Trial Outcomes & Findings for Rituximab and Combination Chemotherapy in Treating Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma (NCT NCT00118209)

NCT ID: NCT00118209

Last Updated: 2021-11-17

Results Overview

Progression-free survival (PFS) is defined as the time from randomization to progression, relapse, or death from any cause, whichever occurred first. Progression (PD) or Relapse\> * ≥ 50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders.\> * Appearance of any new lesion during or after completion of therapy.\> * PET+ is not a criterion for progressive disease. Patients only with PET+ findings must have evidence of progression on CT or biopsy proven.\> The PFS rate (percentage of participants who are alive and progression-free) at 2 and 5 years Kaplan Meier estimates and 95% Confidence Intervals are reported below.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 524 participants
• Primary outcome timeframe: Up to 5 years post-registration
• Results posted on: 2021-11-17

Participant Flow

Participant milestones

Measure	Arm A - R-CHOP Patients receive the following treatment:\> * Rituximab 375 mg/m\^2 IV infusion on Day 1 prior to CHOP chemotherapy\> * Cyclophosphamide 750 mg/m\^2 IV on Day 1\> * Doxorubicin 50 mg/m\^2 IV on Day 1\> * Vincristine 1.4 mg/m\^2 IV (2 mg cap) on Day 1\> * Prednisone 40 mg/m\^2/day PO on Days 1-5\> * filgrastim or pegfilgrastim as defined in the protocol\> Required ancillary medications is administered during all cycles as defined in the protocol.\> Cycles will be repeated every 21 days for 6 treatment cycles. Restaging will occur after Cycles 4 and 6.	Arm B - DA-EPOCH-R Patients receive the following treatment:\> Cycle 1 Doses:\> * Rituximab 375 mg/m\^2 IV infusion on Day 1 prior to EPOCH chemotherapy\> * Doxorubicin 10 mg/m\^2/day CIVI on Days 1-4\> * Etoposide 50 mg/m\^2/day CIVI on Days 1-4\> * Vincristine 0.4 mg/m\^2/day (no cap) CIVI on Days 1-4 (total 1.6 mg/m2 over 96 hours)\> * Cyclophosphamide 750 mg/m\^2 IV on Day 5 (following completion of 96 hour infusions)\> * Prednisone 60 mg/m\^2 PO BID on Days 1-5\> * Administer filgrastim 480 mcg subcutaneous daily from Day 6 until ANC \> 5000 after the \> nadir (nadir usually between Days 10-12) or for 10 days (Days 6-15) if the ANC is not \> being monitored, during every cycle.\> Doses for subsequent cycles will be determined by the absolute neutrophil (ANC) or platelet nadir from the previous cycle.\> Required ancillary medications are administered during all cycles as defined in the protocol.\> Cycles will be repeated every 21 days for a maximum of 6 cycles. Restaging will occur after Cycles 4 and 6.
Overall Study STARTED	262	262
Overall Study Evaluable for Primary Endpoint	250	241
Overall Study Evaluable for Safety Analysis	243	237
Overall Study COMPLETED	250	241
Overall Study NOT COMPLETED	12	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Number analyzed in row differs from overall due to missing data.

