRD negative patients received induction treatment and intensification treatment and then were randomized to receive blinatumomab plus chemotherapy.	MRD Negative - Chemotherapy n=112 Participants MRD negative patients received induction treatment and intensification treatment and then were randomized to receive chemotherapy.
Overall Survival (OS) Among Patients Who Were MRD Negative After Induction and Intensification Chemotherapy	NA months Median OS not reached The 95% confidence intervals were not calculable because an insufficient number of participants reached the event at the final time point for assessment.	NA months Interval 66.5 to Median OS not reached The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.

SECONDARY outcome

Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years

Population: All MRD-negative patients randomized to either blinatumomab + chemotherapy or chemotherapy alone were included in this analysis.

RFS was defined as time from randomization to relapse or to death without documentation of relapse. Patients without events were censored at the date of last disease assessment.

Relapse/Persistent Disease

Persistent disease/Relapse following complete remission (CR)/complete remission incomplete (CRi) is defined as:

• Reappearance or persistence of blasts in the blood
• Presence of > 5% blasts, not attributable to another cause (e.g., bone marrow regeneration).
• In the case of isolated CNS relapse such as a positive cytospin examination of CSF, please consult with Study Chair. Perform bone marrow biopsy (if not already done) to confirm presence or lack of medullary relapse.

Outcome measures

Measure	MRD Negative - Blinatumomab + Chemotherapy n=112 Participants MRD negative patients received induction treatment and intensification treatment and then were randomized to receive blinatumomab plus chemotherapy.	MRD Negative - Chemotherapy n=112 Participants MRD negative patients received induction treatment and intensification treatment and then were randomized to receive chemotherapy.
Relapse-free Survival (RFS) Among Patients Who Were MRD Negative After Induction and Intensification Chemotherapy	NA months Interval 37.1 to Median RFS not reached The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.	35.2 months Interval 30.3 to 69.0

SECONDARY outcome

Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years

Population: Patients with MRD data at the end of 2 cycles of blinatumomab were included in the analysis.

RFS was defined as time from end of 2 cycles of blinatumomab to relapse or to death without documentation of relapse. Patients without events were censored at the date of last disease assessment.

Relapse/Persistent Disease

Persistent disease/Relapse following complete remission (CR)/complete remission incomplete (CRi) is defined as:

• Reappearance or persistence of blasts in the blood
• Presence of > 5% blasts, not attributable to another cause (e.g., bone marrow regeneration).
• In the case of isolated CNS relapse such as a positive cytospin examination of CSF, please consult with Study Chair. Perform bone marrow biopsy (if not already done) to confirm presence or lack of medullary relapse.

Outcome measures

Measure	MRD Negative - Blinatumomab + Chemotherapy n=28 Participants MRD negative patients received induction treatment and intensification treatment and then were randomized to receive blinatumomab plus chemotherapy.	MRD Negative - Chemotherapy n=89 Participants MRD negative patients received induction treatment and intensification treatment and then were randomized to receive chemotherapy.
RFS Among of Those Who Are MRD+ at Randomization and Then Convert to MRD- After 2 Cycles of Blinatumomab to Those Patients Who Are MRD- at Randomization and Remain MRD- After 2 Cycles of Blinatumomab or Consolidation Chemotherapy	NA months Median RFS not reached The 95% confidence intervals were not calculable because an insufficient number of participants reached the event at the final time point for assessment.	NA months Interval 38.9 to Median RFS not reached The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.

SECONDARY outcome

Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years

Population: Patients with MRD data at the end of 2 cycles of blinatumomab were included in the analysis.

OS was defined as time from end of 2 cycles of blinatumomab to death of any cause

Outcome measures

Measure	MRD Negative - Blinatumomab + Chemotherapy n=28 Participants MRD negative patients received induction treatment and intensification treatment and then were randomized to receive blinatumomab plus chemotherapy.	MRD Negative - Chemotherapy n=89 Participants MRD negative patients received induction treatment and intensification treatment and then were randomized to receive chemotherapy.
OS Among of Those Who Are MRD+ at Randomization and Then Convert to MRD- After 2 Cycles of Blinatumomab to Those Patients Who Are MRD- at Randomization and Remain MRD- After 2 Cycles of Blinatumomab or Consolidation Chemotherapy	NA months Median OS not reached The 95% confidence intervals were not calculable because an insufficient number of participants reached the event at the final time point for assessment.	NA months Median OS not reached The 95% confidence intervals were not calculable because an insufficient number of participants reached the event at the final time point for assessment.

SECONDARY outcome

Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years

Population: MRD negative patients who proceeded to allogeneic transplant after treatment with blinatumomab plus chemotherapy or chemotherapy alone were included in this analysis.

OS was defined as time from allogeneic transplant to death of any cause.

Outcome measures

Measure	MRD Negative - Blinatumomab + Chemotherapy n=22 Participants MRD negative patients received induction treatment and intensification treatment and then were randomized to receive blinatumomab plus chemotherapy.	MRD Negative - Chemotherapy n=22 Participants MRD negative patients received induction treatment and intensification treatment and then were randomized to receive chemotherapy.
OS Among MRD Negative Patients Who Proceed to Allogeneic Transplant on Study	NA months Median OS not reached The 95% confidence intervals were not calculable because an insufficient number of participants reached the event at the final time point for assessment.	NA months Interval 30.2 to Median OS not reached The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years

To determine differences in MRD kinetics among patients with the BCR/ABL1-like B-lineage ALL, and to compare the OS (and RFS) of patients with BCR-ABL-like phenotype with those without BCR-ABLlike phenotype

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at baseline, end of 2 cycles of blinatumomab, end of 4 cycles of blinatumomab, and end of blinatumomab treatment

To evaluate the incidence of anti-blinatumomab antibody formation

Outcome measures

Outcome data not reported

Adverse Events

Induction

Serious events: 457 serious events

Other events: 227 other events

Deaths: 103 deaths

Intensification

Serious events: 166 serious events

Other events: 153 other events

Deaths: 28 deaths

Blinatumomab

Serious events: 134 serious events

Other events: 94 other events

Deaths: 23 deaths

No Blinatumomab

Serious events: 121 serious events

Other events: 65 other events

Deaths: 31 deaths

Maintenance

Serious events: 121 serious events

Other events: 93 other events

Deaths: 27 deaths

Serious adverse events

Measure	Induction n=479 participants at risk Patients receive cytarabine intrathecally (IT) on day 1; daunorubicin hydrochloride intravenously (IV) over 10-15 minutes on days 1, 8, 15, and 22; vincristine sulfate IV on days 1, 8, 15, and 22; dexamethasone orally (PO) daily on days 1-7 (and 15-21 for patients age \< 55 years only); methotrexate IT on day 14; pegaspargase intramuscularly (IM) or IV on day 18 (patients age \< 55 years); and CD20 positive patients may optionally receive rituximab IV on day 8 and 15. Beginning on day 29, patients with absolute neutrophil count (ANC) \>= 0.75 x 10\^9/L and platelets \> 75 x 10\^9/L (patients with delayed hematologic recovery) (patients with residual disease that is delaying count begin treatment immediately) receive cyclophosphamide IV over 30 minutes on days 1 and 29, cytarabine IV over 30 minutes or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO on days 1-14, 29-42, pegaspargase IM or IV on day 15 (patients age \< 55 years), patients receiving treatment for central nervous system (CNS) 2 or 3 leukemia in cycle 1 receive methotrexate IT on days 1, 8, 15, and 22, and CD20 positive patients may optionally receive rituximab IV on days 8 and 15.	Intensification n=316 participants at risk Beginning 4 weeks after the completion of cycle 2 of induction therapy, patients receive intensification therapy comprising high-dose methotrexate IV over 2 hours on days 1 and 8, and pegaspargase IM or IV on day 9.	Blinatumomab n=146 participants at risk Patients receive blinatumomab IV continuously on days 1-28. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients may then undergo allogeneic stem cell transplant (SCT) or proceed to consolidation therapy per investigator discretion. Consolidation therapy: Beginning after the second cycle of blinatumomab, patients receive cytarabine IV over 30 minutes or SC on days 1-5, etoposide IV over 1 hour on days 1-5, methotrexate IT on day 1, and pegaspargase IM or IV on day 5, and CD20 positive patients may optionally receive rituximab IV on day 5. Beginning 4 weeks from day 1 of cycle 1, patients receive cytarabine, etoposide, methotrexate, and CD20 positive patients may receive rituximab as in cycle 1. Beginning 4 weeks from day 1 of cycle 2, patients receive daunorubicin hydrochloride IV over 10-15 minutes on day 1, 8, 15, 22; vincristine sulfate IV on days 1, 8, 15, 22; dexamethasone PO daily on days 1-7 (and 15-21 for patients age \< 55 years); methotrexate IT on day 2; cyclophosphamide IV over 30 minutes on day 29; cytarabine IV over 30 minutes or SC on days 30-33 and 37-40; mercaptopurine PO on days 29-42 and CD20 positive patients may receive rituximab on day 8. Beginning 8 weeks from day 1 of cycle 3, patients receive cytarabine, etoposide, methotrexate, and CD20 positive patients may optionally receive rituximab as in cycle 1. Patients repeat cycle 4 and then receive blinatumomab IV continuously on days 1-28.	No Blinatumomab n=126 participants at risk Patients undergo allogeneic stem cell transplant (SCT) or proceed to consolidation therapy per investigator discretion. Consolidation therapy: After intensification therapy, patients receive cytarabine IV over 30 minutes or SC on days 1-5, etoposide IV over 1 hour on days 1-5, methotrexate IT on day 1, and pegaspargase IM or IV on day 5, and CD20 positive patients may optionally receive rituximab IV on day 5. Beginning 4 weeks from day 1 of cycle 1, patients receive cytarabine, etoposide, methotrexate, and CD20 positive patients may receive rituximab as in cycle 1. Beginning 4 weeks from day 1 of cycle 2, patients receive daunorubicin hydrochloride IV over 10-15 minutes on day 1, 8, 15, and 22; vincristine sulfate IV on days 1, 8, 15, and 22; dexamethasone PO daily on days 1-7 (and 15-21 for patients age \< 55 years); methotrexate IT on day 2; cyclophosphamide IV over 30 minutes on day 29; cytarabine IV over 30 minutes or SC on days 30-33 and 37-40; mercaptopurine PO on days 29-42 and CD20 positive patients may receive rituximab on day 8. Beginning 8 weeks from day 1 of cycle 3, patients receive cytarabine, etoposide, methotrexate, and CD20 positive patients may optionally receive rituximab as in cycle 1.	Maintenance n=148 participants at risk Within 6 weeks after beginning last cycle of consolidation therapy, patients receive mercaptopurine PO daily, methotrexate PO or IV over 2 hours once weekly for 2.5 years, vincristine sulfate IV on day 1 every 3 months, prednisone PO on days 1-5 every 3 months, and methotrexate IT on day 1 every 3 months. Treatment continues for up to 2.5 years in the absence of disease progression or unacceptable toxicity.
Ear and labyrinth disorders Ear pain	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Blood and lymphatic system disorders Anemia	50.9% 244/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	17.7% 56/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	26.0% 38/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	39.7% 50/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	11.5% 17/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Blood and lymphatic system disorders Febrile neutropenia	25.9% 124/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	21.2% 31/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	27.0% 34/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	6.8% 10/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Blood and lymphatic system disorders Leukocytosis	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	1.0% 5/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Cardiac disorders Sinus bradycardia	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Cardiac disorders Atrial fibrillation	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.4% 2/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Cardiac disorders Cardiac arrest	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Cardiac disorders Chest pain - cardiac	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Cardiac disorders Left ventricular systolic dysfunction	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Cardiac disorders Myocardial infarction	0.42% 2/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Cardiac disorders Pericarditis	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Cardiac disorders Sinus tachycardia	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.4% 2/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