Baseline characteristics by cohort

Measure	Arm A - R-CHOP n=250 Participants Patients receive the following treatment:\> * Rituximab 375 mg/m\^2 IV infusion on Day 1 prior to CHOP chemotherapy\> * Cyclophosphamide 750 mg/m\^2 IV on Day 1\> * Doxorubicin 50 mg/m\^2 IV on Day 1\> * Vincristine 1.4 mg/m\^2 IV (2 mg cap) on Day 1\> * Prednisone 40 mg/m\^2/day PO on Days 1-5\> * filgrastim or pegfilgrastim as defined in the protocol\> Required ancillary medications is administered during all cycles as defined in the protocol.\> Cycles will be repeated every 21 days for 6 treatment cycles. Restaging will occur after Cycles 4 and 6.	Arm B - DA-EPOCH-R n=241 Participants Patients receive the following treatment:\> Cycle 1 Doses:\> * Rituximab 375 mg/m\^2 IV infusion on Day 1 prior to EPOCH chemotherapy\> * Doxorubicin 10 mg/m\^2/day CIVI on Days 1-4\> * Etoposide 50 mg/m\^2/day CIVI on Days 1-4\> * Vincristine 0.4 mg/m\^2/day (no cap) CIVI on Days 1-4 (total 1.6 mg/m2 over 96 hours)\> * Cyclophosphamide 750 mg/m\^2 IV on Day 5 (following completion of 96 hour infusions)\> * Prednisone 60 mg/m\^2 PO BID on Days 1-5\> * Administer filgrastim 480 mcg subcutaneous daily from Day 6 until ANC \> 5000 after the \> nadir (nadir usually between Days 10-12) or for 10 days (Days 6-15) if the ANC is not \> being monitored, during every cycle.\> Doses for subsequent cycles will be determined by the absolute neutrophil (ANC) or platelet nadir from the previous cycle.\> Required ancillary medications are administered during all cycles as defined in the protocol.\> Cycles will be repeated every 21 days for a maximum of 6 cycles. Restaging will occur after Cycles 4 and 6.	Total n=491 Participants Total of all reporting groups
Age, Continuous	58.0 years n=247 Participants • Number analyzed in row differs from overall due to missing data.	58.0 years n=239 Participants • Number analyzed in row differs from overall due to missing data.	58.0 years n=486 Participants • Number analyzed in row differs from overall due to missing data.
Sex: Female, Male Female	116 Participants n=249 Participants • Number analyzed in row differs from overall due to missing data.	109 Participants n=241 Participants • Number analyzed in row differs from overall due to missing data.	225 Participants n=490 Participants • Number analyzed in row differs from overall due to missing data.
Sex: Female, Male Male	133 Participants n=249 Participants • Number analyzed in row differs from overall due to missing data.	132 Participants n=241 Participants • Number analyzed in row differs from overall due to missing data.	265 Participants n=490 Participants • Number analyzed in row differs from overall due to missing data.
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=250 Participants	15 Participants n=241 Participants	31 Participants n=491 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	220 Participants n=250 Participants	214 Participants n=241 Participants	434 Participants n=491 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	14 Participants n=250 Participants	12 Participants n=241 Participants	26 Participants n=491 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=250 Participants	2 Participants n=241 Participants	4 Participants n=491 Participants
Race (NIH/OMB) Asian	9 Participants n=250 Participants	8 Participants n=241 Participants	17 Participants n=491 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=250 Participants	0 Participants n=241 Participants	1 Participants n=491 Participants
Race (NIH/OMB) Black or African American	29 Participants n=250 Participants	31 Participants n=241 Participants	60 Participants n=491 Participants
Race (NIH/OMB) White	196 Participants n=250 Participants	189 Participants n=241 Participants	385 Participants n=491 Participants
Race (NIH/OMB) More than one race	2 Participants n=250 Participants	3 Participants n=241 Participants	5 Participants n=491 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=250 Participants	8 Participants n=241 Participants	19 Participants n=491 Participants
ECOG Performance Status 0	101 Participants n=249 Participants • The number analyzed in row differs from overall due to missing data.	113 Participants n=241 Participants • The number analyzed in row differs from overall due to missing data.	214 Participants n=490 Participants • The number analyzed in row differs from overall due to missing data.
ECOG Performance Status 1	119 Participants n=249 Participants • The number analyzed in row differs from overall due to missing data.	96 Participants n=241 Participants • The number analyzed in row differs from overall due to missing data.	215 Participants n=490 Participants • The number analyzed in row differs from overall due to missing data.
ECOG Performance Status 2	29 Participants n=249 Participants • The number analyzed in row differs from overall due to missing data.	32 Participants n=241 Participants • The number analyzed in row differs from overall due to missing data.	61 Participants n=490 Participants • The number analyzed in row differs from overall due to missing data.

PRIMARY outcome

Timeframe: Up to 5 years post-registration

Progression-free survival (PFS) is defined as the time from randomization to progression, relapse, or death from any cause, whichever occurred first. Progression (PD) or Relapse>

• ≥ 50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders.>
• Appearance of any new lesion during or after completion of therapy.>
• PET+ is not a criterion for progressive disease. Patients only with PET+ findings must have evidence of progression on CT or biopsy proven.>

The PFS rate (percentage of participants who are alive and progression-free) at 2 and 5 years Kaplan Meier estimates and 95% Confidence Intervals are reported below.

Outcome measures

Measure	Arm B - DA-EPOCH-R n=241 Participants Patients receive the following treatment:\> Cycle 1 Doses:\> * Rituximab 375 mg/m\^2 IV infusion on Day 1 prior to EPOCH chemotherapy\> * Doxorubicin 10 mg/m\^2/day CIVI on Days 1-4\> * Etoposide 50 mg/m\^2/day CIVI on Days 1-4\> * Vincristine 0.4 mg/m\^2/day (no cap) CIVI on Days 1-4 (total 1.6 mg/m2 over 96 hours)\> * Cyclophosphamide 750 mg/m\^2 IV on Day 5 (following completion of 96 hour infusions)\> * Prednisone 60 mg/m\^2 PO BID on Days 1-5\> * Administer filgrastim 480 mcg subcutaneous daily from Day 6 until ANC \> 5000 after the \> nadir (nadir usually between Days 10-12) or for 10 days (Days 6-15) if the ANC is not \> being monitored, during every cycle.\> Doses for subsequent cycles will be determined by the absolute neutrophil (ANC) or platelet nadir from the previous cycle.\> Required ancillary medications are administered during all cycles as defined in the protocol.\> Cycles will be repeated every 21 days for a maximum of 6 cycles. Restaging will occur after Cycles 4 and 6.	Arm A - R-CHOP n=250 Participants Patients receive the following treatment:\> * Rituximab 375 mg/m\^2 IV infusion on Day 1 prior to CHOP chemotherapy\> * Cyclophosphamide 750 mg/m\^2 IV on Day 1\> * Doxorubicin 50 mg/m\^2 IV on Day 1\> * Vincristine 1.4 mg/m\^2 IV (2 mg cap) on Day 1\> * Prednisone 40 mg/m\^2/day PO on Days 1-5\> * filgrastim or pegfilgrastim as defined in the protocol\> Required ancillary medications is administered during all cycles as defined in the protocol.\> Cycles will be repeated every 21 days for 6 treatment cycles. Restaging will occur after Cycles 4 and 6.
Progression-Free Survival Rate at 2 and 5 Years 2-year PFS	78.9 percentage of participants Interval 73.8 to 84.2	75.5 percentage of participants Interval 70.2 to 81.1
Progression-Free Survival Rate at 2 and 5 Years 5-year PFS	68.0 percentage of participants Interval 62.1 to 74.5	66.0 percentage of participants Interval 60.2 to 72.5