General disorders Chills	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
General disorders Edema limbs	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
General disorders Fatigue	6.1% 29/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.3% 4/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	3.4% 5/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	4.0% 5/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.0% 3/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
General disorders Fever	1.3% 6/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.4% 2/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
General disorders Flu like symptoms	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
General disorders Gait disturbance	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
General disorders Infusion related reaction	1.0% 5/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
General disorders Localized edema	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
General disorders Multi-organ failure	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
General disorders Non-cardiac chest pain	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
General disorders Pain	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
General disorders General disorders and administration site conditions - Other, specify	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Skin and subcutaneous tissue disorders Erythema multiforme	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Skin and subcutaneous tissue disorders Urticaria	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Colitis	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.4% 2/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Abdominal pain	2.7% 13/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.3% 4/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.1% 3/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.6% 2/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.4% 2/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Anal mucositis	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Ascites	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Constipation	0.63% 3/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Diarrhea	1.5% 7/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.95% 3/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	3.4% 5/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.4% 3/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.4% 2/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Dry mouth	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Dysphagia	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Enterocolitis	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Esophagitis	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Gastric hemorrhage	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Gastritis	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Mucositis oral	1.0% 5/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.63% 2/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	3.2% 4/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	3.4% 5/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Nausea	4.0% 19/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.3% 4/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	4.1% 6/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.6% 2/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.0% 3/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Oral hemorrhage	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Oral pain	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Pancreatitis	1.9% 9/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.3% 4/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.0% 3/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Proctitis	0.42% 2/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Rectal mucositis	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Rectal pain	0.42% 2/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Small intestinal mucositis	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Small intestinal obstruction	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Typhlitis	0.42% 2/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Vomiting	3.5% 17/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.1% 3/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	3.2% 4/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.4% 2/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.63% 3/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Hepatobiliary disorders Cholecystitis	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Hepatobiliary disorders Hepatic failure	0.84% 4/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Immune system disorders Allergic reaction	0.42% 2/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Immune system disorders Anaphylaxis	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Immune system disorders Cytokine release syndrome	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	4.1% 6/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Immune system disorders Serum sickness	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Immune system disorders Immune system disorders - Other, specify	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Infections and infestations Abdominal infection	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Infections and infestations Appendicitis	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Infections and infestations Appendicitis perforated	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Infections and infestations Bone infection	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Infections and infestations Bronchial infection	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Infections and infestations Catheter related infection	1.9% 9/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.95% 3/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.7% 4/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	4.0% 5/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Infections and infestations Endocarditis infective	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Infections and infestations Enterocolitis infectious	0.84% 4/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.4% 2/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Infections and infestations Esophageal infection	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Infections and infestations Eye infection	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Infections and infestations Hepatic infection	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Infections and infestations Lung infection	3.5% 17/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.1% 3/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.6% 2/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.7% 4/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Infections and infestations Meningitis	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Infections and infestations Otitis externa	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Infections and infestations Pancreas infection	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Infections and infestations Pleural infection	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Infections and infestations Sepsis	4.6% 22/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.63% 2/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	5.5% 8/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	7.1% 9/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Infections and infestations Sinusitis	0.84% 4/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.4% 2/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Infections and infestations Skin infection	1.0% 5/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Infections and infestations Soft tissue infection	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Infections and infestations Upper respiratory infection	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	3.2% 4/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Infections and infestations Urinary tract infection	2.1% 10/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.4% 2/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.7% 4/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Infections and infestations Infections and infestations - Other, specify	2.9% 14/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	3.4% 5/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	3.2% 4/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	4.1% 6/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Injury, poisoning and procedural complications Vascular access complication	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Investigations Activated partial thromboplastin time prolonged	0.42% 2/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Investigations Alanine aminotransferase increased	11.7% 56/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	4.7% 15/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	5.5% 8/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	5.6% 7/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	19.6% 29/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Investigations Alkaline phosphatase increased	3.3% 16/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.95% 3/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Investigations Aspartate aminotransferase increased	6.3% 30/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.8% 9/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	3.4% 5/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.4% 3/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	6.8% 10/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Investigations Blood bilirubin increased	10.9% 52/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.9% 6/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.4% 2/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.6% 2/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	7.4% 11/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Investigations Cholesterol high	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Investigations Creatinine increased	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Investigations Fibrinogen decreased	3.8% 18/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.63% 2/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Investigations GGT increased	1.5% 7/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.1% 3/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Investigations Lipase increased	1.0% 5/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.3% 4/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Investigations Lymphocyte count decreased	27.8% 133/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	11.7% 37/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	26.7% 39/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	27.8% 35/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	15.5% 23/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Investigations Lymphocyte count increased	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Investigations Neutrophil count decreased	88.3% 423/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	26.9% 85/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	80.8% 118/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	92.1% 116/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	59.5% 88/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Investigations Platelet count decreased	80.4% 385/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	11.1% 35/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	63.7% 93/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	75.4% 95/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	24.3% 36/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Investigations Serum amylase increased	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Investigations Weight gain	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.4% 2/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Investigations Weight loss	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Investigations White blood cell decreased	82.9% 397/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	7.3% 23/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	44.5% 65/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	61.9% 78/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	33.1% 49/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Investigations Investigations - Other, specify	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Metabolism and nutrition disorders Alkalosis	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Metabolism and nutrition disorders Anorexia	1.5% 7/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.4% 2/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.4% 3/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Metabolism and nutrition disorders Dehydration	1.7% 8/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.1% 3/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Metabolism and nutrition disorders Glucose intolerance	0.63% 3/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Metabolism and nutrition disorders Hyperglycemia	7.9% 38/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	5.1% 16/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	6.2% 9/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	7.1% 9/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.7% 4/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Metabolism and nutrition disorders Hyperkalemia	0.42% 2/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Metabolism and nutrition disorders Hypertriglyceridemia	4.0% 19/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.2% 7/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.7% 4/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	4.0% 5/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Metabolism and nutrition disorders Hyperuricemia	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Metabolism and nutrition disorders Hypoalbuminemia	1.9% 9/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Metabolism and nutrition disorders Hypocalcemia	0.84% 4/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Metabolism and nutrition disorders Hypokalemia	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.3% 