SECONDARY outcome

Timeframe: Up to 5 years post-registration

The overall response rate is defined as the percentage of participants with a response (Complete Response or Partial Response)

Outcome measures

Measure	Arm B - DA-EPOCH-R n=241 Participants Patients receive the following treatment:\> Cycle 1 Doses:\> * Rituximab 375 mg/m\^2 IV infusion on Day 1 prior to EPOCH chemotherapy\> * Doxorubicin 10 mg/m\^2/day CIVI on Days 1-4\> * Etoposide 50 mg/m\^2/day CIVI on Days 1-4\> * Vincristine 0.4 mg/m\^2/day (no cap) CIVI on Days 1-4 (total 1.6 mg/m2 over 96 hours)\> * Cyclophosphamide 750 mg/m\^2 IV on Day 5 (following completion of 96 hour infusions)\> * Prednisone 60 mg/m\^2 PO BID on Days 1-5\> * Administer filgrastim 480 mcg subcutaneous daily from Day 6 until ANC \> 5000 after the \> nadir (nadir usually between Days 10-12) or for 10 days (Days 6-15) if the ANC is not \> being monitored, during every cycle.\> Doses for subsequent cycles will be determined by the absolute neutrophil (ANC) or platelet nadir from the previous cycle.\> Required ancillary medications are administered during all cycles as defined in the protocol.\> Cycles will be repeated every 21 days for a maximum of 6 cycles. Restaging will occur after Cycles 4 and 6.	Arm A - R-CHOP n=250 Participants Patients receive the following treatment:\> * Rituximab 375 mg/m\^2 IV infusion on Day 1 prior to CHOP chemotherapy\> * Cyclophosphamide 750 mg/m\^2 IV on Day 1\> * Doxorubicin 50 mg/m\^2 IV on Day 1\> * Vincristine 1.4 mg/m\^2 IV (2 mg cap) on Day 1\> * Prednisone 40 mg/m\^2/day PO on Days 1-5\> * filgrastim or pegfilgrastim as defined in the protocol\> Required ancillary medications is administered during all cycles as defined in the protocol.\> Cycles will be repeated every 21 days for 6 treatment cycles. Restaging will occur after Cycles 4 and 6.
Response Rate	86.7 percentage of participants	88.0 percentage of participants

SECONDARY outcome

Timeframe: Up to 5 years post-registration

Overall survival is defined as the time from randomization to death due to any cause. The overall survival (OS) rate (percentage of participants who are still alive) at 2 and 5 years Kaplan Meier estimates and 95% confidence intervals are reported below.

Outcome measures

Measure	Arm B - DA-EPOCH-R n=241 Participants Patients receive the following treatment:\> Cycle 1 Doses:\> * Rituximab 375 mg/m\^2 IV infusion on Day 1 prior to EPOCH chemotherapy\> * Doxorubicin 10 mg/m\^2/day CIVI on Days 1-4\> * Etoposide 50 mg/m\^2/day CIVI on Days 1-4\> * Vincristine 0.4 mg/m\^2/day (no cap) CIVI on Days 1-4 (total 1.6 mg/m2 over 96 hours)\> * Cyclophosphamide 750 mg/m\^2 IV on Day 5 (following completion of 96 hour infusions)\> * Prednisone 60 mg/m\^2 PO BID on Days 1-5\> * Administer filgrastim 480 mcg subcutaneous daily from Day 6 until ANC \> 5000 after the \> nadir (nadir usually between Days 10-12) or for 10 days (Days 6-15) if the ANC is not \> being monitored, during every cycle.\> Doses for subsequent cycles will be determined by the absolute neutrophil (ANC) or platelet nadir from the previous cycle.\> Required ancillary medications are administered during all cycles as defined in the protocol.\> Cycles will be repeated every 21 days for a maximum of 6 cycles. Restaging will occur after Cycles 4 and 6.	Arm A - R-CHOP n=250 Participants Patients receive the following treatment:\> * Rituximab 375 mg/m\^2 IV infusion on Day 1 prior to CHOP chemotherapy\> * Cyclophosphamide 750 mg/m\^2 IV on Day 1\> * Doxorubicin 50 mg/m\^2 IV on Day 1\> * Vincristine 1.4 mg/m\^2 IV (2 mg cap) on Day 1\> * Prednisone 40 mg/m\^2/day PO on Days 1-5\> * filgrastim or pegfilgrastim as defined in the protocol\> Required ancillary medications is administered during all cycles as defined in the protocol.\> Cycles will be repeated every 21 days for 6 treatment cycles. Restaging will occur after Cycles 4 and 6.
Overall Survival Rate at 2 and 5 Years 2-year OS rate	86.5 percentage of participants Interval 82.3 to 91.0	85.7 percentage of participants Interval 81.4 to 90.2
Overall Survival Rate at 2 and 5 Years 5-year OS rate	77.5 percentage of participants Interval 72.2 to 83.2	78.5 percentage of participants Interval 73.4 to 83.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years post-registration

Outcome measures

Outcome data not reported

Adverse Events

Arm A - R-CHOP

Serious events: 232 serious events

Other events: 94 other events

Deaths: 53 deaths

Arm B - DA-EPOCH-R

Serious events: 214 serious events

Other events: 119 other events

Deaths: 56 deaths

Serious adverse events

Measure	Arm A - R-CHOP n=243 participants at risk Cycles will be repeated every 21 days for 6 treatment cycles. Restaging will occur after Cycles 4 and 6.	Arm B - DA-EPOCH-R n=237 participants at risk Cycles will be repeated every 21 days for a maximum of 6 cycles. Restaging will occur after Cycles 4 and 6.
Cardiac disorders Myocardial ischemia	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Blood and lymphatic system disorders Febrile neutropenia	9.5% 23/243 • Number of events 26 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	18.1% 43/237 • Number of events 64 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Blood and lymphatic system disorders Hemoglobin decreased	79.4% 193/243 • Number of events 488 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	84.8% 201/237 • Number of events 564 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Blood and lymphatic system disorders Spleen disorder	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Cardiac disorders Atrial fibrillation	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Cardiac disorders Cardiac disorder	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Cardiac disorders Left ventricular failure	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Cardiac disorders Palpitations	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Cardiac disorders Sinus bradycardia	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 5 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Cardiac disorders Sinus tachycardia	0.41% 1/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Ear and labyrinth disorders Ear disorder	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Ear and labyrinth disorders Hearing impaired	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Eye disorders Extraocular muscle paresis	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Eye disorders Eye disorder	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Eye disorders Photophobia	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Eye disorders Vision blurred	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.3% 3/237 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Abdominal pain	3.3% 8/243 • Number of events 8 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	4.6% 11/237 • Number of events 17 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Anal mucositis (clin exam)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Ascites	0.41% 1/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Colonic hemorrhage	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Constipation	34.6% 84/243 • Number of events 128 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	34.2% 81/237 • Number of events 119 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Diarrhea	5.3% 13/243 • Number of events 19 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	5.9% 14/237 • Number of events 14 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Dry mouth	1.2% 3/243 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Dyspepsia	1.6% 4/243 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.7% 4/237 • Number of events 5 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Esophageal mucositis (clin exam)	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Esophageal pain	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Gastritis	0.41% 1/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.3% 3/237 • Number of events 7 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Gastrointestinal disorder	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Hemorrhoids	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Ileus	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Mucositis oral (clin exam)	5.3% 13/243 • Number of events 18 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	9.7% 23/237 • Number of events 28 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Mucositis oral (funct/sympt)	7.4% 18/243 • Number of events 31 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	13.5% 32/237 • Number of events 55 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Nausea	8.6% 21/243 • Number of events 33 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	6.3% 15/237 • Number of events 25 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Oral hemorrhage	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Oral pain	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.3% 3/237 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Periodontal disease	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.3% 3/237 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Rectal pain	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Stomach pain	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Tooth disorder	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Toothache	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Vomiting	3.3% 8/243 • Number of events 9 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	3.0% 7/237 • Number of events 9 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
General disorders Chest pain	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
General disorders Chills	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.3% 3/237 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
General disorders Death NOS	1.2% 3/243 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
General disorders Disease progression	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
General disorders Edema limbs	2.9% 7/243 • Number of events 9 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	3.8% 9/237 • Number of events 12 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
General disorders Fatigue	11.1% 27/243 • Number of events 41 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	17.3% 41/237 • Number of events 60 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
General disorders Fever	2.5% 6/243 • Number of events 6 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
General disorders Gait abnormal	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
General disorders General symptom	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
General disorders Localized edema	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
General disorders Multi-organ failure	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
General disorders Pain	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
General disorders Sudden death	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Hepatobiliary disorders Gallbladder pain	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Immune system disorders Hypersensitivity	6.2% 15/243 • Number of events 18 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	3.8% 9/237 • Number of events 9 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Immune system disorders Immune system disorder	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Abdominal infection(gr 3/4 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Anorectal infection(gr 3/4 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Bladder infection(gr 0/1/2 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Bladder infection(gr 3/4 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Bronchitis(gr 0/1/2 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Bronchitis(gr 3/4 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Catheter related infection	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Catheter related infection(gr 3/4 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Colitis, infectious	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Device related infection(gr 3/4 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Esophageal infection(gr 0/1/2 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Esophageal infection(gr 3/4 