4/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.4% 2/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Metabolism and nutrition disorders Hyponatremia	4.2% 20/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.4% 2/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Metabolism and nutrition disorders Hypophosphatemia	1.5% 7/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.4% 2/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.4% 3/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Metabolism and nutrition disorders Iron overload	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Metabolism and nutrition disorders Tumor lysis syndrome	4.8% 23/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.63% 2/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	0.42% 2/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Musculoskeletal and connective tissue disorders Avascular necrosis	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.0% 3/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Musculoskeletal and connective tissue disorders Back pain	0.63% 3/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	1.7% 8/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Musculoskeletal and connective tissue disorders Neck pain	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Musculoskeletal and connective tissue disorders Trismus	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Nervous system disorders Dizziness	0.84% 4/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Nervous system disorders Arachnoiditis	0.42% 2/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Nervous system disorders Ataxia	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.4% 2/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Nervous system disorders Cerebrospinal fluid leakage	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Nervous system disorders Cognitive disturbance	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.1% 3/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Nervous system disorders Concentration impairment	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Nervous system disorders Depressed level of consciousness	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.4% 2/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Nervous system disorders Dysarthria	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.1% 3/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Nervous system disorders Dysphasia	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	4.8% 7/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Nervous system disorders Encephalopathy	1.0% 5/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.4% 2/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Nervous system disorders Headache	5.0% 24/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.63% 2/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	4.1% 6/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	4.8% 6/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.4% 2/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Nervous system disorders Intracranial hemorrhage	0.42% 2/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Nervous system disorders Paresthesia	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Nervous system disorders Peripheral motor neuropathy	0.42% 2/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.6% 2/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.7% 4/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Nervous system disorders Seizure	0.42% 2/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.4% 2/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Nervous system disorders Somnolence	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Nervous system disorders Stroke	0.84% 4/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Nervous system disorders Syncope	0.84% 4/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.7% 4/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Nervous system disorders Tremor	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	3.4% 5/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Nervous system disorders Vasovagal reaction	0.42% 2/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Nervous system disorders Nervous system disorders - Other, specify	0.42% 2/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.7% 4/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.4% 2/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.4% 2/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Eye disorders Cataract	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Eye disorders Eye pain	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Eye disorders Retinopathy	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Psychiatric disorders Anxiety	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Psychiatric disorders Confusion	0.84% 4/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	4.1% 6/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Psychiatric disorders Delirium	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Psychiatric disorders Depression	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.6% 2/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Psychiatric disorders Insomnia	0.42% 2/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Psychiatric disorders Personality change	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Psychiatric disorders Restlessness	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.5% 7/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.42% 2/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Respiratory, thoracic and mediastinal disorders Hiccups	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.84% 4/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.4% 2/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.84% 4/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Respiratory, thoracic and mediastinal disorders Sore throat	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Respiratory, thoracic and mediastinal disorders Wheezing	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	0.21% 1/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Renal and urinary disorders Acute kidney injury	0.84% 4/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.1% 3/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Renal and urinary disorders Hematuria	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Renal and urinary disorders Renal and urinary disorders - Other, specify	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Vascular disorders Capillary leak syndrome	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.68% 1/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Vascular disorders Hematoma	0.42% 2/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Vascular disorders Hypertension	3.5% 17/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.3% 4/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.1% 3/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.4% 2/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Vascular disorders Hypotension	2.7% 13/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.32% 1/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.1% 3/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Vascular disorders Thromboembolic event	4.6% 22/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.63% 2/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.4% 2/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.4% 3/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.4% 2/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.