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Gingival infection(gr 0/1/2 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Gingival infection(gr 3/4 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.3% 3/237 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Infection(gr 0/1/2 ANC)	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Infectious colitis(gr 3/4 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Nail infection(gr 0/1/2 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Opportunistic infection	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Otitis externa(gr 3/4 ANC)	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Otitis media(gr 3/4 ANC)	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Paranasal sinus infection(gr 0/1/2 ANC)	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Pneumonia(gr 3/4 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.3% 3/237 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Pneumonia(unknown ANC)	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Rhinitis infective	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Sepsis(gr 3/4 ANC)	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Sepsis(unknown ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Sinusitis(gr 0/1/2 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Sinusitis(gr 3/4 ANC)	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Skin infection	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Skin infection(gr 3/4 ANC)	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Tooth infection(gr 3/4 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Upper respiratory infection(gr 3/4 ANC)	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Upper respiratory infectn(gr 0/1/2 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Urinary tract infection(gr 0/1/2 ANC)	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Urinary tract infection(gr 3/4 ANC)	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Vaginal infection(gr 0/1/2 ANC)	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Wound infection	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Wound infection(gr 0/1/2 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Injury, poisoning and procedural complications Bruising	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Injury, poisoning and procedural complications Fracture	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Injury, poisoning and procedural complications Thermal burn	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Injury, poisoning and procedural complications Vascular access complication	1.6% 4/243 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.7% 4/237 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Activated partial throm time prolonged	0.41% 1/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Alanine aminotransferase increased	2.1% 5/243 • Number of events 6 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	3.0% 7/237 • Number of events 10 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Alkaline phosphatase increased	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	2.5% 6/237 • Number of events 18 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Aspartate aminotransferase increased	3.3% 8/243 • Number of events 10 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	2.1% 5/237 • Number of events 6 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Blood bilirubin increased	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.7% 4/237 • Number of events 7 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations CD4 lymphocytes decreased	0.41% 1/243 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Creatinine increased	1.2% 3/243 • Number of events 6 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	2.1% 5/237 • Number of events 8 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Gamma-glutamyltransferase increased	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.7% 4/237 • Number of events 7 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations INR increased	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Laboratory test abnormal	0.82% 2/243 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Leukocyte count decreased	29.6% 72/243 • Number of events 117 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	44.3% 105/237 • Number of events 242 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Lymphocyte count decreased	24.7% 60/243 • Number of events 114 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	36.3% 86/237 • Number of events 231 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Neutrophil count decreased	73.7% 179/243 • Number of events 331 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	80.2% 190/237 • Number of events 506 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Platelet count decreased	39.9% 97/243 • Number of events 182 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	77.6% 184/237 • Number of events 479 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Serum cholesterol increased	0.41% 1/243 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Weight loss	1.6% 4/243 • Number of events 5 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Anorexia	3.3% 8/243 • Number of events 9 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	5.9% 14/237 • Number of events 17 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Blood glucose increased	8.2% 20/243 • Number of events 37 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	10.5% 25/237 • Number of events 39 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Blood uric acid increased	0.41% 1/243 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Dehydration	9.1% 22/243 • Number of events 24 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	8.0% 19/237 • Number of events 22 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Glucose intolerance	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Serum albumin decreased	1.2% 3/243 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	5.1% 12/237 • Number of events 19 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Serum calcium decreased	1.6% 4/243 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	6.3% 15/237 • Number of events 28 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Serum calcium increased	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Serum glucose decreased	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	2.1% 5/237 • Number of events 10 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Serum magnesium decreased	1.6% 4/243 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.7% 4/237 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Serum magnesium increased	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	2.1% 5/237 • Number of events 11 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Serum phosphate decreased	2.1% 5/243 • Number of events 5 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	5.1% 12/237 • Number of events 14 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Serum potassium decreased	2.1% 5/243 • Number of events 6 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	12.2% 29/237 • Number of events 44 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Serum potassium increased	0.82% 2/243 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Serum sodium decreased	2.1% 5/243 • Number of events 5 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	2.5% 6/237 • Number of events 7 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Serum sodium increased	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.3% 3/237 • Number of events 5 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Serum triglycerides increased	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Tumor lysis syndrome	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Musculoskeletal and connective tissue disorders Arthralgia	2.1% 5/243 • Number of events 5 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	3.4% 8/237 • Number of events 9 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Musculoskeletal and connective tissue disorders Arthritis	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Musculoskeletal and connective tissue disorders Back pain	2.5% 6/243 • Number of events 7 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	2.1% 5/237 • Number of events 5 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Musculoskeletal and connective tissue disorders Bone pain	1.6% 4/243 • Number of events 5 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	7.2% 17/237 • Number of events 28 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.3% 3/237 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Musculoskeletal and connective tissue disorders Muscle weakness	0.41% 1/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	2.1% 5/237 • Number of events 6 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Musculoskeletal and connective tissue disorders Myalgia	2.5% 6/243 • Number of events 8 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.3% 3/237 • Number of events 5 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Musculoskeletal and connective tissue disorders Myositis	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Musculoskeletal and connective tissue disorders Neck pain	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Musculoskeletal and connective tissue disorders Pain in extremity	2.5% 6/243 • Number of events 7 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.3% 3/237 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Arachnoiditis	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Ataxia	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Cognitive disturbance	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Depressed level of consciousness	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Dizziness	4.1% 10/243 • Number of events 11 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	3.4% 8/237 • Number of events 10 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Dysgeusia	1.6% 4/243 • Number of events 6 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.7% 4/237 • Number of events 7 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Encephalopathy	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Extrapyramidal disorder	0.41% 1/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Headache	2.5% 6/243 • Number of events 8 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	5.9% 14/237 • Number of events 15 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Intracranial hemorrhage	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Neuralgia	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Neurological disorder NOS	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Peripheral motor neuropathy	9.5% 23/243 • Number of events 31 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	15.2% 36/237 • Number of events 62 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Peripheral sensory neuropathy	42.8% 104/243 • Number of events 186 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	59.5% 141/237 • Number of events 322 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Syncope	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Tremor	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Psychiatric disorders Agitation	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Psychiatric disorders Anxiety	0.82% 2/243 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	2.1% 5/237 • Number of events 7 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Psychiatric disorders Confusion	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Psychiatric disorders Depression	2.1% 5/243 • Number of events 8 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	3.0% 7/237 • Number of events 9 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Psychiatric disorders Insomnia	3.3% 8/243 • Number of events 11 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	2.1% 5/237 • Number of events 6 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Psychiatric disorders Libido decreased	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Psychiatric disorders Psychosis	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Renal and urinary disorders Cystitis	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Renal and urinary disorders Kidney pain	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Renal and urinary disorders Renal failure	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Renal and urinary disorders Urinary frequency	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Renal and urinary disorders Urinary retention	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Reproductive system and breast disorders Erectile dysfunction	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Reproductive system and breast disorders Gynecomastia	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Reproductive system and breast disorders Pelvic pain	0.41% 1/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Reproductive system and breast disorders Testicular hemorrhage	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Reproductive system and breast disorders Vaginal hemorrhage	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	1.2% 3/243 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.7% 4/237 • Number of events 6 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Cough	2.5% 6/243 • Number of events 7 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	3.8% 9/237 • Number of events 12 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Dyspnea	1.6% 4/243 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	4.6% 11/237 • Number of events 17 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis (funct/sympt)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Pharyngeal stenosis	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	1.2% 3/243 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.82% 2/243 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Voice alteration	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Skin and subcutaneous tissue disorders Alopecia	5.3% 13/243 • Number of events 23 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	3.4% 8/237 • Number of events 19 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Skin and subcutaneous tissue disorders Body odor	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Skin and subcutaneous tissue disorders Hand-and-foot syndrome/reaction	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.7% 4/237 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Skin and subcutaneous tissue disorders Pruritus	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Skin and subcutaneous tissue disorders Rash desquamating	1.2% 3/243 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.7% 4/237 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Skin and subcutaneous tissue disorders Skin disorder	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Skin and subcutaneous tissue disorders Skin ulceration	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Skin and subcutaneous tissue disorders Sweating	2.5% 6/243 • Number of events 8 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Vascular disorders Flushing	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Vascular disorders Hemorrhage	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Vascular disorders Hot flashes	0.41% 1/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Vascular disorders Hypertension	0.82% 2/243 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	3.8% 9/237 • Number of events 12 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Vascular disorders Hypotension	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	3.0% 7/237 • Number of events 11 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Vascular disorders Thrombosis	2.5% 6/243 • Number of events 6 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.7% 4/237 • Number of events 5 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Vascular disorders Vascular disorder	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).