Other adverse events

Measure	Induction n=479 participants at risk Patients receive cytarabine intrathecally (IT) on day 1; daunorubicin hydrochloride intravenously (IV) over 10-15 minutes on days 1, 8, 15, and 22; vincristine sulfate IV on days 1, 8, 15, and 22; dexamethasone orally (PO) daily on days 1-7 (and 15-21 for patients age \< 55 years only); methotrexate IT on day 14; pegaspargase intramuscularly (IM) or IV on day 18 (patients age \< 55 years); and CD20 positive patients may optionally receive rituximab IV on day 8 and 15. Beginning on day 29, patients with absolute neutrophil count (ANC) \>= 0.75 x 10\^9/L and platelets \> 75 x 10\^9/L (patients with delayed hematologic recovery) (patients with residual disease that is delaying count begin treatment immediately) receive cyclophosphamide IV over 30 minutes on days 1 and 29, cytarabine IV over 30 minutes or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO on days 1-14, 29-42, pegaspargase IM or IV on day 15 (patients age \< 55 years), patients receiving treatment for central nervous system (CNS) 2 or 3 leukemia in cycle 1 receive methotrexate IT on days 1, 8, 15, and 22, and CD20 positive patients may optionally receive rituximab IV on days 8 and 15.	Intensification n=316 participants at risk Beginning 4 weeks after the completion of cycle 2 of induction therapy, patients receive intensification therapy comprising high-dose methotrexate IV over 2 hours on days 1 and 8, and pegaspargase IM or IV on day 9.	Blinatumomab n=146 participants at risk Patients receive blinatumomab IV continuously on days 1-28. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients may then undergo allogeneic stem cell transplant (SCT) or proceed to consolidation therapy per investigator discretion. Consolidation therapy: Beginning after the second cycle of blinatumomab, patients receive cytarabine IV over 30 minutes or SC on days 1-5, etoposide IV over 1 hour on days 1-5, methotrexate IT on day 1, and pegaspargase IM or IV on day 5, and CD20 positive patients may optionally receive rituximab IV on day 5. Beginning 4 weeks from day 1 of cycle 1, patients receive cytarabine, etoposide, methotrexate, and CD20 positive patients may receive rituximab as in cycle 1. Beginning 4 weeks from day 1 of cycle 2, patients receive daunorubicin hydrochloride IV over 10-15 minutes on day 1, 8, 15, 22; vincristine sulfate IV on days 1, 8, 15, 22; dexamethasone PO daily on days 1-7 (and 15-21 for patients age \< 55 years); methotrexate IT on day 2; cyclophosphamide IV over 30 minutes on day 29; cytarabine IV over 30 minutes or SC on days 30-33 and 37-40; mercaptopurine PO on days 29-42 and CD20 positive patients may receive rituximab on day 8. Beginning 8 weeks from day 1 of cycle 3, patients receive cytarabine, etoposide, methotrexate, and CD20 positive patients may optionally receive rituximab as in cycle 1. Patients repeat cycle 4 and then receive blinatumomab IV continuously on days 1-28.	No Blinatumomab n=126 participants at risk Patients undergo allogeneic stem cell transplant (SCT) or proceed to consolidation therapy per investigator discretion. Consolidation therapy: After intensification therapy, patients receive cytarabine IV over 30 minutes or SC on days 1-5, etoposide IV over 1 hour on days 1-5, methotrexate IT on day 1, and pegaspargase IM or IV on day 5, and CD20 positive patients may optionally receive rituximab IV on day 5. Beginning 4 weeks from day 1 of cycle 1, patients receive cytarabine, etoposide, methotrexate, and CD20 positive patients may receive rituximab as in cycle 1. Beginning 4 weeks from day 1 of cycle 2, patients receive daunorubicin hydrochloride IV over 10-15 minutes on day 1, 8, 15, and 22; vincristine sulfate IV on days 1, 8, 15, and 22; dexamethasone PO daily on days 1-7 (and 15-21 for patients age \< 55 years); methotrexate IT on day 2; cyclophosphamide IV over 30 minutes on day 29; cytarabine IV over 30 minutes or SC on days 30-33 and 37-40; mercaptopurine PO on days 29-42 and CD20 positive patients may receive rituximab on day 8. Beginning 8 weeks from day 1 of cycle 3, patients receive cytarabine, etoposide, methotrexate, and CD20 positive patients may optionally receive rituximab as in cycle 1.	Maintenance n=148 participants at risk Within 6 weeks after beginning last cycle of consolidation therapy, patients receive mercaptopurine PO daily, methotrexate PO or IV over 2 hours once weekly for 2.5 years, vincristine sulfate IV on day 1 every 3 months, prednisone PO on days 1-5 every 3 months, and methotrexate IT on day 1 every 3 months. Treatment continues for up to 2.5 years in the absence of disease progression or unacceptable toxicity.
General disorders Fever	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	9.6% 14/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.6% 2/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Blood and lymphatic system disorders Anemia	8.8% 42/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	26.3% 83/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	45.9% 67/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	30.2% 38/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	40.5% 60/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