Other adverse events

Measure	Arm A - R-CHOP n=243 participants at risk Cycles will be repeated every 21 days for 6 treatment cycles. Restaging will occur after Cycles 4 and 6.	Arm B - DA-EPOCH-R n=237 participants at risk Cycles will be repeated every 21 days for a maximum of 6 cycles. Restaging will occur after Cycles 4 and 6.
Nervous system disorders Syncope	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.3% 3/237 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Psychiatric disorders Anxiety	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.3% 3/237 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Periodontal disease	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Small intestinal obstruction	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Blood and lymphatic system disorders Blood disorder	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Blood and lymphatic system disorders Febrile neutropenia	10.7% 26/243 • Number of events 27 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	18.6% 44/237 • Number of events 57 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Blood and lymphatic system disorders Hemoglobin decreased	32.9% 80/243 • Number of events 126 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	48.9% 116/237 • Number of events 199 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Blood and lymphatic system disorders Lymphatic disorder	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Cardiac disorders Asystole	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Cardiac disorders Atrial fibrillation	1.6% 4/243 • Number of events 5 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	2.5% 6/237 • Number of events 7 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Cardiac disorders Atrial flutter	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Cardiac disorders Atrial tachycardia	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Cardiac disorders Cardiac disorder	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Cardiac disorders Cardiopulmonary arrest	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Cardiac disorders Left ventricular dysfunction	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Cardiac disorders Left ventricular failure	2.5% 6/243 • Number of events 6 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.3% 3/237 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Cardiac disorders Myocardial ischemia	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Cardiac disorders Sinus bradycardia	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Cardiac disorders Sinus tachycardia	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	3.0% 7/237 • Number of events 7 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Ear and labyrinth disorders Ear pain	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Ear and labyrinth disorders Hearing impaired	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Endocrine disorders Adrenal insufficiency	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Abdominal pain	4.1% 10/243 • Number of events 11 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	3.4% 8/237 • Number of events 9 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Ascites	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Colitis	0.41% 1/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Colonic hemorrhage	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Constipation	7.4% 18/243 • Number of events 20 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	14.8% 35/237 • Number of events 45 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Diarrhea	3.3% 8/243 • Number of events 9 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	5.9% 14/237 • Number of events 15 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Duodenal hemorrhage	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Duodenal stenosis	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Dyspepsia	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Dysphagia	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	3.0% 7/237 • Number of events 7 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Esophagitis	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Fecal incontinence	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Gastric hemorrhage	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Gastric perforation	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Gastritis	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Ileal perforation	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Ileus	1.6% 4/243 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	2.1% 5/237 • Number of events 6 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Jejunal obstruction	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Malabsorption	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Mucositis oral (clin exam)	1.2% 3/243 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	5.5% 13/237 • Number of events 19 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Mucositis oral (funct/sympt)	2.1% 5/243 • Number of events 5 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	7.2% 17/237 • Number of events 21 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Nausea	3.7% 9/243 • Number of events 9 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	5.5% 13/237 • Number of events 15 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Oral pain	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.3% 3/237 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Small intestinal perforation	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Small intestinal stenosis	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Gastrointestinal disorders Vomiting	2.5% 6/243 • Number of events 6 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	4.6% 11/237 • Number of events 12 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
General disorders Chest pain	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.7% 4/237 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
General disorders Chills	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
General disorders Edema limbs	4.1% 10/243 • Number of events 11 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	2.5% 6/237 • Number of events 6 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
General disorders Fatigue	5.8% 14/243 • Number of events 17 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	8.4% 20/237 • Number of events 23 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
General disorders Fever	1.2% 3/243 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
General disorders Hypothermia	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
General disorders Ill-defined disorder	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
General disorders Pain	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.3% 3/237 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
General disorders Visceral edema	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Hepatobiliary disorders Gallbladder obstruction	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Hepatobiliary disorders Gallbladder pain	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Immune system disorders Cytokine release syndrome	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Immune system disorders Hypersensitivity	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	2.1% 5/237 • Number of events 5 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Immune system disorders Immune system disorder	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Abdominal infection	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Abdominal infection(unknown ANC)	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Anorectal infection(gr 0/1/2 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Appendicitis perforated	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Bladder infection(gr 0/1/2 ANC)	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Bladder infection(gr 3/4 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Bronchitis(gr 3/4 ANC)	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Catheter related infection	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Catheter related infection(gr 0/1/2 ANC)	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Catheter related infection(gr 3/4 ANC)	1.6% 4/243 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.7% 4/237 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Colitis, infectious	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Esophageal infection(unknown ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Gingival infection(gr 3/4 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Infection(gr 0/1/2 ANC)	0.82% 2/243 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	2.5% 6/237 • Number of events 6 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Infectious colitis(gr 0/1/2 ANC)	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Infectious colitis(gr 3/4 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Lip infection(gr 3/4 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Lymph gland infection(gr 3/4 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Mucosal infection(gr 3/4 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Opportunistic infection	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Pancreas infection(gr 3/4 ANC)	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Peritoneal infection(gr 3/4 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Pneumonia(gr 0/1/2 ANC)	1.2% 3/243 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Pneumonia(gr 3/4 ANC)	1.6% 4/243 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	2.1% 5/237 • Number of events 5 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Pneumonia(unknown ANC)	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Sepsis(gr 0/1/2 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Sepsis(gr 3/4 ANC)	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.3% 3/237 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Sepsis(unknown ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.3% 3/237 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Skin infection	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Skin infection(gr 3/4 ANC)	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Tooth infection(gr 3/4 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Upper respiratory infection(gr 3/4 ANC)	1.2% 3/243 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Upper respiratory infectn(gr 0/1/2 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Urinary tract infection(gr 0/1/2 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Urinary tract infection(gr 3/4 ANC)	1.2% 3/243 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	2.1% 5/237 • Number of events 6 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Vaginal infection(gr 0/1/2 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Vaginal infection(gr 3/4 ANC)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Wound infection	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Wound infection(gr 0/1/2 ANC)	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Infections and infestations Wound infection(gr 3/4 ANC)	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Injury, poisoning and procedural complications Bruising	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Injury, poisoning and procedural complications Fracture	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Injury, poisoning and procedural complications Intraop. inj. - Spinal cord	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Injury, poisoning and procedural complications Thermal burn	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Injury, poisoning and procedural complications Vascular access complication	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.3% 3/237 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Injury, poisoning and procedural complications Venous injury - Viscera	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Activated partial throm time prolonged	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.7% 4/237 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Alanine aminotransferase increased	1.2% 3/243 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	2.5% 6/237 • Number of events 6 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Alkaline phosphatase increased	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	2.1% 5/237 • Number of events 5 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Aspartate aminotransferase increased	1.2% 3/243 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.7% 4/237 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Blood bilirubin increased	1.6% 4/243 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.7% 4/237 • Number of events 5 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations CD4 lymphocytes decreased	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Cardiac troponin T increased	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Creatine phosphokinase increased	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Creatinine increased	0.41% 1/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.3% 3/237 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Leukocyte count decreased	17.3% 42/243 • Number of events 58 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	27.8% 66/237 • Number of events 106 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Lipase increased	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Lymphocyte count decreased	14.0% 34/243 • Number of events 52 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	21.5% 51/237 • Number of events 93 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Neutrophil count decreased	30.5% 74/243 • Number of events 109 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	45.1% 107/237 • Number of events 169 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Platelet count decreased	21.8% 53/243 • Number of events 73 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	45.1% 107/237 • Number of events 167 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Serum cholesterol increased	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.7% 4/237 • Number of events 6 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Investigations Weight loss	1.6% 4/243 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.7% 4/237 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Acidosis	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Alkalosis	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Anorexia	2.9% 7/243 • Number of events 7 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	2.1% 5/237 • Number of events 6 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Blood glucose increased	4.9% 12/243 • Number of events 13 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	5.5% 13/237 • Number of events 18 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Blood uric acid increased	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.3% 3/237 • Number of events 5 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Dehydration	6.6% 16/243 • Number of events 18 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	8.9% 21/237 • Number of events 28 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Serum albumin decreased	3.3% 8/243 • Number of events 10 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	8.0% 19/237 • Number of events 23 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Serum calcium decreased	2.9% 7/243 • Number of events 8 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	6.8% 16/237 • Number of events 20 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Serum calcium increased	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Serum glucose decreased	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.3% 3/237 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Serum magnesium decreased	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.7% 4/237 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Serum magnesium increased	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.7% 4/237 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Serum phosphate decreased	2.1% 5/243 • Number of events 6 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	4.6% 11/237 • Number of events 14 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Serum potassium decreased	2.1% 5/243 • Number of events 5 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	9.7% 23/237 • Number of events 28 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Serum potassium increased	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Serum sodium decreased	3.3% 8/243 • Number of events 8 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	4.2% 10/237 • Number of events 13 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Serum sodium increased	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Serum triglycerides increased	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Metabolism and nutrition disorders Tumor lysis syndrome	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Musculoskeletal and connective tissue disorders Arthralgia	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Musculoskeletal and connective tissue disorders Back pain	1.2% 3/243 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Musculoskeletal and connective tissue disorders Bone pain	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	2.1% 5/237 • Number of events 5 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Musculoskeletal and connective tissue disorders Muscle weakness	1.2% 3/243 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	3.4% 8/237 • Number of events 10 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Musculoskeletal and connective tissue disorders Muscle weakness right-sided	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Musculoskeletal and connective tissue disorders Neck soft tissue necrosis	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Musculoskeletal and connective tissue disorders Pain in extremity	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.3% 3/237 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Cognitive disturbance	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Depressed level of consciousness	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Dizziness	2.1% 5/243 • Number of events 6 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Dysgeusia	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Encephalopathy	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Headache	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Ischemia cerebrovascular	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Mini mental status examination abnormal	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Neurological disorder NOS	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Peripheral motor neuropathy	2.1% 5/243 • Number of events 5 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	6.8% 16/237 • Number of events 20 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Peripheral sensory neuropathy	10.3% 25/243 • Number of events 31 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	28.7% 68/237 • Number of events 108 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Nervous system disorders Seizure	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.3% 3/237 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Psychiatric disorders Confusion	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Psychiatric disorders Depression	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.7% 4/237 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Psychiatric disorders Insomnia	1.2% 3/243 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.7% 4/237 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Renal and urinary disorders Bladder pain	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Renal and urinary disorders Bladder spasm	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Renal and urinary disorders Cystitis	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Renal and urinary disorders Hemorrhage urinary tract	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Renal and urinary disorders Kidney pain	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Renal and urinary disorders Proteinuria	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Renal and urinary disorders Renal failure	1.6% 4/243 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	2.1% 5/237 • Number of events 5 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Renal and urinary disorders Urinary frequency	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Renal and urinary disorders Urinary retention	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Renal and urinary disorders Urogenital disorder	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Reproductive system and breast disorders Pelvic pain	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Cough	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.7% 4/237 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Dyspnea	3.3% 8/243 • Number of events 10 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	3.8% 9/237 • Number of events 10 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Hypoxia	1.6% 4/243 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	3.4% 8/237 • Number of events 9 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis (clin exam)	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.6% 4/243 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	1.3% 3/237 • Number of events 3 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Voice alteration	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Skin and subcutaneous tissue disorders Alopecia	1.6% 4/243 • Number of events 4 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	2.5% 6/237 • Number of events 6 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Skin and subcutaneous tissue disorders Decubitus ulcer	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Skin and subcutaneous tissue disorders Rash desquamating	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Skin and subcutaneous tissue disorders Skin ulceration	0.82% 2/243 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.00% 0/237 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Skin and subcutaneous tissue disorders Sweating	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Vascular disorders Flushing	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Vascular disorders Hemorrhage	0.00% 0/243 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Vascular disorders Hypertension	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.84% 2/237 • Number of events 2 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Vascular disorders Hypotension	3.3% 8/243 • Number of events 8 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	5.5% 13/237 • Number of events 15 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Vascular disorders Thrombosis	2.5% 6/243 • Number of events 6 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	4.2% 10/237 • Number of events 11 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
Vascular disorders Vascular disorder	0.41% 1/243 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).	0.42% 1/237 • Number of events 1 • Up to 5 years All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).

Additional Information

Nancy Bartlett, M.D.

Washington University School of Medicine

Phone: 314-362-5654

Email: nbartlet@wustl.edu

Results disclosure agreements

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