General disorders Fatigue	7.3% 35/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	11.0% 16/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	5.6% 7/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	12.2% 18/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Abdominal pain	7.7% 37/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	5.7% 18/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	4.8% 7/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	8.7% 11/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	10.1% 15/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Constipation	7.1% 34/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Diarrhea	15.0% 72/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	7.6% 24/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	19.2% 28/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	15.1% 19/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	13.5% 20/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Nausea	9.2% 44/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	6.0% 19/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	11.0% 16/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	4.8% 6/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	8.8% 13/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Gastrointestinal disorders Vomiting	20.9% 100/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	10.1% 32/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	21.9% 32/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	17.5% 22/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	8.8% 13/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Immune system disorders Cytokine release syndrome	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	11.0% 16/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Investigations Alanine aminotransferase increased	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	5.5% 8/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.4% 3/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	12.8% 19/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Investigations Aspartate aminotransferase increased	5.4% 26/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	5.1% 16/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	10.8% 16/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Investigations Blood bilirubin increased	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	6.8% 10/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Investigations Lymphocyte count decreased	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	9.5% 14/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Investigations Neutrophil count decreased	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	13.3% 42/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	22.6% 33/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	3.2% 4/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	27.0% 40/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Investigations Platelet count decreased	8.1% 39/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	22.2% 70/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	38.4% 56/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	21.4% 27/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	37.2% 55/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Investigations White blood cell decreased	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	9.5% 14/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Nervous system disorders Headache	25.9% 124/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	8.5% 27/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	30.1% 44/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	20.6% 26/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	15.5% 23/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	6.2% 9/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	2.4% 3/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	11.5% 17/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Nervous system disorders Tremor	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	13.0% 19/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	1.6% 2/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.
Vascular disorders Thromboembolic event	0.00% 0/479 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/316 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	5.5% 8/146 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.79% 1/126 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.	0.00% 0/148 • Assessed every while on treatment and for 30 days after the end of treatment, up to 9 years Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.

Additional Information

Study Statistician

ECOG-ACRIN Statistical Office

Phone: 617-632-3012

Email: eatrials@jimmy.harvard.edu

Results disclosure agreements

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

Restriction type: LTE60